Vigro – balderdash!

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Posted 05 July 2013

The ASA has previously ruled against the claims for Vigro. We had argued that preventing or curing hair loss would be a “holy grail” and on face value, the claims are impossible. Vigro’s expert, Mr John Knowlton, argued that the science in support of Vigro’s claims are valid for individuals who are affected by a specific form of hair loss and not all forms of hairloss. The product Vigro has subsequently been sold to Natura, a manufacturer of homeopathic products, and they are now aggressively marketing this product as being effective for hair loss.

Here we examine the ingredients and the “proof” supplied by Mr Knowles and the manufacturer, and show that the evidence in favour of this product working in ANY form of hairloss, is in fact balderdash.  A new complaint has been laid with the ASA.

Advertising Standards Authority of South Africa
Box 41555
Craighall 2024

Dear Sir or Madam,

Re: VIGRO

Vigro makes a number of unsubstantiated claims that I argue are misleading to the ordinary consumer.

These are:

At http://www.vigro.co.za/

Try the Vigro 3-step programme – an effective long lasting solution to thinning hair.

The Vigro® system supports your scalp to re-activate hair growth and thereby helping to maintain the natural balance of hair loss and growth. Note: the Vigro range is not effective against hereditary hair loss

 

At http://www.vigrohair.co.za/treatment.asp?step=Step%202 [no longer active] – see http://www.vigro.co.za/

Vigro® Bio-Tonic is a clear, greaseless leave-in tonic with the active ingredient Follicusan™ – shown to assist the scalp in counteracting non – hereditary abnormal hair loss, by helping to reactivate hair cells to promote new hair growth, as well as helping to strengthen weakened hair follicles.

 

If required, you can use Vigro® Bio-Conditioner – a leave-on conditioner with Biotin Complex that assists the scalp to guard against hair loss, promote thicker and to help guard against premature hair loss, promote thicker and stronger hair, as well as providing exceptional nourishment to detangle and smooth your hair.

 

If required, you can use Vigro® Bio-Conditioner – a leave-on conditioner with Biotin Complex that assists the scalp to guard against hair loss, promote thicker and stronger hair, as well as providing exceptional nourishment to detangle and smooth your hair.

 

At http://www.vigrohair.co.za/treatment.asp?step=Step%203  [no longer active] – see http://www.vigro.co.za/3-step-system/

Vigro® Bio-Capsules are a nutritional supplement containing a combination of vitamins and minerals essential for healthy hair growth to help effectively promote healthy hair growth from the inside.

 

Alternatively you can take the Vigro® Plus Bio-Capsules with added Lycopene, an anti-oxidant that can assist to prevent oxidative damage to the hair follicles.

 

I argue that the text in italics cannot be substantiated for there is no proof that Vigro assists any form of hair loss, including hereditary hair loss as claimed in a few sections of the website.

On 16 May 2012 the ASA ruled in my favour (mostly) against the claims being made for Vigro. The company appealed and on the 3rd October 2012, the ASC considered Vigro’s appeal and ruled in favour of the company (VIGRO / HA STEINMAN / 19196).

 

I had argued in my complaint that Vigro has no proof of efficacy for hair loss and by implication, both genetic and non-genetic hair loss. The ASA considered Vigro’s evidence and correctly ruled that the evidence was insufficient. Vigro partially appealed that ruling. The ASC considered Vigro’s appeal where they argued that their substantiators evidence was sufficient to satisfy the claims for non-hereditary hair loss. As per my original complaint, I argued that I could find no evidence for efficacy of Vigro for any form of hair loss. It is apparent from the ruling that my scientific argument to show that Vigro’s substantiators substantiation was inadequate was not considered and that the ASC felt that I had not supported my argument with that of an expert – contrary to the ASA code for this is not required in an appeal. I therefore requested arbitration as per ASA regulations for I argued that consumers were being mislead for Vigro’s claims have absolutely no evidence to support the said claims.

 

However I am informed that Vigro has undergone a change of ownership and that the previous ASC ruling in favour of Vigro (VIGRO / HA STEINMAN / 19196) falls away and hence arbitration that I requested cannot proceed, and that a new complaint has to be laid against the claims for this product.

