Complementary medicines regulations – an interpretation

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Posted 24 February 2014

René Doms is a registered pharmacist and also holds a law degree. He has been closely observing regulations pertaining to complementary medicine.

In this article, first posted to the email discussion group, DrugInfo, he shares his interpretation of the new regulations governing CAMS published in November 2013.

GOVERNMENT’S PLAN TO CLEAN-UP THE COMPLEMENTARY MEDICINES INDUSTRY IN SOUTH AFRICA

1.   INTRODUCTION

The government through the Department of health has started the implementation of their plan to clean up the complementary medicines industry in South Africa, as we know it. The Director General of health is responsible for this task. Her powers flow form the Medicines Act. She does so through her inspectorate appointed in terms of the Act. These powers are extensive. They are aimed at protecting public safety.

The complementary medicines clean-up plan is straight forward and clear (see roadmap slides – www.mccza.com):

  • Withdraw banned products;
  • Withdraw scheduled substances;
  • Withdraw medicines not fitting definition of CAMs; and
  • Submit new CAMs.

The bullet pointed robust message needs explanation as it has a considerable impact on the complementary medicines industry. When fully implemented, the nature and characteristic of this industry will change dramatically, possibly be unrecognisable as we know it today.

The MCC’s powers to regulate originate from the Medicines Act itself as well as our administrative law, underpinned by the Constitution. Although the right freely to engage in economic activity is an important right in an open and democratic society based on freedom and equality, the Medicines Act limits this right. Its purpose is to achieve the widest and most efficient form of regulation and control of medicines in the interests of the public.

In determining whether or not the registration or availability of a medicine is in the public interest, the MCC may only consider the safety, quality and therapeutic efficacy’s merits of the medicine in relation to its effect on the health of man or any animal. The significance of such purpose speaks for itself – without proper regulation and control the health of the public would be threatened (Reitzer Pharmaceuticals (Pty) Ltd v Registrar of Medicines and another 1998 (9) BCLR 1113 (1998 (4) SA 660) (T)).

2.   WITHDRAW BANNED PRODUCTS FROM THE MARKET – MCC ADMINISTRATIVE LAW DECISION

There are a number of products that the Medicines Control Council (MCC) considers undesirable for use in medicines – banned substances for consumption in medicines. These substances are hazardous to health. The list has grown over a period of many years. The substances are: Apiol, Damiana, Kava-kava, Senecio plant species – pyrrolizidine alkaloids and Yohimbine. Any so-called complementary medicine containing any of these substances must immediately be withdrawn from the market as it poses a risk to public safety.

3.   WITHDRAW SCHEDULED SUBSTANCES – MCC ADMINISTRATIVE LAW DECISION

More correctly, any medicine containing a substance listed in Schedule 1 and higher to the Medicines Act must immediately be withdrawn from the market as the substances contained in these unregistered self-styled complementary medicines pose a risk to public safety.

There are a large number of self-styled complementary medicines that contain these scheduled substances. Common are milk thistle (silymarin), Red yeast rice (lovastatin), slimming preparations (sympathomimetics), vitamins, minerals and probiotics in high doses, proteolytic enzymes, melatonin and phospholipids to mention a few frequently found in complementary medicines.

4.   WITHDRAW MEDICINES NOT FITTING DEFINITION OF CAMS – CRIMINAL LAW

These medicines are misbranded, self-styled complementary medicines falling within Category A in Regulation 25 that require registration prior to sale. No person may sell any medicine that is subject to registration unless it is registered (Medicines Act section 14(1)).

Categorisation of such medicines is more difficult to establish as it entails the categorisation of the medicine in question into either a Category A or D medicine. Category A medicines necessitate registration prior to sale whereas complementary medicines as defined in regulation presently available on the market may continue to be sold provided they are labelled correctly and do not contain any Schedule 1 or higher substances.

The Medicines Act proscribes that no person may sell any medicine that does not comply with its prescribed requirements (Section 19(1)). It is a criminal offence to do so. These self-styled Category A complementary medicines are misbranded and must be withdrawn from the market as they are illegal and pose a risk to public safety.

A Category D complementary medicine (edited definition – “allied practitioner medicine”) means any substance or mixture of substances that:

  1. Originates from plants, minerals or animals;
  2. Is used in assisting the innate healing power of humans to mitigate, modify, alleviate or prevent illness or the their symptoms or abnormal physical or mental state; and
  3. Is used in accordance with the practice of the professions of Ayurveda, Chinese medicine and acupuncture, chiropractic, homeopathy, naturopathy, osteopathy, phytotherapy and therapeutic aromatherapy and Unani Tibb.

A Category A medicine (“general medicine”) means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in—

  1. The diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or
  2. Restoring, correcting or modifying any somatic or psychic or organic function in man,

and includes any veterinary medicine.

A Category A medicine – general medicine – is therefore a substance used to diagnose, treat, mitigate, modify or prevent a disease or affect a physiological function – structure/function claim. Whereas, a Category D complementary medicines – allied practitioner medicine – is a substance of natural origin, designed to assist the innate healing powers of the body in illness management within allied practitioner’s practices. Most, if not all Category A medicines – general medicine – have been called up for registration.

There is a considerable difference in the scope and reach of the two definitions. A category A medicine – general medicine – goes much further. The second part of the Category A medicine’s definition has been deleted from the Category D medicine’s definition – effects a physiological function or structure/ function claims (US terminology) as explained below.

The latter complementary medicine – allied practitioner medicine – as defined in the regulation is designed to take care of the whole medical system that sits outside the framework of the biomedical structure of medicine as generally practised in our medical schools. This is necessary to cater for the constitutional imperative entitling people to practice their culture. It provides for different world views. Whole medical systems are built upon theories and practices that have evolved apart from, and earlier than, the biomedical or conventional medical approach. Allied practitioners generally make use of this practice as controlled by the Allied Health Professions Act, No 63 of 1982.

The definition of a disease is very broad. It may be defined as an impairment of health or a condition of abnormal functioning. Its terminology is referenced in the ICD 10 code of the WHO as used in South Africa. Disease best refers to an abnormal condition affecting an organism. This abnormal condition could be due to infection, degeneration of tissue, injury/trauma, toxic exposure, development of cancer, etc. This is what needs to be ‘cured’, especially if it’s life-threatening. While illness is the feelings that might come with having a disease. Feelings like pain, fatigue, weakness, discomfort, distress, confusion, dysfunction, etc. – the reasons people seek healthcare – and usually the way people measure their success with treatment.

It’s very important to appreciate that feelings of illness can be vastly affected by many non-disease factors, such as expectations, beliefs, fears, feelings/moods, and culture. Being ill is a very personal experience, and can vary tremendously and be affected by very different things between people with the same ‘disease’.

It is clear from the RSA ’s labelling disclaimer that an unregistered complementary medicine may not diagnose, treat, cure or prevent any disease nor may it effect any physical, mental or physiological function i.e. make a structure/function claim as the latter is excluded from the complementary medicine’s definition. But more about this later.

Common Category A misbranded self-styled complementary medicines include multivitamin preparations,  probiotic and those that affect a physiological function such as hormone replacement therapy medicines (HRT), bio identical hormones, diagnose or treat diseases such as infections and parasites, neoplasms (cancer), blood disorders, disorders of the immune system, endocrine disease, metabolic diseases, endocrine disease, diseases of eye, nervous system, circulatory, respiratory, digestive, skin genito-urinary and musculo-skeletal systems. Self-styled DSHEA complementary medicines will be unlikely to survive regulatory scrutiny. Most are category A medicines requiring registration before sale because they are making structure function claims which are not excluded from the scope of the Medicines Act.

Any product that affects a physiological function – structure/function claim is also classified as a Category A medicine because this arm of the definition does not appear in the regulatory definition for a complementary medicine that is limited to the alleviation of an illness. Such products include slimming preparations, claims such as boosts, burns fat, calming, helps when crossing time zones, maintains normal mood balance, water balance, increases metabolic rate, repairs, restores, stimulates, stops craving and strengthens the immune system, amongst others.

All medicines are Category A medicines unless there are specific characteristic that indicate otherwise. Generally the product’s category should speak for itself through its presentation. Homeopathic remedies will contain potentised ingredients and the starting substances found in recognised homeopathic references such as homeopathic pharmacopoeias. Ayurvedic preparations are based on the doshas of Vata, Pitta and Kapha. Substances and formulations are found in the Ayurvedic Pharmacopoeia of India.

Traditional Chinese medicine (TCM) is based on Yinyangism (i.e., the combination of Five Phases theory with Yin-yang theory). While Unani medicine is founded on the concept of the four humours: Phlegm (Balgham), Blood (Dam), Yellow bile (Ṣafrā’) and Black bile (Saudā’).

It must be noted that so-called “dietary supplements” which make medicinal claims, including those of “supporting” or “assisting the body”, satisfy the statutory definition of a medicine. Also, that foreign statutes such as the United States Dietary Supplements, Health and Education Act 1994 (DSHEA) are not law in South Africa and thus have no bearing on the conduct of bodies such as the Medicines Control Council.

5.   DSHEA AND THE MODERN SOUTH AFRICAN COMPLEMENTARY MEDICINES INDUSTRY

The majority of complementary medicines brands as we know them on the shelves of the various retail chains, is built on the DSHEA model as practised in the US. The Dietary Supplement Health and Education Act of 1994 (DSHEA) is not law in South Africa. There is no similar statute in our country. There is no “food” safe harbour for these medicinal products. Our medicines law is different. Products based on the DSHEA model clash with our Medicines Act. The Medicines Act prevails in such circumstances.

Generally, a person can only consume a foodstuff or medicine, as defined. If in doubt, the Medicines Act will triumph. Such dietary supplements including body building products are regulated either as foodstuffs or medicines depending on how they present to the consumer or are generally used. They may not contain Schedule 1 and higher substances.

So what is the difference between the DSHEA model and our Medicines Act? The answer lies in the US Federal Food, Drug, and Cosmetic Act (FD&C Act). It spawns the exemption permitted for the sale of dietary supplements in the US but not in our country.

21 US Code chapter 9, subchapter II defines a drug as (abbreviated for clarity):

(g) (1) The term “drug” means:

(A) Articles… and

(B) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

(C) Articles (other than food) intended to affect the structure or any function of the body of man or other animals; and

(D) Articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement … is not a drug under clause (C) solely because the label or the labelling contains such a statement. [Structure/function claim but not so in our Medicines Act – these products are classified as medicines in South Africa.] A US defined dietary supplement is:

(ff) The term “dietary supplement”—

(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).

In terms of US law, dietary supplements containing the listed substances (vitamins, minerals, amino acids and extracts form plant etc) may make therapeutic or medical claims without being classified as a drug or medicine. This is not the case in South African law as no such exemption exists in the Medicines Act. Products making such claims directly or by implication are classified as Category A medicines as they do not comply with the regulatory definition for a complementary medicine. Such category A medicines require registration prior to sale. Body building products can hardly fall within the scope of an allied practitioner’s practice. A number of these so called DSHEA complementary medicines also contain Schedule 1 and higher substances, some that may only be made available on prescription in South Africa. This poses a potential risk to public safety.

The Medicines Act is “use” based. The seller’s intention is not the only consideration taken into account when determining what a product is used for in the circumstances or for its classification. Evasive or deceptive tactics are not acceptable when in fact the products falls within a particular provision of the Medicines Act. A product that has been used for years and promoted as a medicine to the public unexpectedly does not become a foodstuff because it now suits the seller. Such a product continues to retain its medicinal or therapeutic characteristic as a medicine in the minds’ of the consumer. Simple side-steps or thinly veiled disguises are hollow in law. Such products continue their existence as medicines. The consumers use such products for therapeutic purposes.

NOTE: Structure/function claims (DSHEA model) are not exempted from the Medicines Act provisions. Products bearing such claims are most likely unregistered Category A medicines – general medicines – requiring registration before sale.

However, each product must be assessed on its own merits. The legal categorisation principles should not be applied in a vacuum. If uncertain about the categorisation of a particular product, it is advisable to discuss it with the regulator. A large number of misbranded self-styled complementary medicines are negatively struck by this new addition to the Medicines’ legislation.

6.   SUBMIT NEW CAMS – MCC ADMINISTRATIVE LAW

Medicines are called up for registration in terms of section 14(2) of the Medicines Act. The MCC may from time to time by resolution approved by the Minister, determine that a medicine or class or category of medicines or part of any class or category of medicines mentioned in the resolution is subject to registration.

Products (complementary medicines must comply with the regulatory definition and not be misbranded, self-styled complementary medicines) at the time of the call up that were available on the market may continue with sale (“grandfathered”) until registered or rejected by the MCC after due process. This can take about 2 years if all the documents are in order. However, often the MCC would ask for further particular which may take the applicant time to collect. This will extend the period for registration depending on how long it takes for the applicant to respond to the query.

Complementary medicines complying with the regulatory definition that were not available for sale before the call up notice (15 November 2013) may not be sold until registered.

The regulations published on 15 November 2013 contained call up notices for complementary medicines as defined in the regulation. The pertinent call up notice reads:

Regulation 48C 2 (d) (ii) Complementary medicines falling in category D and in the pharmacological classifications as per Regulation 25(2) and (3) [all pharmacological classifications] that become available after the date of publication of this notice shall be subjected to registration as per the provisions of the Act.

There are two points of note. No new complementary medicines may be put on the market unless registered. Secondly, the product must comply with the regulatory definition for a complementary medicine. Medicines submitted that are otherwise (Category A medicine) will probably be rejected by the regulatory authority. In other words, the Category D complementary medicines call up notice for new Category D medicines has “closed” – no sale of a new complementary medicine unless registered.

7.  GRANDFATHERING

This concept is ill understood by sellers of self-styled complementary medicines. “Grandfathering” is an exemption that allows persons to continue with an activity they were engaging in before it became illegal through a change in regulation. For instance, if a product was on the market when the law changed it may continue with sale until registered or rejected. Section 14(3) of the Medicines Act creates this vested right of sale pending final adjudication of the product. Such products must be labelled with the valid application number issued by the MCC at the time.

No complementary medicines submitted after 1990 are grandfathered. They do not have a vested right of sale. In the Treatment Action Campaign and another v Rath and others [2008] 4 All SA 360 (C) case, Judge Zondi ruled that in his view it was not the purpose of the 2002 call up notice to subject to registration the nutritional substances (so called complementary medicines) mentioned in the notice. Its primary purpose was to bring the substances about which medicinal claims are made to the attention of the MCC for it to determine the correctness of the claims and whether the claims constitute a public health hazard. The notice states categorically that submission of an application in its response would not constitute product registration but would be considered a primary step in the registration process. The 2002 notice does not render the substances it identifies subject to registration as medicines. It renders them “subject to a call-up process instituted as a primary step towards registration of such as medicines. In other words the substances identified in the 2002 notice do not automatically become registrable.

Consequently, the 2002 call up notice was an “audit” and not a call up notice as understood in terms of Section 14(2) of the Medicines Act.  Registry audit numbers are therefore not valid application numbers as issued in terms of the Medicines Act. They have no force or effect in law nor do they create a moratorium permitting the sale of these self-styled complementary medicines so submitted for audit purposes until registered. Only complementary medicines on the market on 15 November 2013 that comply with the regulatory definition of a complementary medicine may continue with sale until registered or rejected after due process. It is illegal to sell a misbranded self-styled complementary medicine.

In 2010 the Registrar of medicines sent out a circular telling the industry that a registry number issued in terms of the 2002 audit did not entitle one to sell the product.

8.  SUMMATION

In sum, the Medicines Act, the roadmap issued by the Registrar of medicines read with the regulations and guidelines for complementary medicines instructs one to:

  1. Immediately withdraw products from the market that contain: apiol, damiana, kava-kava, Senecio species – pyrrolizidine alkaloids and Yohimbine as they are potentially hazardous and  pose a risk to public health and safety – MCC administrative law resolution;
  2. Immediately withdraw all misbranded unregistered non-grandfathered products without a valid application number (Section 14(3)) and not a registry audit number containing Medicines Act Section 22A substances listed in Schedule 1 and higher as they pose a potential risk to public health and safety – MCC administrative law resolution;
  3. Withdraw all misbranded self-styled complementary medicines that do not comply with the regulatory definition for a complementary medicine as they are considered Category A medicines, previously called up for registration and currently in conflict with the provisions of the Medicines Act (Section 14(1)) – Criminal law offence; and
  4. Submit all new complementary medicines meeting the regulatory definition for registration prior to sale – MCC administrative law resolution.

9.   CONCLUSION

The regulatory framework to control the complementary medicines industry in South Africa is all embracing and pervasive. The process to clean up the market has begun. Its impact will slowly start filtering through into the public domain. Product recalls will drive and highlight the progress. A large number of products presently available to the public will not meet the very restrictive regulatory criteria and will have to be withdrawn from the market.

René Doms FPS
Healthcare Regulatory Consultant
Dip Pharm Adv Dip (B&A) BIuris LLB
South African Registered Pharmacist
Fellow of the Pharmaceutical Society of South Africa
Phone: +27 11 884 4888 Fax: +27 86 617 1614 Mobile: +27 82 555 7621
Website: Forensic Pharmacy Corner
Email: [email protected]

CamCheck posts related to MCC (Medicines Control Council) 

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105 Responses to Complementary medicines regulations – an interpretation

  1. Denzil Wait 24 February, 2014 at 1:58 pm #

    Good Day

    Thank you for the details listed above. I have a product that is registered with the MCC. It was done so in 2009. It is for a fat burner It is an imported product. Based on what i have read here would i have to resubmit an application. Get an application number and then have that on the label of the product coming into SA?

    I hope that you can advise

    Regards
    Denzil Wait
    date: 24/2/2014 @ 14h00

    • Harris 24 February, 2014 at 2:11 pm #

      @Denzil
      Not straightforward at all. My interpretation is that your product is dead-in-the-water. It either fits in Category A, i.e., you have to prove that there are studies showing the product works, or Category D, the ingredients/product has a traditional history of use for weight-loss by health disciplines recognised by the Allied Health Professions Council. I suggest you contact Rene Doms for more info.

  2. Rene Doms 24 February, 2014 at 6:01 pm #

    Hello Denzil
    Are you sure that this “fat burner” is a registered medicine? If so, what is its registration number?

    • Bradley Shaw 24 March, 2015 at 2:10 pm #

      Good day ,
      I would like to sell an australian herbal and homeopathic product for animals. It is made in registered laboratory in Australia. The website is http://www.holisticanimalmedicines.com. Is it legal for me to sell this product or what must I do for me to legally sell it.

  3. Leeanne Obsowitz 28 February, 2014 at 8:36 pm #

    I have a product on the market containing magnesium peroxide, vitamin c and bioflavonoids. Can you advise as to whether you believe it will be able to remain on the market – ie which category does it fall under; Category A? If this category, what are the implications if it remains on the market as is? Will one be targeted if one should just wait and see whether the new regulations can/will be enforced? Many thanks.

  4. Rene Doms 1 March, 2014 at 9:10 am #

    This product would fall within Category A and consequently a misbranded self-styled complementary medicine that does not comply with the regulatory definition of a complementary medicine and therefore breaches the provisions of the Medicines Act – requires registration before sale. It makes you liable to criminal prosecution if you do not withdraw the product from the market. Discuss with the law enforcement unit of the Department of health for further clarity.

  5. Alok Sharama 12 March, 2014 at 6:55 am #

    The new guidelines are highly appreciated, would also request MCC to control the current exorbitant prices of these food supplements.

  6. Bianca 19 March, 2014 at 10:19 am #

    So for products registered before 1990, can they be considered ‘grandfathered’? And if they can be considered grandfathered products, will they also need to be removed from the market if they do not fall under 1 of the 6 disciplines of complementary medicine.

  7. Shaun Miller 25 March, 2014 at 12:57 pm #

    Good day. Our company produces natural enzymes which are extracted and purified from organic plant and animal tissue matter. These enzymes are only supplied to overseas customers in various industries (diagnostic, cosmetic, pharmaceutical, research). We do not not make any therapeutic claims for the enzymes produced which is supplied as a raw material substance to the customer. We do not market the enzymes as a medicine or final product.The end user application is at the customer’s discretion. Would our company still be expected to comply with the CAM regulations? Especially in terms of registration and GMP requirements.

  8. Roy 25 March, 2014 at 4:50 pm #

    @Shaun,

    Assuming you’re operating in South Africa, it would seem that products which have *not* yet been formulated into ‘medicines, which can be taken without further manipulation,’ would be Category B medicines.

    I don’t know what the regulator’s stance would be on exporting ‘raw materials’ to customers which have not been ‘extracted and purified’ according to GMP (Good Manufacturing Practice) requirements. As a consumer I certainly would not want to use any final product containing ‘raw materials’ that are not produced using GMP.

    As a South African I would not want ‘natural’ enzymes which are not ‘quality-controlled’ (in terms of their extraction and purification) to be exported. If they turn out to be of poor quality, it reflects badly on all of South Africa.

  9. Liat 3 April, 2014 at 5:19 pm #

    I would to say that the ban on melatonin and DHEA takes away my right to stay healthy and productive. I take 25mg DHEA a day – I am 50, and suffer from chronic migraines and Endometriosis. My Prof Gynae prescribed DHEA for me and the benefits are amazing. By banning this I will suffer, I want the right to self medicate with natural supplements, so I do not agree with the law that has been passed. I see it as a blatant disregard for people like me who need DHEA. Please don’t send me indepth legislation quotes and the like, I have read the online pdf. What has been taken away from me is the right to choose for myself and be subjected to a return of chronic migraines. Melatonin ban? Why? Do you know that people like me who suffer from PSTD because my daughter dropped dead infront of me at 13 with AVM? My brain does not make melatonin, as I am also on SSRI’s. Do you have an alternative suggestion, because as I see it, the way in which this law was signed into affect does NOT represent my best interests, nor the interests of others who use this medication for their own benefit.

    • Rene Doms 3 April, 2014 at 6:16 pm #

      I understand that the MCC have registered a melatonin product based on clinical trials which will become available shortly. You can ask your doctor to submit a section 21 application to the MCC for the continued supply of DHEA. It is a hormone that is naturally made by the human body. DHEA is considered an anabolic steroid requiring a prescription.

  10. Liat 4 April, 2014 at 7:57 pm #

    Thank you Rene, It has become a supply issue as SOLAL is no longer making it and the time it takes for trials to be completed will take too long. Could I then be able to buy it from overseas when I run out? Solal is not doing the trials.

    • Rene Doms 6 April, 2014 at 9:07 am #

      You would have to discuss the supply issue with Solal. To import an unregistered medicine into South Africa, you would need to approach the Medicines Control Council for assistance together with your healthcare provider who must be a registered medical practitioner in South Africa. Melatonin for long term treatment, is a Schedule 4 prescription only medicine. Since your problem appears chronic, I suggest you consult with your healthcare provider. Take care.

  11. Craig 13 June, 2014 at 7:56 pm #

    Hi Dom
    We market a dilute (5%) Food Grade Hydrogen peroxide supplement. What category would this fall into under the new regulations?
    Kind regards
    Craig

  12. niels 3 September, 2014 at 10:03 am #

    We applied for a complimentary status for our product which is a silver colloidal type product and gazetted as a homeopathic substance. Shortly before the new regulations came into play we were told the submission is incomplete. We have now gathered more information of a technical and scientific type. Do we provide the information and continue with our application or re-submit entirely? If we do need to re-submit what is the cut off date before we can no longer market or sell our product according to the grandfather clause.

  13. Charles 4 September, 2014 at 4:40 pm #

    Please, am having problem understanding this section. Could you please throw more light on it.

    Category D medicines
    Human and Veterinary medicines, compounded in its entirety in the RSA or not, for which an application for registration has been submitted as contemplated in Section 15 of the Act,
    in respect of the submission of an application for registration of-
    (i) Products submitted with clinical and or toxicological data: R12 400 per application;
    (ii) Products with no clinical or toxicology data: R5 500 per application.

  14. Aurelie 14 September, 2014 at 11:23 am #

    Dear Rene, I am a Doctor and am doing a thesis on a small group of children who have hepatic veno-occlusive disease, secondary to presumed muti ingestion of muti containing pyrrolizidine alkaloids.
    I’m trying to understand if the current South African law can regulate the use of pyrrolizidine containing alkaloids in traditional remedies, and if so, how would they go about it?
    Thank you very much for your summary.

  15. Christine 16 September, 2014 at 12:17 pm #

    I see these regulations as a violation of our right to choose and be healthy. I have severe problems falling asleep and have used melatonin successfully without side effects for many years. My doctor has now prescribed Tranqipam for me. On researching what this is, I find out is a benzodiazepine drug, it is habit-forming with potential to increase the risk of Alzheimers later in life. How can you possibly defend this policy? I see this as yet another move by the pharmaceutical industry and doctors to milk the consumer. This sort of legislation is draconian. Especially considering that the rest of the world is moving in the opposite direction! Why don’t you ban alcohol and the nicotine then? This is a violation of our right to choose.