 

As my arguments against the claims for Vigro are essentially the same as reflected in my request for arbitration request, I am essentially resubmitting them here. And considering that Vigro is bound to submit the same argument as previously, I need to reflect my counterpoint here for although they appear out of context in this submission, they will be relevant for the respondent’s response. I am also submitting an assessment by an expert, Prof. Roy Jobson. Prof Jobson is a professor of Pharmacology and hence has applied his expertise as an expert in evaluating scientific therapeutic claims.

 

Although Vigro makes a quasi-legal argument that “’product-specific substantiation’ requirement is misinterpreted”, or the alternatives, I want to call into question ALL the claims for Vigro including the adequacy of the “credible experts”, Ms Alison Vienings and Mr John Knowlton. I will be arguing that not only is there NO “product-specific substantiation” in support for the product, but that in fact, there is also no “ingredient-specific substantiation” either!

 

In Vigro’s appeal they argued that the ingredients in their product are effective in a subset of individuals with hair-loss. It Is however clear from my evidence below that the claims for this product are not supported, and I can show very clearly that Vigro’s “credible experts” have NOT applied their minds, nor used due diligence in the process of evaluating the evidence. This will become clear in discussing the said evidence.

 

Furthermore, Vigro argues that international standards should be applicable to Vigro and supplies substantial documentation to support that this product is a cosmetic, yet they themselves submitted an application for registration of the “product” as a complementary medicine in South Africa. Ms Vienings writes that “should the Regulator consider the Vigro range of products for topical use to be complementary medicines (rather than cosmetics) the studies conducted with the Follicusan active principle would be acceptable to support the claim for the stimulation of hair growth and prevention of hair loss for the products.” She gives no evidence that the Regulator would in fact accept the studies as adequate and instead implies that the Regulator is contemplating using the Australian registration system. She then quotes an April 2011 Australian “guideline” which makes reference to “other Listable medicines.” International guidelines should only be a last resort for substantiation when there is no local information and I am of the view that this reference to “international information” does not apply in this case, and that local regulatory thinking must trump any so-called “substantiation requirements world-wide.”

 

The phrase “Listable medicines” does not even appear in the August 2011 MCC Guidelines on “Complementary Medicines – Quality, Safety and Efficacy” and I can find no evidence for Ms Vienings’ statement that the draft regulations “clearly” show the Regulator’s intent to follow the Australian TGA process for the registration of complementary medicines. The draft general Regulations to the Medicines Act (as opposed to guidelines) gazetted for comment in July 2011 would not even include Vigro as a complementary medicine! The proposed definition of a complementary medicine in the proposed draft regulations is:

 

“complementary medicine” means a medicine that is used-

(a) or intended to be used for, or manufactured or sold for use in assisting the innate healing power of a human being or animal; and

(b) in accordance with the practice of the professions regulated under the Allied Health Professions Act, 1982 (Act No. 63 of 1982).

 

Furthermore the Medicines and Related Substances Amendment Bill 2012 incorporates cosmetics into a proposed South African Health Products Regulatory Authority. The Bill defines cosmetics as:

‘cosmetic’ means a cosmetic as defined in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972),

The definition of a cosmetic in the Foodstuffs, Cosmetics and Disinfectants Amendment Act, 2007 (which has been assented to by the President) is:

‘cosmetic’ means any article_, preparation_ or substance (except a _medicine_ as defined in the Medicines and Related Substances_ Act, 1965 (Act 101 of 1965)) intended to be rubbed, poured, sprinkled or sprayed on or otherwise applied to the human body, _including the epidermis, hair, teeth, mucous membranes of the oral cavity, lips and external genital organs,_ for purposes of cleansing, _perfuming, correcting body odours, conditioning, beautifying, _protecting,_ promoting attractiveness or improving or altering the appearance and includes any part or ingredient of any such article or substance.” (emphasis added) [I am not sure if the amendment Act has yet been promulgated.]

 

The July 2011 draft general Regulations to the Medicines Act propose a category of medicines to be referred to as complementary medicines in Regulation 25. These would become Category D medicines. A new regulation “DISCIPLINES OF COMPLEMENTARY MEDICINES is inserted which states:

“25A. Medicines in category D are subdivided into such disciplines as may be determined by the Council after consultation with the Allied Health Professions Council of South Africa.”