    • Harris 16 September, 2014 at 6:22 pm #

      @Christine
      The regulations were not put into place to violate your rights but to prevent companies from violating your right to products being sold to you – to ensure that they are safe, the dose is correct, and that there is a good chance that they will work. Are the regulations perfect? No, but if they manage to get rid of the great number of scams and unregulated products on the market, then they are at least worthy of some praise.

      • Liat 16 September, 2014 at 7:42 pm #

        But they do violate my right to choose. Under the guise of ”safety” and over regulation, I am deprived of this product that helps me sleep. You see I too have a sleep disorder and PTSD and by legislating me out of my choice to replace the melatonin that my brain does not make anymore, I am severely compromised. Regulate it, by all means, but DO NOT remove my right to try and help myself. The policy is undefendable and wrong. Melatonin is safe and effective and recommended by doctors. It now means that 10mg of Adco Zolpidem will not be enough for me and I will have to increase my dosage. Melatonin is not a scam, there re many good products out there, and I want the choice to buy them.

  16. Roy 16 September, 2014 at 6:34 pm #

    @Christine

    Your doctor can actually prescribe melatonin for you. If there’s none available in the country, he – maybe with the help of your pharmacist – can arrange for permission from the MCC to import it – just for you! (This is called a Section 21 application, if he doesn’t know.)

  17. Christine 16 September, 2014 at 7:04 pm #

    Thanks @Roy. However, this comes at a rather hefty price tag compared to what I used to pay. Dr’s appointment, shipping, etc. I understand that it is to protect consumers (somewhat), but if this is the case, is quality control not the solution? Not complete withdrawal of a product. It’s hard to believe that pharmaceutical companies & doctors (who run the MCC), don’t automatically have a conflict of interest. We see this in many fines, MANY fines paid by pharmaceutical companies in mismarketing fines, and class action suits linked to hidden side effect data. Health care is big bucks & if banning is the only solution instead of quality control, I doubt the intentions are that honorable.

  18. Christine 16 September, 2014 at 8:19 pm #

    @Liat, I agree full-heatedly. I am disgusted that NO public consultation was conducted. Also,where is the evidence of the so-called “poor quality” & contamination? Show us the cases that promoted this “need” to protect the consumer!

  19. Christine 16 September, 2014 at 8:54 pm #

    @Harris @Roy @Liat. Amazing. I can freely obtain benzodiazepine & I have to specially import Melatonin? What is the MCC thinking?!?! Also I believe substances like N-Acetyl-Cysteine have been banned (proven to show improvement in lung function?) but NO action on so-called “Traditional Medicines”? Your conflicts & lack of care should be constitutionally invalid & are clearly politically motivated. In fact, can anyone here tell me if there is anyone who wants to launch a constitutional challenge to these ridiculous regulations? I doubt there are sufficient data to support it & I’m sure there is sufficient interest to gain a foot hold here. I’m pretty sure the vast majority of ill-findings are related to the “Traditional Medicines” making all of this just a money making racket. Why don’t the MCC publish stats to back up their ideas? Where is the freedom of information?

    • Harris 17 September, 2014 at 7:54 am #

      @Christine
      Actually melatonin can be purchased from Dis-Chem, Clicks and other pharmacies – but requires a script no differently than benzodiazepines. All that has happened, is that melatonin has been rescheduled as a Schedule 4 drug for the Medicine Control Council considers this to be a neuro-transmitter (which it is).

      • Dominique 15 November, 2014 at 2:42 pm #

        I was at clicks pharmacy today and it has been discontinued and cannot be purchased in any form anymore

  20. Roy 17 September, 2014 at 8:45 am #

    @Christine, @Liat,

    Various versions of “complementary medicines Regulations” have been commented on since 2001. There has in fact been exhaustive public (and industry) comment!

    The November 2013 Regulations did not “ban” any substances – they merely enforced previous decisions concerning “substances declared unsuitable for use” (i.e. “banned” – but still being sold by unscrupulous manufacturers) and various scheduled substances (some being sold without prescriptions as is required.

    You cannot “freely” obtain benzodiazepines – you need a valid prescription.

    N-acetyl cysteine (acetylcysteine)is not “banned.” It is a Schedule 2 substance. It was discussed in the judgment against Dr Matthias Rath who claimed his products (of which one contained N-acetyl-cysteine) could “reverse the course of AIDS.” DHEA is not “banned” – it is a Schedule 5 substance. Melatonin is not “banned” – it is scheduled. But at least one manufacturer is no longer making melatonin available to the public. This could be because they don’t consider it a sufficiently profit-making medicine – or because they don’t have the data needed for registration with the MCC. (You have no guarantee that the product you *were* taking actually contained what was on the label, and nothing else.)

    The Minister of Health himself informed parliament (and thereby the public) on 29 October 2010, that of the 155,000 products for which details had been received by the Department of Health in response to the 2002 “call up” – NONE had had any verification of quality! They could have contained anything. (The 2002 “call up” – bizarrely – did not require the submission of ANY quality, safety or efficacy DATA. It was wrongly labelled a “call up” – and was intended only to be a six month “audit.”)

    Traditional medicines will be regulated once the “Interim Traditional Health Practitioners Council” is fully functional and in dialogue with the MCC.

    Why don’t you yourself launch a Constitutional challenge to the Regulations?

  21. Christine 17 September, 2014 at 9:31 am #

    @Harris. I was in Dischem yesterday & was told all melatonin in SA had been withdrawn. So no,even with script, apparently I need to specially import it. NAC can only be obtained through ACC 200 costs way more. This just means that doctors milk the consumer as each time a script needs to obtained.

    BTW, I do have a script for Tranqipam (benzodiazepine) but now need to go back to my doc as only once I researched the bloody tablets did I find out how bad they are for me and that in response to the fact that I was still struggling with insomnia and unable to use something I used before which dud help!

    Public comment only helps if the public actually knows it’s happening. None of us monitor the various gazettes/etc. so as far as I am concerned, I had no idea this insidious process was happening. I suppose being as I am no “expert”, but just the end consumer expected to fit in with this draconian legislation, it really doesn’t matter!?

    Seriously, why don’t the MCC earn their salaries and apply a quality control approach?

  22. Liat 17 September, 2014 at 6:54 pm #

    @Roy. Your argument does not sit well with me. You know full well why it is not available and the shenanegan antics of the MCC in the over regulation of naturally occurring substances. Of course I have script for Melatonin, but I am saying it should not be made not available to the public who wish to use it. It is not that it is not financially viable to produce, it is simply the red tape and process that the verification of the substance needed to qualify for doing what it says it is supposed to with the new regulations!!!!!!!!!!! If you are in this industry, the alarm bells should be ringing loud and clear the removal of products do and can cause tremendous stress to people like me and countless others who function better on this product. I want the choice to be able to get it and use it, my body, my choice. Longevity.

    • Harris 17 September, 2014 at 10:06 pm #

      @Liat
      I think your argument is misguided.
      1. Melatonin is not a naturally occurring substance
      2. The people making the profit by selling this can continue to do so if they simply apply for registration and furnish the MCC with the correct documents, which include evidence that the product’s quality is at a standard and that there are no contaminants, among other. They appear to have decided not to – don’t blame the MCC for this.
      3. To rid the market of scams one has to set the exact same regulations to keep the playing field level. One cannot say, product x is a scam and therefore should be regulated and product y is not, therefore does not need regulation. One sets the same bar for both, those who can get over the bar continue to ply their trade and make money, those who cannot fall by the wayside.
      4. Many countries in the world regulate this ingredient, nothing unusual about this.

      The sadness here is not the fault of the MCC but Dischem, who was selling this product under their Biogen brand, and clearly decided for the company’s reasons, not to apply for registration, or not to continue producing the product because it was not profitable enough – or maybe even, that the quality of the product would not pass muster. Blame the manufacturers, not the MCC (in this case)

  23. Liat 17 September, 2014 at 11:45 pm #

    @Harris. Sorry I disagree. I have been compromised as a victim in the pharmeceutical war. The Body makes melatonin, mine does not due to PTSD. Solal told me straight. New MCC regulations, NO Melatonin will be made and it was discontinued because of the expense needed into the research of exactly how effective it is supposed to be. It works, for me and countless others who are now deprived of it under the regulations. One can say the same about the manufacture of vitamins, but let me decide which ones to buy. I can read, and research products and ingredients listed. I do not want to be legislated out of health. Regulate by all means, but not at my expense and further pain. Your argument about scams is irrelevant compared to the suffering of withdrawal of this product. You cannot buy it even on a script, the pharmacies do not sell it. I question ”other ” countries withdrawal of this and DHEA and a host of other now scripted remedies. So yes, I question the validity of any argument, on the basis of sound humane (not monetary) values. This is clearly not one of the sound judgements in favour of healthy living by choice- mine. Section 21 is no option for me. The evidence needed is the catch here? The cost of research….need I say any more?

    • Harris 18 September, 2014 at 7:57 am #

      @Liat
      My experience is that you cannot believe or trust everything that Solal tells you. Pseudoscience at its best. For example, they had a sustained/extended/slow release version of melatonin – which makes no sense at all because it is secreted diurnally. There is no evidence that ‘PTSD’ causes the pineal gland to stop making melatonin.

  24. Christine 18 September, 2014 at 9:13 am #

    It’s outrageous that the products that work are withdrawn. Citrus aurantium, garcinia Cambogia, all the products that are REALLY detrimental are still allowed & marketed.

    Another institutional failure. And just another reason why I question whether I want to live in a socialist state where more and more of my civil liberties are eroded by over zealous legislation.

    • Harris 18 September, 2014 at 9:45 am #

      @Christine
      Are you aware of what you are saying?
      You are saying that the legislation is overzealous, but the only way to prevent products that are really detrimental to health, e.g., Citrus aurantium, Garcinia, is by legislation!

      Legislation allows for products that really work to continue being sold – BUT that the manufacturers selling the product has to supply the regulators (MCC) with evidence that it does. If there is no evidence that it does, how do you know that it does and that it is not just reports of placebo effects? So if the product you feel does work, then the company should have had no difficulty supplying the MCC with evidence that it works, that the quality and other factors are sound: but for reasons we do not know, the manufacturer decided not to.

  25. Christine 18 September, 2014 at 12:24 pm #

    So why can u still by citrus aurantium and garcinia cambogia & not melatonin? Provide me with information of international, appropriately structured studies that support such?

  26. Craig 18 September, 2014 at 1:26 pm #

    Hi, those posting here in favour of the MCC regs are skirting the issue that the system has been set up now in such a way that only big pharma can afford to register products, as clinical trials cost hundreds of thousands of Rands, if not millions. Also, you are assuming this system even works! Lets take the USA as an example, where properly prescribed and administered prescription (FDA registered) drugs result in 700 000 emergency room visits and 106 000 deaths every year. One FDA approved drug, Viroxx, killed 60 000 people alone before it was removed from sale. Big Pharma’s prescription “drugs” are now the 4th leading cause of death in the US.

    How many people suffer and die from natural health products and supplements?? Hardly any, thats how many. Furthermore, the MCC has declared that any product that does not fall into an already recognised complimentary or alternative medicine category, can now only exist as a scheduled drug, even a health supplement – so no development of new natural remedies will be done, unless its by Big Pharma that can foot the huge bills. Big Pharma has effectively used this to shut down any existing or new smaller businesses from developing or supplying natural health supplements or remedies. Efforts are underway in the USA to make even Vitamin C a prescription drug.

    And as for protecting us from scams, we the public are not that stupid, if a product makes claims it cannot back up, people will just not buy it again, if the product is truly misleading, then an effective complaint reporting and investigative arm of the MCC is all that is needed.

    If you think all this is being done by the MCC with only the public’s health as a concern, you are supremely naive. Big Pharma is playing the exact same game that the Petro-Chemcial industry is playing with GMO crops, influencing legislation and governments across the world, and if you think the SA government is immune, consider this: South Africa is the ONLY country in the world where the fast majority of the population eats GMO foodstuffs as their dietary staple – yes, maize, pap etc. is all from corn, mostly GMO corn, take a look on the side of a bag of mielie meal, it says “Contains Genetically Modified Foods” – South Africa is currently running the biggest human trial of GMO foods in the world, but unfortunately by the time the results become evident it will be too late. So if you think you can trust government to look after your health, think again.

  27. Christine 18 September, 2014 at 4:04 pm #

    @Craig I couldn’t agree more!

  28. Christine 18 September, 2014 at 4:14 pm #

    @Harris. These more than not support the use of melatonin. Please send me supportive evidence for use of citrus aurantium & garcinia cambogia. They, are as best I understand it, the modern day equivalent of “snake oil”. If protecting the consumer is desired, surely that, not protecting against valid substances, would be more desirable?

    I think @Craig has the bet argument yet. I don’t trust the MCC and I don’t trust big pharmacy for exactly the reasons he mentions. I see these new regulations as a retrogressive step and unfair. Doctors deciding on how not to allow doctors to be out of pocket will always represent a conflict of interest.

    • Harris 18 September, 2014 at 5:01 pm #

      @Christine
      There are more than 40 studies on Garcinia, and the general consensus is that Garcinia does not result in clinically significant weight loss (and at dosages much higher than generally sold by the snake oil salesman. Hence the new MCC regulations which are aimed at curbing these products from being sold.

      Furthermore, I need to be clear, I also do not fully trust the MCC in that there are many role players all vying for attention, from the snake oil salesman, politicians, scientists, etc. But consider this: there are more than 155,000 unregulated products on the market, and the only way to regulate them is to show the same standard required for all. Therefore some products will appear to be ‘hit’ harder than others. Those that fit the CAM paradigm allowed by the MCC will require a different set of proof than “Big Pharma’ products.

  29. Liat 18 September, 2014 at 9:50 pm #

    @Harris. Sorry, I disagree. I have chronic insomnia, and I am going to be facetious. My daughter died infront of me one evening 3 years age, hence my PTSD. Not very pleasant, and the side effets and effect on my brain is PTSD and the relevant lack of neurotranmitters vis a vie seratonin AND believe it or not Melatonin and incase you are wondering, it also depends on the the state of flight or fight mode that I am in, that affect me entire body. So where I can help myself, I do. Solal S/R was a product that worked for me. Period. No argument, just is. It is not pseudo science and just in case you have an issue with Solal, they have cornered the market with good products. The argument should not be that it should be ”regulated”, but what good it already does for so many people. There are many many toxic drugs manufactured that really hurt a lot of people and save a lot of people. The emphasis from MCC is not in the best interests of the public regarding Melatonin. End.

    • Harris 18 September, 2014 at 10:13 pm #

      @Liat
      Instead of critisising the MCC in trying to regulate the market, how would YOU regulate this area, i.e., the 155,000 unregulated “supplements”?

      How would you suggest the MCC differentiate fairly between something like Garcinia, melatonin, or a product claiming to contain milk thistle? In other words, if you were in charge, and have a tiny workforce, how would you suggest the MCC regulate the efficacy, quality, dose etc, of all the products on the market – and be fair to ALL manufacturers and treat them equally?

      How should the MCC decide whether a product containing melatonin of 1mg per dose is effective compared to one containing 50 mg? How should the MCC differentiate between one produced by Solal and one imported from China or Nigeria?

      • Liat 28 October, 2014 at 9:19 pm #

        Let me choose…

  30. Christine 18 September, 2014 at 11:04 pm #

    I would require a regular quality submission, with full financial responsibility committed to, if such quality failed & there were adverse results.
    This means all manufacturers put their going concern’ness behind their products.
    It’s about self regulation.
    Also production facilities should avail themselves to random inspections.
    There are many international studies supporting substances like (to try to de-emotionalize this issue) Vit C versus citrus Aurantium.
    Rely on international studies ( sometimes independently funded, but most times for alt. Meds independently funded) & allow those that prove working & promise* quality control.
    * these guys lose their livelihoods & licenses if 1 product gets kicked out.
    Do random sampling like auditors would to ensure quality.
    If quality standards are failed (substantively), the license is withdrawn, hefty fines are imposed.
    The onus is moved from the company having to prove compliance to probing quality & u impose a independent standard of reasonableness.
    Independent reasonableness is backed up with I dependent studies
    All adverse findings are highlighted for consumers to be aware, e.g. People with kidney stones should not be taking Vit C?
    I think this may work?

    • Harris 19 September, 2014 at 8:58 am #

      @Christine
      This is not very different to what the MCC is expecting, but simply that they check the proof supplied by the company to the MCC. Self regulation unfortunately does not work. For example, Solal’s Krill oil was tested a year or two ago and found not to be up to the claims they made for it. An independent body always has to check, even for Big Pharma, who have also tried to manipulate the system.

  31. rene 27 October, 2014 at 12:15 pm #

    HI there – The fact that I can no longer get Melatonin even with a prescription is violating my constitutional right. Do you know or have a contact at the Medicines Control Council I think this needs serious media attention. Thanks, regards

    • Harris 27 October, 2014 at 12:33 pm #

      @Rene
      I am curious what your response will be to these questions:
      1. If you could not get morphine without a prescription, would this violate your constitutional right?
      2. If you can get melatonin with a prescription, but no companies want to stock and sell the product, how is this violating your constitutional right?

      • Liat 28 October, 2014 at 9:17 pm #

        @Harris, I don’t know why you bother to blog such narrow minded viewpoints that have NO benefit. Regulation and law is not always ”right”. It has to be challenged. With regard to proof, you know that many companies do not have the finance to ”prove” their product already proven in the use world wide. I mean really what benefit is over regulation to the detriment of the public’s freedom to choose. I too want the choice for self medication, and to stop the over regulation occurring in all spheres in South Africa.

        • Harris 28 October, 2014 at 9:54 pm #

          @Liat
          Sorry, this is illogical and false logic. If we accept your point, then car sellers should not be regulated, nor the drug trade, nor financial institutions. Sometimes regulation is to protect individuals, in many cases it is to protect society. Regulation is ALSO to level the playing field, so that companies play with the same set of rules. The point of regulation is not always to ban products but to force a company to give enough information in order for the consumer to make a FULLY informed decision. And you are correct, regulation may be wrong and should be challenged. But if the facts support regulation, then regulation should be supported. You are using the same argument that Big Tobacco uses.

        • Andrew 9 March, 2015 at 1:43 am #

          Well said Liat. These regulations are stifling the industry and removing consumers’ right to choice. It is all well and good to regulate an industry that has the serious potential to harm the public but there is also such a thing as over-regulation. If natural substances used the world over as traditional medicine quite safely are suddenly thrown into the same camp as harmful substances there is definitely over-regulation going on and that is clearly the case when something like Melatonin is suddenly a scheduled medicine. What will be next?

          Before talking about logic @Harris should consider that this is the department that offered the African Potato for AIDS and refused to allow Neviropene for AIDS babies.

          • Harris 9 March, 2015 at 7:33 am #

            @Andrew
            The Department did NOT offer the African potato for AIDS (the whacko head of the Department of Health, Manto Tshabalala-Msimang may have endorsed its use, but the department did not).

            There is a constant illogical argument that claims that consumer choice is paramount above the risk of that choice. The constitution demands that the government protect its citizens, which means protecting them from the sale of not only unsafe products, but products that are no more than fraudulent. Lait wrote: “DO NOT remove my right to try and help myself”. If the government knows that a product contains high levels of arsenic, does the government not have a right to ban the substance, and does Lait have the right to try the product if he is misguided into believing it will work? Comfrey is a good example of this – a “natural” product that kills of the liver (which consumers are not aware of) – the government has lawed that it cannot be sold as as a therapeutic agent.

          • Andrew 9 March, 2015 at 3:44 pm #

            @Harris, it’s still within the same department. If the head of a department for health drank herself to death how can we take anything that department does seriously? It’s not just the department itself but also its attachment the MCC with silly statements like Neviropene not being proven safe enough for preventing mother to child transmissions. That has given the confidence in the department a serious knock that it is not run professionally but as a circus.

            The whole fact of the matter is that the government does not know. They are making decisions that go against what the rest of the world and the experts in the field know and they have no substantiation for them. Comfrey is not Melatonin. If you want to come with that fallacious logic you have no right to talk of using illogical or false logic.

            If you did your research on the subject you’d know like us that they are in fact removing the right to choice so they are doing the opposite of protecting us. Since these regulations were put in place I have had to import.

            • Harris 10 March, 2015 at 8:00 am #

              @Andrew
              My response, using comfrey as an example, was addressing the topic of regulation in general (the legal right of the government to protect the public) and not specifically melatonin. I have no idea why the MCC re-scheduled this drug, and I do not speak for them. I am surprised that you still associate the dysfunction of the department with Manto. She has not headed this department till 2008. Your argument suggests that the present Minister of Health will never be able to overcome her legacy?

          • RENE DOMS 10 March, 2015 at 10:10 am #

            @Andrew – it may be useful for you to examine the European Union monographs for these natural substances. Melatonin is not without its difficulties. Consequently, the MCC has scheduled melatonin. I agree with their decision.

          • Roy 10 March, 2015 at 11:46 am #

            @Andrew – I’d be interested to know if, when you import, you are declaring your imports as “medicines” (medicaments) or as food supplements? And if you’re importing for your personal use or for retail purposes.

          • Andrew 10 March, 2015 at 4:38 pm #

            @Harris, you are still ignoring what I said. The dysfunction just ends with Manto at the top but it also starts right with the MCC at the bottom. You are not addressing my example where the TAC had to threaten court action to get them to accept a drug that was both proven effective and relatively safe the world over.

            Regulation in general does not apply to specific cases. That would be like saying because cocaine is dangerous we should ban sugar. It’s a logical fallacy. You have no idea why the MCC scheduled this supplement and neither do they because they are incompetent. It’s not just Melatonin but a bunch of supplements that were scheduled with no data to back up the scheduling. I seriously urge you to let go of your preconceptions here and research the whole schedule of supplements they scheduled.

            If you think laws are necessarily there to protect you you are making a big mistake. If that was the case cigarettes would be banned as they are a lot more dangerous both to smokers and those around them.

            • Harris 10 March, 2015 at 5:03 pm #

              @Andrew
              If Manto was not in charge, but the present Minister, the TAC would not have had to threaten court action. That was the point I was making.

              Your argument “That would be like saying because cocaine is dangerous we should ban sugar” is illogical (or in your words, a logical fallacy). The logical argument is that since cocaine is dangerous, other similar cocaine-like or similar acting compounds may be and therefore regulated in the same way – but most importantly, that they have to go through the same regulatory route which will evaluate and make the decision.

              I stress, I am not arguing for, or against the case of melatonin. I have no information to guide me to understand why they changed the scheduling status. As Rene Doms has stated above: “Melatonin is not without its difficulties. Consequently, the MCC has scheduled melatonin. I agree with their decision.” Rene Doms is a pharmacist AND an Advocate.

          • Andrew 10 March, 2015 at 4:49 pm #

            @Roy, I don’t declare the imports. The shop labels them under the category of supplements or foodstuffs. They don’t ask if it’s for personal use or retail as it’s quite small quantities. It would only start drawing attention if I started importing crates or large boxes of it but then it would also not be able to go through the post or courier.

          • Liat 11 March, 2015 at 8:54 pm #

            Thanks Andrew, I was wondering why a complimentary medicines site harbored such ill will towards the very products that they are supposed to support instead of actively and maliciously try to support this atrocious behaviour. I bought 3 years worth of DHEA (another banned longevity and fertility product. So I will always find a way. The Natural Medicines Council must continue their litigation.

          • Andrew 12 March, 2015 at 4:07 am #

            @Harris: That is exactly the point I’m making. Your argument is the equivalent of saying that sugar should be banned because cocaine is dangerous. It is completely an illogical argument to make with no foundation. If a substance is dangerous you would investigate the safety of other like substances and not just ban it outright. What the MCC is doing is regulating substances that are nothing like the other regulated substances and as far removed from them as sugar is from cocaine.

            I know your point about Manto but you’re not taking my point into consideration. The decision was an MCC one and not a decision by the department which Manto was heading. That’s why it’s the entire department at fault from top to bottom like is the case with every other department that’s in disarray. If they can make such decisions they don’t inspire much confidence and the present minister allowing decisions like these to pass puts him on the same level of quackery as Manto for me.

            It’s the entire fact that you are not taking a stance and just accepting the regulations that’s bothering me. The MCC might have had a reason to schedule Melatonin but not in a way that the man on the street doesn’t have access to it. I still maintain though that I’m skeptical of that because having done my research I know they classified a whole swath of substances in a way that conflict with the real evidence available. With all due respect if you are not here to contribute to the argument one way or the other and only supporting “regulation” in ignorance I don’t think you should be commenting.