 

I think it is extraordinarily presumptuous of Ms Vienings (in her point 4.3) to predict that should the Regulator consider the Vigro range of products for topical use to be complementary medicines (rather than cosmetics) the studies conducted with the Follicusan active principle would be acceptable to support the claim for the stimulation of hair growth and prevention of hair loss for the products. There is no evidence to support that the Regulator would accept these studies. Indeed the latest draft Regulations and draft guidelines appear to, in my view, correctly take an approach more consistent with the existing requirements for ensuring the quality, safety and efficacy of (any) medicines.

 

What I am trying to demonstrate is that it appears that the intention of parliament and the Regulatory authority is to consider cosmetics to be medicines subject to the Medicines Act and that any historical considerations of the use of the Australian system, admittedly once considered, no longer apply.

 

I would also like to point out that in Ms Vienings substantiation (point 3.1) states:

 

“Follicusan contains biologically active signaling proteins, ethyl panthenol (provitamin B5), inositol as well as cysteine and acetyl methionine, in a water-alcohol medium. The product revitalizes the cells of the scalp.” However, according to the Vigro documentation Follicusan contains not “cysteine” as listed above – but “acetyl cysteine”. As Ms Vienings would well know, acetyl cysteine is a Schedule 2 substance which may not be advertised to the general public. I cannot tell if she deliberately left out this information or not. However, it does mean that in terms of Regulation 45.2(b) of the Regulations to the Medicines Act, Vigro (or Follicusan) should not be advertised to the public. This should have been pointed out by Ms Vienings in her substantiation particularly as she is claiming the product to be a medicine and not a cosmetic. I’d contend, in apparent agreement with Ms Vienings, that because an application for registration as a medicine has been made in terms of the complementary medicines call up of 2002, the product must abide by the provisions of the Medicines Act.

 

As far as Mr Knowlton’s substantiation is concerned, I must take issue with his assertion that “Even in the case of generic drugs, once the efficacy of a dose form has been clinically substantiated, it is commonly accepted that the drug will be effective in a wide variety of excipients and delivery systems, provided that there is no scientific reason to believe that the excipient design, or delivery system, would positively or negatively affect the proven efficacy of the drug.”

 

This is contradicted by the MCC guidelines on “biostudies” for the registration of generic medicines, where it is clearly stated:

 

“4 Topical products

 

4.4 TOPICAL PRODUCTS

Pharmaceutically equivalent topical products prepared as aqueous solutions containing the same active pharmaceutical ingredient(s) in the same molar concentration and essentially the same excipients in comparable concentrations are considered to be equivalent without the need for further documentation.

 

It is incumbent upon the applicant to demonstrate in the dossier (not in the BE report) that the excipients in the pharmaceutically equivalent product are essentially the same and in comparable concentrations as those in the reference product.  In the event that this information about the reference product cannot be provided by the applicant, it is incumbent upon the applicant to perform in vivo or in vitro studies to demonstrate that the differences in excipients do not affect product performance.”

 

My understanding of what this means is that in this situation, unless Vigro can show “pharmaceutical equivalence,” it would be incumbent to perform studies to demonstrate that the differences in excipients do not affect product performance. None of the information provided in the substantiation received from Ms Vienings, Mr Knowlton or Mr Vos shows this.

 

Apart from the above deficiencies in the substantiation provided, I will also address the actual studies referred to. In my view, the studies are completely inadequate as will be expanded on below.

 

 

In addition to this information, I bring the following facts to the arbitrator which will indicate the paucity and illogical arguments brought in support of the claims for the product.

 

I evaluate three critical questions:

  1. What is the evidence for Vigro that it will have any effect on hair loss?
  2. What is the evidence for Follicusan™, the major “ingredient” in Vigro, that it will have any effect on hair loss?
  3. What is the evidence for the individual ingredients in Follicusan™, on hair loss?