            Your whole point seems to be that regulation is there to protect which is a fallacious argument. Liat is right in that regulation should be challenged. Regulation isn’t always about protecting. Take the situation with Heroin for example. Being a legal class A drug in the U.K. less than 1% of people become addicted to it. Codeine is a much more addictive and dangerous drug. I’m sure I don’t have to tell you which is illegal here and which is available off the shelf. Same with Cannabis and Tobacco. The one you can buy is actually the dangerous one while the one that’s illegal is just a legacy leftover of political and racial control.

            • Harris 12 March, 2015 at 7:49 am #

              @Lait
              There is a disconnect here: I made is absolutely clear that I am not equating cocaine with sugar, and yet you go say “Your argument is the equivalent of saying that sugar should be banned because cocaine is dangerous.”

              You also do not seem to understand the MCC and Department of Health or the influence of the Minister of Health. The Minister of Health HEADS the whole department INCLUDING the MCC. He appoints the head of the MCC. He has massive influence and signs off on ALL MCC decisions. Manto crippled the MCC. The new minister if trying to fix the problem. Is the MCC without faults? Of course not, but that is not the point. The point is that the MCC improves or implodes under the influence of the Minister.

              Throughout the world, ALL regulators are grappling with protecting the public through regulations. Some mistakes are made but exceptions do not prove the rule. Regulations have to sometimes follow a moving target, e.g., if the way heroin, codeine, etc, gets used/abused, or new scientific information is obtained, etc., may alter the registration and regulation of that ingredient. You may recall that in 2011, the MCC changed the registration status of dextropropoxyphene based on evidence. Vioxx was stopped dead in its tracks when evidence arose regarding its dangers (and how Big Pharma tried to hide this). Same with tobacco, its status and its regulation keeps on changing based on evidence.

              You have not made a comment against the statement of Rene Doms (pharmacist and legal advocate) who supports the registration of melanonin. What is your qualifications or expertise that can counter his?

          • Andrew 12 March, 2015 at 4:17 am #

            @Liat, from past experience I can tell you this site is anything but a complimentary medicines site and just another one of those that are negative towards what they consider to be “quackery.” You can be sure that whenever the words “critical thinking” are mentioned it’s not actually about thinking at all but code for throwing common sense out the window in support of a specific agenda.

            I am interested in hearing what this litigation is.

            • Harris 12 March, 2015 at 7:29 am #

              @Andrew, Liat
              I am astounded that you do not read the “About” page of this site which makes it absolutely clear, we are NOT against CAMS per se, but CAMS making claims without any evidence. I am astounded that you cannot understand that this site is to PROTECT consumers from SCAMS, i.e., South African CAM products that make a claim that is not justified. It should be patently obvious that this site is to appose the hundreds of sites that support CAMS, either for justified or unjustified claims. The specific agenda is to cast a spotlight on only those products who make unjustified claims. You will not find a single post for a product or ingredient where there is evidence that the claims are justified. Common sense is mentioned. Common sense says that if there is no evidence that a claim is possible, that it is not justified. If you think otherwise, I would suggest you do not have any common sense.

          • Roy 12 March, 2015 at 8:31 am #

            @Andrew, Liat. I would be interested in reading any submissions you made to the MCC about the then draft Regulations during the period July 2004 onwards, if you’re willing to share them. It took the MCC a decade to publish final regulations – taking into account many comments from many different “stakeholders.” I am also interested to have more details about the “Natural Medicines Council,” Liat, as I have not heard about it before.

      • RENE DOMS 10 March, 2015 at 9:48 am #

        @Harris: No right in the constitution is absolute. Limitations apply – see S36 of the constitution. Morphine and melatonin are controlled in the public interest. They are considered dangerous substances. The Prince case (smoking dagga) is a good example of this principle.

    • Liat 28 October, 2014 at 9:10 pm #

      @Rene, if you have a script, the Compound Pharmacy will make it for you and deliver it to you own pharmacy. You will be able buy a bio identical product.

      • RENE DOMS 10 March, 2015 at 9:35 am #

        Hello Liat

        How do you know that the active is absorbed and reaches a therapeutic or supra-therapeutic/sub-therapeutic level? What dosage form are you using to deliver the drug to the body? Is the product stable, and for how long can I store it? What evidence do you have to warranty the products meets acceptable standards?

        • Liat 11 March, 2015 at 8:56 pm #

          Hi Renee, I was scripted for 12mg and the compound pharmacy does make it for me…But it does not work as well as Solal SR.

          • RENE DOMS 12 March, 2015 at 8:57 am #

            Hello Liat
            Taking high doses of melatonin (hormone) is not a good idea neither is DHEA which is an anabolic steroid. There is little scientific evidence supporting the use of DHEA nor are there well-defined indications for its use. It would be prudent only to consume these substances under the direction of a specialist physician, if needed. Long-term use can harm you. The Medicines Control Council has scheduled both of these substances and considered them dangerous and why a healthcare professional should guide you. There is a registered melatonin in South Africa but only for very restricted use. You should proceed with caution and seek medical advice and not experiment on yourself, it could lead to detrimental health consequences.

  32. Stefan Eksteen 22 January, 2015 at 3:02 pm #

    Rene, my company has a product called Brandsalf Balm. We have been trying to get this product into retail stores and pharmacies across the Republic.
    The product can be used for the following topical inflammations:
    Sunburn, Burn wounds, relief of scarring left behind by psoriasis, shingles and eczema, hemorrhoids, inflammation in the legs, fever blisters, cold sores, dark spots, acne etc

    We haven’t registered this product with the MCC as we’re not sure if it should be registered as it contains zinc oxide and eucalyptus oil extract.
    Please let me know what I have to do in order to get this product sorted.
    We have been using the disclaimer in the meantime.

    Many Thanks

  33. RENE DOMS 10 March, 2015 at 9:44 am #

    Hello Stefan

    Applying Eucalyptus oil to an open wound is not advisable. Eucalyptus oil should not be applied on broken or
    irritated skin – see European Union monograph. Is your product safe and effective? What objective clinical evidence do you have to demonstrate that the product performs according to the claim?

    Register the medicine before you sell it.

  34. Ezra 31 March, 2015 at 2:58 pm #

    @ Rene Doms – what is your take on the inclusion of the concept of health supplements within CAMS? Do you not think it increases the risk that dietary/food supplements will be treated as CAMS (medicines)?

    • RENE DOMS 31 March, 2015 at 5:32 pm #

      Hello Ezra
      I see no downside for the consumer if health supplements making health claims are classified as medicines. It affords the public added protection in terms of quality, safety and therapeutic efficacy. Bear in mind that the regulations governing these products are written to protect the public.

      Supplements of uncertain quality, safety and efficacy can be worse than no supplementation. It is the responsibility of government to protect patients from harm. Supplements affect the lives of people who take them. Government has the responsibility to guide and protect their citizens where they cannot protect themselves.

  35. Roy 1 April, 2015 at 3:54 pm #

    @Rene, Ezra,

    The obvious downside would be if registered “supplements” made advertising health claims which are misleading. The kinds of claims would include vague and soft suggestions like “supports” the body; “assists” a body part or system; or “helps relieve” a condition; etc.

    There also is a widespread mythology that everyone needs “antioxidants”. How is one supposed to know this? How do you know that your body is not *making* sufficient antioxidants or whether you need to take something that may or may not actually provide antioxidants?

    In addition such products might enjoy an undeserved “credibility” by being registered as “real” medicines.

    • RENE DOMS 1 April, 2015 at 4:22 pm #

      @Roy
      The Medicines Act prohibits the publication of misleading claims:

      20. Publication or distribution of false advertisements concerning medicines.—(1) No person shall—
      (a) publish or distribute or in any other manner whatsoever bring to the notice of the public or cause or permit to be published or distributed or to be so brought to the notice of the public any false or misleading advertisement concerning any medicine.

      Health supplements should not be used to treat any disease but indicated to promote wellness. Whether a supplement is really necessary in such circumstances is open to question. People however take comfort in their daily dose of vitamins. Scientific evidence to support such use is scanty.

      Real medicines are used to treat disease and taken by sick people. The credibility issue attributable to supplements does not phase me if the products are registered by the MCC and manufactured in a licensed facility. At least then the user has the assurance that the products meet a pre-approved standard.

  36. Roy 1 April, 2015 at 8:09 pm #

    @Rene

    I am confused by what seems to be confusion!

    I have yet to see Section 20 being implemented! Even Dr Rath’s misleading advertisements had to be adjudicated on in the High Court!

    I do not believe there is anything such as a “health” supplement – this is a misnomer and a myth and panders to an industry of disrepute. Are you part of that industry? What if people taking “health” supplements get damaged by taking them? Surely they should be referred to as medical / medicinal supplements if the word supplement is to be entertained. Most of them seem to be food/nutritional/ dietary supplements anyway – and people could well be better off buying FOOD.

    Please define “wellness” – it (whatever it is) is NOT promoted by “supplements”!!! [Evidence please.] Vitamins (and minerals) are already category A and so cannot be “health supplements”. “Real” medicines also diagnose and prevent disease – and are not taken only by “sick” people.

    Even if the user has the assurance that the products meet a pre-approved standard – how are they not going to be misled by false claims? (The industry’s outrageous behaviour since 2002 has shown that it has no scruples about making false claims, and cares nothing about the users except for their Rands and cents.) cGMP neither guarantees the quality of the products, nor that they will “assist”, “support”, “help relieve”, or “provide antioxidants” or whatever “substance” is believed to be beneficial. People who take money from vulnerable others because it is a “comfort” should be branded charlatans and fraudsters.

    • RENE DOMS 2 April, 2015 at 10:05 am #

      @Roy
      I agree that policing from the State has been poor regarding complementary medicines.

      The linguistic gymnastics adopted to define multivitamin, mineral and herbal preparations is unfortunate.I am not directly involved in the industry but do advise complementary medicines companies from time to time.

      As I mentioned in my previous posting, it is debatable whether these products should be consumed by healthy people. A good well-balanced diet will suffice. Wellness means the state of being free of physical or psychological disease, illness, or malfunction.In other words, these preparations are taken for comfort (wellness) as there is little solid evidence to support their use in such circumstances. This does not mean that they should or may be denied the user provided they do no harm.The choice lies with the consumer. In cases of vitamin/mineral deficiency there is a therapeutic role. Iron deficiency is a good example.

      It is true that vitamins and their combinations were called up for registration in the mid 1980’s. If a new sub-classification is created in terms of Regulation 25, it will supersede the 80’s call-up notice. So, this is not a legal hurdle.

      In writing for the general public, I try to keep my examples as simple as possible and not trip over technicalities. The law is complex.

      The pre-approved standard includes a pre-approved claim, dosage and warnings for the product.

      I cannot agree that a product meeting acceptable quality standards, correctly labelled pointing out to the user the benefits (pre-approved health claims), dosage and warnings (contra-indications, precautions, side-effects etc) are misleading or fraudulent. The consumer, in such instances is positioned to take an informed decision – there is no intention to misdirect.

      We should guard against paternalism, our duty of care does not go that far.

  37. Roy 4 April, 2015 at 9:15 am #

    @René

    I agree about the “linguistic gymnastics” – but would ascribe this directly to marketers, lawyers and vested interests.

    As you well know, Regulation 25.2 subsections 22, 23, and 24 respectively define vitamins (including “Multivitamins and multivitamins with minerals”), amino acids, and “mineral substitutes, electrolytes” as Category A medicines. Furthermore the 1985 call up of vitamins has in effect been replaced by Notice R837 of 28 October, 2014. The wording is almost identical – even in the reference to “trace elements.” The amounts specified for individual vitamins has changed. Of note is that vitamins and minerals remain “category A medicines” in “pharmacological Classifications 22, 22.1, 22.1.1, 22.1.2, 22.1.3, 22.1.4, 22.1.5 and Pharmacological Classification 32.” (Pharmacological classification 22.1.5 seemingly disappeared at least from 2003 onwards!)

    Deficiencies of these vitamins and minerals are recognised clinical entities. I am unaware of any “herbal” deficiency which has been recognised as a clinical (or subclinical) condition. (Is this not where “linguistic gymnastics” also comes in?)

    Your description of “Wellness” is entirely inadequate and does not reflect the work of pioneers in the field. This was made explicit and discussed at the first and second South African National Wellness conferences held at the Nelson Mandela Metropolitan University (NMMU)in 2000 and 2003. “Supplements” in particular do not necessarily contribute to wellness, and should not be thought of as “wellness products.”

    I reject your conflation of wellness with “comfort” – one could then include tobacco, alcohol, illicit drugs and prescription medicines, used for comfort, as “wellness products”!

    Because the law is complex, it is important to not, paternalistically, be simplistic about it. It seems to me that the more vague the definitions of “helps relieve,” “supports,” “assists,” “provides (unnecessary, unproven) substances (e.g. antioxidants); etc., are, the more the complexity of the law is distorted / undermined.

    To protect the most vulnerable (maybe even illiterate) members of our society is indeed our duty of care. There is often “cross-over” from those who choose to buy supplements for “comfort” – and can afford them; and those who choose to spend their minimal disposable income on such products because of advertising – which advertising suggests the supplements are better than food! I do not believe our duty of care extends only to educated “elites” – who may well also be ignorant and uninformed about such concepts as “detox” and “acidity” – simply because they can pay for non-beneficial products (and swell the coffers of the so-called health products industries, of which you have stated you are an occasional consultant).

    You and your colleagues seem to support *industrial* level manufacture and sale of “supplements.” It is this mass production of products having the *appearance* of medicines which I find offensive. Medicines are not considered a commodity of trade. Surely the misrepresentation of these medicines, with the sellers / manufacturers *knowing* that there is no evidence or inadequate evidence for the products, meets the meaning of fraud?

    I quote a supposedly reputable / credible source: “Fraud consists in unlawful making with the intent to defraud, a misrepresentation which causes actual prejudice or which is potentially prejudicial to another. Fraud is the crime of the liar, cheat or confidence trickster.”

    The *actual* prejudice in terms of supplements, in my view, is when a misled consumer parts with her/his money for “comfort.” The actual prejudice may also be in the “false sense of security” about their health that consumers experience because they believe, as a result of being misled, that they are doing something beneficial for their health (wellness?), by buying and taking supplements. Who are the liars, cheats and confidence tricksters involved in the supplements industry?

    Rather than a deontological (Kantian) approach, let alone invoking the legal meaning of the phrase “duty of care,” without revealing to the layperson that it is a “legal principle,” let’s go back to the principlism approach: “benefit,” “no harm,” “autonomy” and “justice.” You seem to be saying that as long as a product does no harm (except financial?), it does not matter that it has no benefit. The autonomy aspect, in my view, is dependent on full information. I have yet to see a supplement advertised as “take this for comfort – it has no benefits, but possibly doesn’t do any harm – except no-one knows for sure.”

    As an aside, I have not yet seen anything quite as paternalistic as a set of Regulations drawn up by industry and presented to the Minister of Health, as if all that is needed is his signature! I can only imagine that he would have found that insulting.

  38. RENE DOMS 5 April, 2015 at 3:59 pm #

    @Roy
    It is obvious that we have divergent world views which appear irreconcilable. I am familiar with the crime of fraud and stand by my interpretation. If a health claim is pre-approved by the regulator and labelled according to the Medicines Act and correctly made then the product is suitable for sale.

    I fail to understand what more you expect of government? If you explain what you require then perhaps we can better understand your thrust. Your policy position seems extreme to me. Are you suggesting that all these products are removed from the market? Many luxury foods are unnecessary to sustain life. Does this mean they should be banned and we resort to eating dog like pellets? Reality is missing in your approach.

    Furthermore, are you suggesting that the MCC, TGA, FDA, Health Canada and the EU are all wrong and if so why?

  39. Roy 5 April, 2015 at 7:19 pm #

    @René

    If the regulator has decided on certain health claims etc., I would of course accept that.

    My concern is those lobbyists attempting to have the regulator “soften” claims by including dubious phrases such as “helps relieve,” “supports,” “assists,” and “provides.” And even the inclusion of a vague entity called “health supplements” as complementary medicines. This is where the fraud comes in. (You’ll notice that the definition provided of “health supplement” is actually that of a food / dietary / nutritional supplement.)

    I find Timothy Egan’s Op-ed in the New York Times earlier this year revealing: http://www.nytimes.com/2015/02/06/opinion/the-politics-of-fraudulent-dietary-supplements.html?rref=collection/column/timothy-egan
    You’ll notice the word “fraudulent” in the heading.

    My concern would also be those fraudsters selling dog-like pellets disguised as luxury foods.

    The MCC’s disastrous and irresponsible 2002 “call up” has resulted in more than double the number of fraudulent products on our market [>155,000] than there are in the USA (65,000 – according to Egan’s figure). Should the majority of these products no longer be available? Most of them should probably not be available. The “applicants” did not have to provide any data in order to be placed in a database of the MCC. As you know, this was deliberately misconstrued by the industry to be permission to sell the products.

    The TGA’s listing system is failing because it does not demand evidence of efficacy (see Prof Ken Harvey’s ongoing work).

    The USA introduced the highly problematic DSHEA in 1994 – and essentially removed dietary supplements from the oversight of the FDA. See Egan’s article already referred to.

    Health Canada has recently been exposed by journalists when a fake product claiming to help children sleep, containing “nothing,” was actually approved. I can find the reference if necessary. Prof Joel Lexchin from Canada has also been outspoken against HC’s poorly regulated natural health products industry.

    The EU is, in my view, schizophrenic about especially herbal products. Bio-Strath is a good example. I can provide others.

    The issue you and I (irreconcilably?) disagree on, it seems, is that I do not believe the “supplements industry” should be making a profit from selling lies or “half-truths.” You appear to think that’s OK? The regulator is only now beginning to put a stop to that. But the lobbyists are, in response, trying to ensure that the regulator will still allow the lies in terms of “softened” health claims: “helps relieve,” “supports,” “assists,” and “provides.” A part of the industry has also, as you know, served legal papers on the Minister of Health to try and prevent their having to provide data (not vague descriptions) to the MCC.

    You ask what more I expect of Government. That is the wrong question! It is what I expect of the “health products” industries and their mass-produced non-individualised medicines, which may contain “nothing” and make spurious claims. And what I expect of those who represent these industries or consult to them, or advise them, especially those who profess (“professionals”) to have public health interests at heart, is to not promote the lies (fraud). All I see, is as Egan states: “a . . . racket . . . to the tune of $13 billion a year in sales.” Except that in South Africa, it’s about R7 billion a year, and this small country doesn’t need it to expand any further.

    • RENE DOMS 7 April, 2015 at 9:20 am #

      @Roy

      I agree with your sentiments although I express it “softly”. The Medicines Act provides remedies for fraudulent behaviour and misrepresentation.

      The various regulatory authorities, I and RDG examined have their weaknesses and why RDG put forward a set of monographs as outlined in their government submission. Those interested can read the RDG submissions to government.

      Aside, RDG is fund-less and has no corporate membership, only natural persons (human beings) are members. Contributions are from writing, editing, reviewing and publishing RDG’s views on a topic. I am a major contributor and have written all the substantive documents submitted to government so far. These documents may be distributed freely.

      The focus now turns to the regulations and the methodology that will be used to licence these medicines if the monograph system is found acceptable, if at all by the regulator. It is now their call. eCTD methodology has a major role to play and under scrutiny presently by us.

      Furthermore, our (my and RDG’s) focus now turns to Regulation 45 and its impact on the fundamental right to freedom of expression. The regulator needs to join the digital age and use the tools to inform consumers about rational drug usage amongst other aspects of medicines use.

  40. Harris 6 April, 2015 at 9:43 am #

    Rene Doms is a member (founder?) of the RDG (Regulatory Discussion Group). He has supplied me this document for posting to CamCheck. This is the RDG submission to the Medicines Control Council. The RDG represents role players involved in advising companies selling CAMS, or the actual manufacturers or distributors of these products. The document describes how the group feel CAMS should be regulated.

  41. Terry 19 July, 2015 at 8:17 am #

    This is all about control and money. It’s the first small step in the ‘totalitarian tiptoe’ to remove any competition to the medical and pharmaceutical fraternity.
    Now that the foot is in the door we will see more and more rescheduling and banning of alternative treatments under the guise that they could be harmful. What about the tens of thousands of deaths due to pharmaceuticals every year? Clinical trials are are funded and directed by the pharmaceutical companies in order to obtain a favorable outcome. Look at the Monsanto Roundup debacle. Roundup has been touted as safe enough to drink until now because safety studies were done by…Monsanto.The WHO has (very quietly) now stated that Roundup (Glyphosate) is a probable carcinogen. This is how it is with pharmaceuticals. Clinical studies on cheaper alternative medicines will ALWAYS be discredited in some way unless corporates can make a buck out of them. The explosion in complimentary medicines is a very clear indication that people want to treat themselves and reduce their exposure to (so called safe) pharmaceuticals. It is a FACT that civilians are becoming increasingly mistrustful of doctors and pharmaceutical companies.
    This is a clear violation of freedom of choice and just another way to corrupt the lives of ordinary people.

    • Harris 19 July, 2015 at 8:42 am #

      @Terry
      I thought this was more to do about whether there is proof whether the CAM is safe and has efficacy, i.e., to protect consumers from unscrupulous liars, cheats, and “corporates [making] a buck out of them”. Everyone is trying to screw money out of consumers. Do not confuse this issue with scoundrel pharmaceutical companies – because aspects of one group being ‘bad’ is not a good argument to allow another group free reign.

    • Harris 19 July, 2015 at 10:53 am #

      @Terry
      (Comment from Roy – has difficulty with his comment being accepted directly)

      Thank you for pointing out the issue of Roundup (glyphosphate) probably being carcinogenic, i.e., cancer causing.

      In South Africa, Roundup is marketed by Efekto. http://www.efekto.co.za/product-category/protection/garden-protection/garden-protection-herbicides/

      Efekto is part of Ascendis Health (“Healthy home, healthy you”) http://www.ascendis.co.za/divisions/brands/

      Ascendis owns a number of complementary medicines companies, and also at least one generic medicines (“pharmaceuticals”) brand.

      One of the complementary medicines companies owned by Ascendis is Solal: “Healthy Aging Specialists”. One of Solal’s products claims: “At low dose, I3Complex™ has a protective effect, and may reduce the risk of developing cancers. At a higher dose, it can be used as part of a treatment programme.” http://www.solal.co.za/i3complex

      So, “pharmaceutical company” Ascendis, via Efekto, on one hand sells a probable “cancer causing” agent; and on the other hand, via Solal, sells an agent to supposedly reduce the risk of cancer and even treat cancer.

      There seems to be more evidence of glyphosphate causing cancer, than there is evidence of I3Complex™ helping prevent cancer, or at high doses, being part of a treatment programme for cancer. The studies for I3Complex™ in humans are possibly non-existent, if not incomplete and insufficient.

      How can a consumer have real freedom of choice if not all the information (i.e., the lack of evidence) is made explicit?

      This is one reason why strict regulation is needed for complementary medicines – and also herbicides.

  42. Terry 19 July, 2015 at 7:48 pm #

    I agree that there should be standards and measures in place, especially when it comes to purity and getting what you are paying for. The frustration here is that strict regulation will be imposed and that will be the end of that. CAM is not and never will be treated fairly by the medical community. Here are some examples:
    No one in the scientific community is willing to fund or perform proper studies on complementary medicines for fear of ridicule or losing their job. Any studies done outside the realm of Big Pharma are written off as pseudoscience (as per your website header)
    The mountain of anecdotal evidence that a lot of CAMs are effective is staring us all in the face and yet this is routinely dismissed by anyone calling themselves a scientist. What about the common practice of off- label drug use? Off label prescriptions are based on anecdotal evidence. A few years ago my doctor casually offered to prescribe Ritalin for the chronic fatigue I was experiencing. Correct me if I am wrong but isn’t Ritalin a schedule 7 drug? No danger there.

    A large portion of modern drugs originated from plants and you can be sure that over the years many CAMs that are now laughed off as quack treatments will be quietly made into synthetic analogues, given a fancy name and sold for billions. The much maligned Cannabis plant is a perfect example of this.

    The re scheduling of CAMs to require a prescription is effectively banning them as there are very, very few doctors who will actually prescribe them because they know nothing about them.

    The Big Pharma industry is protected by an army of lawyers, connections in high places and has mountains of cash available to quietly settle medical injury claims. It’s not an issue for them. However if a herbal or ‘alternative’ medicine causes a single death or injury, everyone acts like Armageddon is upon us. Obviously one death is one too many but the negative publicity and “I told you so!” that goes on following a controversy involving CAM is completely out of proportion and often makes the front page of newspapers before any real investigation has been completed. How often does such a furore get kicked up when it’s a pharmaceutical drug? Almost never. CAMs are often made out to be dangerous and I’m sure that there are some that are potentially harmful but where is the body count? Death by pharmaceuticals is certainly not uncommon.