 

Sources of evidence for the claims of Vigro and Follicusan

Despite my criticism of Ms Vienings’ interpretative and other skills, I’m sure she will vouch for two major sources of accurate scientific information:

  1. Pubmed (PubMed comprises more than 21 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.)http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed
  2. Natural Medicines Comprehensive Database (NMCD) (“Unbiased, Scientific Clinical Information on Complementary, Alternative, and Integrative Therapies”) http://naturaldatabase.therapeuticresearch.com/

 

  1. Studies for the efficacy of Vigro

Vigro claims: “Vigro® Bio-Tonic is a clear, greaseless leave-in tonic with the breakthrough ingredient Follicusan™ – shown to have a 90% success rate in counteracting abnormal hair loss, by reactivating hair cells to promote new hair growth, as well as helping to strengthen weakened hair follicles.”

 

However, there is not a single study demonstrating the efficacy of Vigro published in peer-reviewed journals, or reviewed in a peer-reviewed manner, in support of these claims. In other words, no evidence, only thumb suck.

 

  1. Studies for the efficacy of Follicusan®, the prime ingredient in Vigro bio-tonic for which the said claims are being made.
    1. There is not a single study published in the peer-reviewed literature demonstrating the efficacy for Follicusan® (Follicusan® is actually a mix of ingredients).
    2. Searching both Pubmed and NMCD for any evidence for research on Follicusan™ finds not a single document.
    3. In fact, the ONLY evidence in support of Follucisan® has been in studies conducted by the manufacturers themselves. These studies are clearly not independent and have not been independently reproduced. Note: Mr Knowles claims that they are independent, but according to my data checking, they were conducted by the manufacturers. It is possible that Mr Knowles may be able to assess studies adequately, but there is no way of him knowing whether the original studies conducted by the manufacturers are in fact true – they have not been independently reproduced.
    4. Mr Knowlton submits three studies to support his argument that Follicusan has efficacy. I have been able to independently only corroborate one:Note:
      The studies (deconstructed below) were conducted with a 5% Follicusan gel comprising 5% Follicusan and the remaining 95% comprising Simulgel EG, Water, distilled, Ethanol 96 % v/v, and Polyglycol 400.

 

Vigro on the other hand consists of Follicusan and the remaining ingredients comprise: Water (Aqua), Alcohol Denat., Polysorbate 20, Ammonium Carbonate, Propylene Glycol, PEG-5 Stearyl Ammonium Lactate, Ethoxydiglycol, Panthenol, Polysorbate 80, Ammonium Hydroxide, Allontoin, Hydrolyzed Collagen, Butylene Glycol, Inositol, Panthenyl Ethyl Ether, Allium Sativum Extract, Nasturtium Officinale Extract, Lamium Album Extract, PinusSylvestris Extract, ArctiumLappa Root Extract, AnthemisNobilis Flower Extract, RosmarinusOfficinalis Leaf Extract, Hedera Helix Extract. Arnica Montana Flower Extract, Sulfur, Acetyl Cysteine. Acetyl Methionine, Lactose, LactusProteinurn, Sodium Citrate, Citric Acid, Parfum, Benzil Salicylate, Hexyl Cinnamal, Nettle, Watercress, White Nettle, Pine Cone, Burdock, Chamomile, Rosemary, Ivy, Garlic, Arnica. (emphasis added)

 

Vigro also incorporates a “bio-shampoo” and some “bio-capsules” – and the studies do not test the whole “Vigro” system – they must therefore “ipso facto” be considered insufficient.

 

It would seem somewhat extraordinary to claim that these additional ingredients and products had NO effect whatsoever on Follicusan. Alternatively, there is simply not a shred of evidence, except an “opinion”, that these extra ingredients have absolutely no effect.

 

I.        Study 1
“11.1. A scientific in vitro study on “The Stimulation of the Synthesis of Base membrane Constituents” in dermal papilla cells, provided by the manufacturer of the active ingredients used in the Vigro product range”

Comment: This is not a human trial and has no relevance.

 

II.        Study 2
“11.2. An independent scientific in vivo study (10 human volunteers, over a three month period) on the application of a hair care preparation containing the active ingredient used in the Vigro product range”

 

Comment: This study was not independent but conducted by the manufacturers. This “study” presented as an abstract at a congress and therefore not peer reviewed. Nonetheless the data is relevant for it conflicts with the claims for Follicusan®.