    My point is that CAM will never be given a fair chance. The potential of many of these medicines to heal will never be realized because of the aggressive stance taken by the medical fraternity and people like you. The way you write would give any person unfamiliar with CAM the impression that it is ALL complete nonsense (or quackery as you like to call it) and doesn’t warrant further thought or investigation. It seems that your mind is made up already or you have ulterior motives. Regulation is just an excuse to bully and persecute CAM. It is quite simply a war on the alternative health industry.

    • Harris 20 July, 2015 at 11:06 am #

      @Terry
      All CAMS will be given a fair chance if they can prove efficacy and safety.

      Contrary to your belief, “no one in the scientific community is willing to fund or perform proper studies on complementary medicines for fear of ridicule or losing their job”, there is a research going on for CAMS but the results very disappointing, hence no fanfare. See Pubmed and Natural Medicines Comprehensive Database. Yet CAM manufacturers claim efficacy even when proved to be false. This is the stuff that CAMCheck focuses on. “Anecdotal evidence” is not proof. History is littered by “anecdotal evidence” that turned out to be rubbish – even in Orthodox medicine. The only way to differentiate rubbish from valid claims is with evidence.

      Bringing up arguments of “What about the common practice of off- label drug use?” to justify your pro-CAM argument is illogical. A bad practise of Orthodox medicine does not justify any argument for CAMS. Orthodox medicine is full of bad science, corruption, etc., but most of it is evidence based – versus very little for the claims for CAMS. CAMCheck simply does not have the resources to focus on bad stuff related to Orthodox medicine – others do it better.

      Your point “herbal or ‘alternative’ medicine causes a single death or injury, everyone acts like Armageddon is upon us” is out of context. The context is that CAM proponents claims that CAMS are natural and therefore safe. Comfrey, kava kava, Ma Haung (containing ephedrine) have been shown to be toxic, only after people were hurt or killed. Some studies claims that up to 5% of people using CAMS experience side effects. Regulation would have required proof before the claim. Indeed, these products derived from natural plants were as toxic in the natural plant as they are synthesized: digitalis (foxglove), aspirin (willow and meadowsweet) and paclitaxel (Taxol) (Pacific yew).

      Your point “Big Pharma industry is protected by an army of lawyers” is contradicted by CAM manufacturers using the same tactics as Big Pharma. Ask Prof Roy Jobson, Kevin Charleston, the Dietetic Society of South Africa, and myself, who have all been threated by Solal for pointing out their lies.

    • Andrew 20 July, 2015 at 6:24 pm #

      You hit the nail on the head here Terry. Don’t expect people like Harris with clear agendas on this site and others to acknowledge any of your points though.

  43. Terry 20 July, 2015 at 7:59 pm #

    @Harris
    Most of the studies involving CAMs are small scale and few and far between, done by obscure labs all over the planet. As far as I know there are no set standards and protocols for clinical studies involving CAMs. (Correct me if I am wrong here)I suspect it is kept that way for a reason.

    The only trials that would be recognized by the medical industry are full scale randomized double blind studies. Anything less than this will without doubt be dismissed. This already puts CAMs at a severe disadvantage because the companies who make the products cannot ever hope to afford to fund full scale trials. Even if they could beg borrow or steal the funds necessary they would never be able to recoup the cost because you can’t patent a natural product and sell it for exorbitant amounts of money. This should be taken into account but I guarantee you it won’t.

    I know that anecdotal evidence is not proof and I never said it was. Anecdotal evidence is a catalyst for further investigation and there is a lot of it around. I agree that a lot of it is rubbish but there will be truths if the evidence is examined properly.

    My points about off label drug use and overreactions were not meant to try and push an agenda. I was just highlighting how the orthodox medical community and the likes of the MCC and FDA like to take the moral high ground and wag their fingers at everyone while some pretty appalling stuff is going on behind them.

    Sure the orthodox science is evidence based but the corruption and bad science negates that somewhat doesn’t it? How can we trust clinical trials and safety studies when they are funded by the very people who have a financial interest in a positive outcome?

    Anyway, I can see this is going nowhere so that will be the last from me. I do accept and agree with some of the points you make but I still believe that this is a knee jerk reaction by the MCC and hasn’t been thought through. If the legislation continues down the path that its on most CAMs will never be given a chance do good.

    • Harris 20 July, 2015 at 9:42 pm #

      @Terry
      Whether it is CAMS, orthodox medicine or other alternative forms of medicine, ALL have vested interests. The regulator’s task is meant to protect the public and create a level playing field. For example, why should evidence for the pain-reducing effect for say, paracetamol, be less than an alternative CAM? Surely the consumer expects the same degree of certainty that a claim made for pain relief for either is valid?
      ALL regulators are battling with find a solution, and none have found a perfect one.

      For me the fact is whether a product is safe and has efficacy – as a consumer, that is what I expect for myself. If one is not prepared to accept evidence from studies, how else does one know whether a product is safe and efficacious? Trust the manufacturer? Trust an ‘expert’? Both CAM and orthodox medicine have ‘experts’ that are paid to support the side paying for them.

      If you or anyone else can come up with a better system, that uses sound evidence over belief or anecdotal nonsense, then propose that to the regulators. Until then, one is left with no real alternatives. We need to find a solution to stop consumers from being duped into purchasing products with little to no benefit, and unsafe. How does one do that? How does one know whether the claims for Miracle Magnesium or a weight-loss product are valid and not bullshit? Run it through a panel of ‘experts’? Take the word of the manufacturer? How do we know that the claims are not due to a placebo response, or Hawthorn effect?

      You state: “Most of the studies involving CAMs are small scale and few and far between, done by obscure labs all over the planet”. This is true, but not the fault of it being a CAM or big clinical centers. If researchers have evaluated pilot studies and deemed the results to be too poor, or the potential benefits of the ingredient/product to be too poor, why bother to spend your limited research money on further investigation of that ingredient/product? Clinical studies conducted can be exactly the same for CAMS as for orthodox medicine, i.e., start with small pilot studies, and if the results look good, expand to larger studies. The problem with most CAM studies is that they show little benefit over placebo, hence do not progress to larger studies. Or one small study is contradicted by another study, therefore negating a positive claim.

      The fact is this: the CAMS industry so abused the consumer, throughout the world, that regulators hand has been pushed to come up with a system to prevent ongoing abuse of consumers. It does not close the door for CAMS, it simply demands evidence that the claims are supportable. The alternative to proof is belief. Belief for medicine claims is so last century, we now expect evidence.

    • Andrew 11 March, 2016 at 10:16 pm #

      These are excellent points Terry. Medicine bodies haven’t been very good when it comes to orthodox medicine now they want to come and regulate natural products and take away our choice. A case in point is the use of statins. Clinical trials showed these to be supposedly safe yet trials conducted afterwards showed them to have numerous side effects of the nature that would necessitate people to stop taking them.

      Harris could cry all he wants about anecdotal evidence and such but if it wasn’t for anecdotes we would never have been alerted to these effects or that of one of the most dangerous painkillers in history causing it to be withdrawn. In none of these cases the actual clinical trials conducted by the pharmaceutical companies were considered and doctors are in fact going only on the anecdotes.

      And while we are on the subject of statins, why do some members on panels for setting cholesterol limits have ties to pharmaceutical companies making statins? In the legal field this is a conflict of interest and any lawyer or judge in such a position would have to recuse themselves. The pharmaceutical industry should do its own housekeeping first before moving to other industries.

      Harris states: “The regulator’s task is meant to protect the public and create a level playing field.”
      “Clinical studies conducted can be exactly the same for CAMS as for orthodox medicine, i.e., start with small pilot studies, and if the results look good, expand to larger studies.”
      No they can’t. You can’t have a level playing field and impose the same conditions on both industries. The CAMS industry don’t have any exclusivity claim in abusing the consumer. Orthodox medicine is guilty of that as well if not more guilty of it. There are studies showing painkillers in children to be just as effective as sugar. It is hypocritical to ask for conclusive clinical evidence of claims. There is nothing wrong with belief in medicine as long as it doesn’t harm someone else.

      As a citizen who’s done his own research as everyone should I have a right to treatment. MMC bodies and industry shills are trying to take that right away from me.

      • Harris 14 March, 2016 at 1:34 pm #

        @Andrew
        It is unfortunate that you are so pro CAMS, that you have lost your objectivity.

        Regulatory bodies are required to protect consumers and create a level playing field. That includes the safety and efficacy of products. They do not take sides, i.e., they are not to favour Big Pharma over CAMs. If Big Pharma product x claims to be beneficial for arthritis, the same level of evidence should apply for CAM product z making the same claim. Regulators do not always get it right due to many constraints, inadequate capacity, finances, etc.

        The fact that Big Pharma or ‘orthodox’ medicines stray from a scientific process or standard is no argument in favour of CAMs. It is simply an argument against Big Pharma: they need to comply with norms and standards, as CAMS should as well.

        Your argument for numerous side effects likewise is illogical and a constant rubbish argument made by pro CAM proponents. All products, including CAMS, carry risks. In the case of Big Pharma, most products have been well studied and a health professional should inform a patient regarding the benefits and risks of using a specific product for a specific complaint/disease. In many CAM products, the risks are unknown and the product is purchased without guidance. But here is the illogical part of your argument: the more destructive the disease, usually the Big Pharma product carries a higher risk, and no comparable CAM product on offer for that disease. If there was a safer comparable beneficial product, a doctor would use it. Examples: drugs for rheumatoid arthritis, cancer, heart failure, asthma, etc. – there are no CAMS that are as effective for these conditions – but the risk of greater side effects is present.

        It is also illogical and simplistic to argue that it was anecdotal evidence that resulted in a painkiller from being withdrawn. Doctors prescribed the product to patients, patients fed back to doctors about side effects which fed back into surveillance systems set up by the regulators which resulted in further research and finally informed scientific evidence that resulted in withdrawal of the product from the market. Compare this with ephedrine, a ‘CAM’ which has killed many before the FDA could eventually take action against this ingredient.

        Your arguments against statins have merit but does not argue in favour of CAMS but against the bad aspects of Big Pharma. In fact, it supports the argument against CAMS – poorly regulated compared to Big Pharma. What is the difference between Big Pharma trying to lower cholesterol levels in order to sell statins versus CAMS that claim to be effective for cholesterol with no evidence that they work? Both actions are bad (although one could argue, that if statins work, that indeed they are beneficial versus a product that does not).

        And here is the rub: science is self-correcting. If “studies showing painkillers in children to be just as effective as sugar”, then this usually or eventually result in doctors shelving this as a treatment. Compare this with most CAMS – they will continue to be sold in spite of zero evidence.

        For every Big Pharma shill there are equivalent CAM shills. I could make an argument that you are a CAM shill. Have you ever argued against any CAMS? You will find many comments in CamCheck where I have made it absolutely clear that I am not pro Big Pharma: I am in favour of any product with adequate proof in support of the claims that product makes. If it claims to relieve a cough, it should. You on the other hand appear to argue that a CAM product can make any claim it wishes to make, without evidence. Why not extend the same right to Big Pharma?

        I stated that it is unfortunate that you are so pro CAMS, that you have lost your objectivity. I do my utmost to remain objective, using EVIDENCE to guide my position in favour, or against, both Big Pharma and CAMS. CamCheck does not have the resources to focus on all the wrongs of Big Pharma, there are other sites focussing on these.

        • Andrew 14 April, 2016 at 6:16 am #

          @Harris: Your replies here are laughable. You say I have lost all my objectivity but you are yet to show even an ounce of objectivity. You continue holding CAMs to double standards that big pharma itself fails to adhere to. If you were really serious here you would get big pharma to clean up its own act first, but you fail to get this point and see it as an argument for CAMs.

          You and I clearly have a different view here. Most of the CAMs I’ve seen do live up to their claims. If you don’t know this you haven’t really looked at the evidence and are in fact the one that’s biased here. The problem is you wanting those studies to be done by the companies themselves and it is neither feasible for them to do so nor something that’s fair to impose on them.

          Your continued claim that regulatory bodies are required to protect consumers is rubbish. They regularly act with other interests and if protecting consumers was a priority we would ban cigarettes first. But we won’t because of the backlash this would cause and the amount of lost revenue to the state. So your argument in using this as a reason why they should have a say over CAMs is a fallacy as I’ve pointed out many times. Even if it was valid they would still not have any mandate to make decisions for us.

          Likewise your argument that the worse the disease the higher the risk is rubbish. Chemical compounds have no idea and don’t care about the disease you’re treating. As we’ve seen with Vioxx a painkiller can be just as or more dangerous than cancer treatment. Likewise there are many drugs for serious conditions that carry almost no risk.

          In contrast though natural products generally carry less risks. That is actually a more valid argument but you ignore it to give big pharma a free pass for it’s high risk products. You don’t even seem to understand what anecdotal evidence is. The process you describe by which Vioxx was withdraw is exactly what’s seen as anecdotal. There was no study done to determine it unsafe. Such a study would first and foremost be unethical knowing the risks already and secondly probably illegal. The actual original studies done was actually found to be based on fabricated efficacy data.

          You ask “what is the difference between Big Pharma trying to lower cholesterol levels in order to sell statins versus CAMS that claim to be effective for cholesterol with no evidence that they work?”
          Well firstly there’s nothing to show that lowering cholesterol by using statins has any beneficial effect for heart disease. Independent meta studies have actually shown that lowering cholesterol has a slightly negative effect on heart health. The only statins that have an effect also decrease inflammation. So big pharma is actually peddling a product based on a myth. It would be hypocritical to pass this off onto CAMs for a myth that was started by big pharma. Besides for this Vitamin D has shown in numerous independent studies to have a positive effect on heart health.

          Interestingly statins function as a Vitamin D analogue but with none of the benefits and a lot more side effects. Why were these side effects not mentioned in the pharmaceutical studies only to show up in the secondary independent studies? Are you aware that big pharma does small pilot studies and participant screenings first to eliminate people that would show side effects and select people that would likely show a positive effect? If that is the system you want to impose on CAMs we neither want it nor want to pay for it.

          Why has the MCC placed an upper limit of 500IU per day on Vitamin D? I am still waiting for an answer from you on this despite having asked repeatedly. You claim that CAMs should be based on evidence but there’s nothing to support the MCC’s stance on this or numerous other products. I would like you to either provide a reasonable answer to this or admit that they are the incompetent body I know them to be before we go any further with this.

          Yeah sure you can say I’m a shill for CAMs but the fact remains you are the one continually using fallacious arguments and ignoring all evidence presented to you..

          • Harris 14 April, 2016 at 9:15 am #

            @Andrew
            I do not hold cams up to double standards, but to the same standards I would hold Big Pharma too. I did NOT say that Big Pharma complies with those standards, they often abuse these standards too. It is illogical to ask that Big Pharma clean up their act first – these are parallel processes: Both must adhere to a standard and both must clean up their acts.

            You write: “Most of the CAMs I’ve seen do live up to their claims”. I do not agree: I have really looked at the evidence, so list a few and let you and I debate your claim based on facts and evidence!

            My claim that regulatory bodies are required to protect consumers is correct. Read the sentence again. I wrote “required”. I did not say that they get it right or are not sometimes influenced, which some are. You seem to not appreciate that CAMS is a multi-billion dollar/Rand industry, and like Big Pharma, also lobby regulators.

            You write: “Likewise your argument that the worse the disease the higher the risk is rubbish. Chemical compounds have no idea and don’t care about the disease you’re treating”. I stand by my argument and you have avoided responding to my examples: drugs for rheumatoid arthritis, cancer, severe asthma, tuberculosis, HIV/AIDS, etc, all carry increased risks of side effects – there are NO effective CAMS for these conditions. Simple. If you are going to respond, give me a list of proven effective CAMS that treat these diseases. Big Pharma does not get a free pass to sell these products: the patient is informed that the ONLY effective product for a specific severe condition carries a risk, but that in x percent, the treatment is effective but carries the risk of y. Not taking the product results in the following choices with the outcome of z.

            You write: “You don’t even seem to understand what anecdotal evidence is. The process you describe by which Vioxx was withdraw is exactly what’s seen as anecdotal. There was no study done to determine it unsafe”. Your disinformation does everyone a disservice. “On Sept. 27, the data safety monitoring board for an ongoing long-term study of rofecoxib (APPROVe) recommended that the study be stopped early for safety reasons. The study showed an increased risk of cardiovascular events, including heart attack and stroke, in patients receiving rofecoxib compared with placebo, particularly those who had been taking the drug for longer than 18 months. Based on this new safety information, Merck and FDA officials met the next day, and during that meeting, the FDA was informed that Merck was voluntarily withdrawing rofecoxib from the market.” http://www.medscape.com/viewarticle/490355

            You ask: “Why has the MCC placed an upper limit of 500IU per day on Vitamin D?” I am not privy to their decisions, but they, like ALL other regulatory bodies, utilize consensus from researchers in this field of research, and come to a hopefully appropriate decision. The USA National Institutes of Health sets it at 600IU. Similarly, the European Food Safety Authority have set upper limits, based on the population groups they are concerned with. Similar for Australia. If the evidence shows that a different level is required, the limits will be changed.

            But here is the delicious irony: you are supporting an argument to achieve higher levels of Vit D – an argument that supports the argument and lobbying from companies benefiting from selling these products – and contrary to the consensus of doctors, dietitians and researchers who care greatly about protecting the health of the public. I am fully aware that the Vitamin D Council, representing sellers of Vitamin D, are arguing for a much higher level, and although their argument ‘appear’ to have validity, they can be countered.

            For us to continue this debate, I would like you to list, say, 10 CAMS that you claim “do live up to their claims”.

  44. Celia 15 December, 2015 at 4:42 pm #

    Hi there

    Would anyone be able to give me advise on how to get Goleic (GcMaf) into the country it is for personal use but worried about customs etc. do you know what it the simplest and quickest way for me to bring this in.

    I am wanting to use it for my Cancer but no one in S.A has the rights to import it but I believe they have shipped successfully to others.

    • Harris 16 December, 2015 at 8:38 am #

      @Celia
      Customs have a duty to inspect all medicines, whether registered or unregistered from entering the country.

      For readers who do not know what Goleic (GcMaf) is:
      Goleic is a product based on the concept that it is a “protein in the blood that is responsible for the mediation of the immune system. Calling this protein GcMAF (group component-specific macrophage activating factor), it was shown to activate macrophages”. Its manufacturer claims it to be effective for a long list of conditions including autism, but the claims appear to be theoretical: research appears to be ongoing.

      The use of Goleic for autism is extremely controversial and based only on anecdotal evidence. Here is an interesting article on Dr Bradstreet.

  45. Jon 14 March, 2016 at 2:13 pm #

    Harris is just an industry stooge, I wonder how much he is pocketing to voice their opinions.

    • Harris 14 March, 2016 at 2:49 pm #

      @Jon
      Sadly Jon, you display your absolute prejudice and ignorance.

      I dare you to find a single medicinal product or company that I have promoted, either on CamCheck or anywhere else. The Advertising Standards also checked after a similar complaint, and not a shred of evidence was found to support the claim.

      Because someone raises the hard truth about a scam, does not necessarily indicate the support for an opposing one. Being dead-against financial pyramid schemes, does not make one a supporter of big banking institutions. One can be against both.

      For example, if you took the care to read CamCheck properly, you will notice how I call out weight-loss scams, and often point out that even Big Pharma cannot develop an effective one.

  46. Jon 14 March, 2016 at 3:39 pm #

    The scam you refuse to see is that Big Pharma has made the rules of the drugs game so expensive that only they can play. Just as the world is realising the organic agriculture is better then chemical agriculture, so will it realise that natural medicines are better than chemical ones. Big Pharma is using the MCC to crush out all independent smaller players now so that they can continue to rape the public for profit. In 5 years from now you will find all the same CAM medicines back on the shelf, but produced by Big Pharma and costing exponentially more than they do now.

    You advocate clinical trials, but these have not proven that drugs are safe, many many drugs have made it to market and killed people before being withdrawn, clinical trials are a farce and can be made to say anything, asking the manufacturer to control the trials is like asking the rabbit to guard the lettuce patch.

    Natural medicines not only do not kill people like drugs do, they almost always have no side effects, compared to the hideous side effects of some clinically tested drugs, for which more drugs are prescribed.

    You keep mentioning weight loss scams, have you ever been into a Health Shop? Weight loss products are not the focus, if there at all. Wait till you have cancer like I had, and start finding out that doctors only peddle death to cancer patients, then, if you are smart, you will find an appreciation of CAM and heal yourself like I did.

    Why should a natural supplement have to be trialled to the same extent as a new to existence chemical that a pharmaceutical company has cooked up and wants to put in people?

    Ultimately this is political and financial, not about people’s safety, or even health. The fact that you subscribe so whole heartedly to the party line, looking only for the negatives in CAMs and ignoring far greater negatives in modern drug medicines, makes you a stooge in my book, and if you are not getting paid for it, well then….a not very bright stooge.

    • Harris 14 March, 2016 at 4:40 pm #

      @Jon
      I contrast your argument with this: “Complementary and alternative medicine such as acupuncture, herbal supplements and meditation are big business in the United States, totaling nearly $34 billion in out-of-pocket spending, according to a government report released on Thursday.” Reuters

      You wrote: “natural medicines are better than chemical ones” – not exactly true. In a few cases, possible, in the majority, not. Please furnish me with 5 examples where the proof is that the natural medicine is better than the chemical one.

      You wrote: “Big Pharma is using the MCC to crush out all independent smaller players”. Not true. Both Big Pharma and CAM companies, e.g., HPA, lobby the MCC. The MCC is tasked with asking for evidence. In fact, right now it is far easier for CAM products in certain disciplines to be registered with the MCC than Big Pharma. For example, for some homeopathic products, all you need to do is prove is was used for the last 100-200 years or so to be registered, no clinical studies required!

      You wrote: “rape the public for profit”. Both Big Pharma AND CAMS are no different. Both are in it for profit. Some vitamin or other preparations sold by CAM sellers are more expensive than some drugs sold by Big Pharma.

      You wrote: “You advocate clinical trials, but these have not proven that drugs are safe . . .” Clinical trials do not prove that products are safe. They demonstrate the range of side effects possible, and if not severely risky, and depending on what they are being used for, may get registration. If a disease kills 100% of people, and a drug can save 80% but with the risk of severe side-effects, it may still gain registration. But if 0.5% of people get a severe reaction, one has to study over 200 people before this becomes evident. So penicillin causes anaphylaxis in 1-5 per 10 000 cases of penicillin therapy. That means that a large clinical trial may not have cases of anaphylaxis, but when thousands to millions of people start using the product, that these reactions become evident.

      I am sorry to hear that you had cancer. But here is the rub. There are NO natural products that have been shown to cure cancer. Not one. Sad but true. Where people claim to have been cured does not hold up to scrutiny, may be due to the cancer naturally regressing, coincidental with another well proven treatment, etc. I wish there was a natural (and cheap) cure, but I and all the doctors I work with, will welcome it! I worked for 2 years in a children’s cancer ward, and I can guarantee every one of the doctors working in that unit, would have grabbed with both arms, ANY natural product that worked.

      You write: “. . looking only for the negatives in CAMs and ignoring far greater negatives in modern drug medicines . . “. Wrong again, I look very hard for positives in CAMS. They are just damn incredibly rare! And I repeat what I wrote two comments ago: “CamCheck does not have the resources to focus on all the wrongs of Big Pharma, there are other sites focussing on these.” Bad Pharma by Ben Goldacre and Doctoring Data: How to sort out medical advice from medical nonsense, by Malcolm Kendrick, both document the very wrong stuff that Big Pharma is capable of.

  47. Alex 1 September, 2017 at 8:45 am #

    Hello, I am hoping for some guidance. I would like to make a horse supplement out of 3 ingredients readily available off the shelves of many stores, Namely Glucosamine, MSM and Chrondorin Sulphate. Is there anything I need to do/ register to legally be allowed to sell it? thanks

  48. amanda 6 September, 2017 at 9:42 pm #

    Please there is a company that has being illegally importing more than 30 complimentary medicines into south africa and marketing them to the general public without any approval from MCC or any authority .How can one get the law enforcement agencies and the regulatory agencies to deal with this company and hold the perpetrators to account.

    • Harris 7 September, 2017 at 7:55 am #

      @Amanda
      Unfortunately the authorities are doing nothing about policing or enforcing this industry. Very depressing. That does not mean you should not lay a complaint with the MCC, or even the NCC (National Consumer Commission). They may suddenly start doing something positive. An alternative idea is to try to get a consumer reporter such as Wendy Knowler of the Times to write about this. Could you let me know what company and products you are referring to?

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