 

“Only 10 female and male volunteers suffering from androgenetic and diffuse alopecia were studies applying a 5% Follicusan® gel preparation applied once a day on the scalp for a period of 3 to 4 months. The conclusions were that in female volunteers with a diffuse hairloss, a significant decrease of telogen hairs were observed, accompinied [sic] by a moderate increase of anagen hairs. But also in volunteers with androgenetic alopecia, a moderate reduction of telogen hairs could be observed. According to these results, Follucisan® showed the best effects in women with diffuse loss of hair.”(Appendix B)

 

From Vigro’s own submission:

For men: “Out of the 4 response cases, 2 showed a slight and 2 a distinct decrease in telogen hair”, and for women: “In contrast, out of the 5 female volunteers 3 were found to show a distinct and 2 a slight decrease in the telogen rate. Simultaneously, 4 female volunteers showed a slight and 1 a distinct increase in anagen (growing) hair” after applying the gel for 3-4 months!

 

Comment:

In other words, Follicusan® on its own without being added to extra ingredients or excipients does not appear to have after application for a period of 3-4 months, a significant effect on male hair-loss (androgenetic and diffuse alopecia), and a slightly better effect on women. And most importantly, extrapolating evidence from an un-independent study of 5 women (of which not all benefit significantly) to ALL individuals, including men, is contrary to even basic scientific practise which impacts on the credibility of the “credible experts”

 

 

III.        Study 3
“11.3. An independent scientific in vivo study (29 human volunteers, over a six month period) on the application of a hair care preparation containing the active ingredient used in the Vigro product range and its effect on Cumulated Hair Thickness and Density in subjects affected by Androgenetic Alopecia (AGA).”

 

Mr Knowlton concludes: “. . . .it is the 29 subject in vivo human volunteer study that provides the most compelling evidence for the substantiation of the claims being made by PSN Brands (Pty) Ltd. in the marketing of its Vigro range., In this study, a topically applied hair preparation containing 5.0% Follicusan™ demonstrated that hair density, cumulated hair thickness and terminal hair density did not suffer significant change over a 6 month period, in subjects suffering from Androgenetic Alopecia . . .”

 

Comment:

Actually the study group consisted ONLY of females (29) of which only 24 completed the study. As indicated above, men and women’s hair-loss are not similar and a study on women cannot be extrapolated to men. The study concluded after 6 months. The study concluded: “The results obtained in the present observational study showed that topically applied CLR-05 used by female patients with moderate androgenetic alopecia over a period of 6 months prevented the androgenetic alopecia from progressing. Hair density and terminal hair density as well as cumulated hair thickness did not change.” In other words, at best, hair-loss was simply stopped.

 

 

A review of Mr Knowlton’s three studies show very clearly that the data is insufficient to extrapolate to millions of individuals who do not match the study group, nor the treatment. Indeed, the data is shocking and shows no evidence in support of Vigro’s claims.

 

 

  1. Studies for the efficacy of the ingredients in Follucisan®

Vigro claims: “Vigro® Bio-Tonic is a clear, greaseless leave-in tonic with the breakthrough ingredient Follicusan™ – shown to have a 90% success rate in counteracting abnormal hair loss, by reactivating hair cells to promote new hair growth, as well as helping to strengthen weakened hair follicles.”

 

On the manufacturer’s website, for Follicusan™, it states:

 

Follicusan™ contains:

biologically active signaling proteins,

ethylpanthenol (provitamin B5),

inositol,

acetyl cysteine

acetyl methionine, in a water-alcohol medium.

(emphasis added)

The product vitalizes the cells of the scalp, including the hair follicles, and thus counteracts premature, accelerated hair loss (alopecia).

 

Another description of the ingredients in Follicusan® (Chemlishes Laboratorium Dr. Kurt Richter GmbH) is described as “is composed of a fraction derived from milk, ethyl pantenol, inositol and sulfur-containing amino acids (N-acetylcysteine and N-acetyl methionine in an aqueous alcoholic medium.” (emphasis added) http://www.faqs.org/patents/app/20090111881

 

However: the International Nomenclature of Cosmetic Ingredients (INCI) is a system required by various countries in order to display accurate information on labels of cosmetic products. INCI names are the “true” names of the ingredients and devoid of the marketing hype. The INCI system allows the consumer to identify the ingredient content. It is required under the law to have the INCI name for ingredients on cosmetics and personal care items in Canada, the USA, Japan, the EU and many other countries. And INCI names often differ greatly from systematic chemical nomenclature or from more common trivial names and more accurately reflect the actual contents of the product. (http://en.wikipedia.org/wiki/International_Nomenclature_of_Cosmetic_Ingredients)

 

Therefore, evaluating the true ingredient names, and the evidence for efficacy for these ingredients in lieu of the claims of efficacy (“ingredient-specific substantiation”), is in order.

 

The correct names for the ingredients of Follicusan™ found in Vigro is supplied in Annexure PSN 1 Reference 2.pdf.

 

These are:

INCI Name:

  • Water
  • Alcohol Denat.
  • Panthenyl Ethyl Ether*
  • Milk Protein
  • Lactose
  • Inositol
  • Acetyl Cysteine
  • Acetyl Methionine**
  • Sodium Citrate
  • Citric Acid

(emphasis added)

http://www.coptis.com/Download/COPTIS%20INGREDIENTS/Library/1CLR_SOCI_EN.pdf

 

*Panthenyl Ethyl Ether = ethyl panthenol (provitamin B5)

**Acetyl Methionine = Function/use(s): Skin-conditioning agent – Miscellaneous; skin conditioning Acetyl Methionine is a substituted amino acid.

 

The ingredients, water, alcohol, milk protein, lactose (a sugar found in milk), sodium citrate and citric acid, are self-evident.

 

A search of NMCD for any evidence for ANY effect on hair in human subject’s for the individual ingredients listed in INCI resulted in not a single reference. I include the data on the three major functional ingredients in Follicusan to illustrate this.

 

Similarly, a search of Pubmed for any evidence for ANY effect on hair in human subject’s for the individual ingredients listed in INCI resulted in not a single reference with one exception, that for panthenol. However, the study is not relevant in this instance. (Appendix A)

 

However:

Vigro claims that this product’s claims are substantiated based on the evidence for Follicusan, which I show above, is in fact insufficient evidence. But in addition to Follicusan, Vigro has added their own list of ingredients:

BIO-TONIC INGREDIENTS:

Water (Aqua), Alcohol Denat., Polysorbate 20, Ammonium Carbonate, Propylene Glycol,PEG-5 Stearyl Ammonium Lactate, Ethoxydiglycol, Panthenol, Polysorbate 80, Ammonium Hydroxide, Allontoin, Hydrolyzed Collagen, Butylene Glycol, Inositol, Panthenyl Ethyl Ether, Allium Sativum Extract, Nasturtium Officinale Extract, Lamium Album Extract, PinusSylvestris Extract, ArctiumLappa Root Extract, AnthemisNobilis Flower Extract, RosmarinusOfficinalis Leaf Extract, Hedera Helix Extract. Arnica Montana Flower Extract, Sulfur, Acetyl Cysteine. Acetyl Methionine, Lactose, LactusProteinurn, Sodium Citrate, Citric Acid, Parfum, Benzil Salicylate, Hexyl Cinnamal.

FOLLICUSAN™

Water (Aqua), Alcohol Denat. Panthenyl Ethyl Ether, Inositol, Milk Protein, Lactose, Acetyl Cysteine, Acetyl Methionine, Sodium Citrate, Citric Acid. (emphasis added)

BOTANICAL EXTRACTS

Nettle, Watercress, White Nettle, Pine Cone, Burdock, Chamomile, Rosemary, Ivy, Garlic.Arnica.

 

 

Vigro wants the ASA to believe that they can add approximately 35 additional untested ingredients in hair loss and reasonably expect us to believe that they are all synergistic and augment Follicusan? This is unscientific and not defensible. It does not follow any scientific principles of pharmacology or any therapeutic principle. This is purely an illustration of untested alchemy. (Mr Knowlton’s analogy of an air filter for a motor car is simplistic and inappropriate.)

 

I argue that the burden of proof must require product-specific substantiation. Even if the ASA had to consider ingredient-specific substantiation, which I point out has been abused previously, Vigro submits a document from the Australian TGA titled “Guidelines for levels and kinds of evidence to support indications and claims For Non-Registerable Medicines, including Complementary Medicines, and other Listable Medicines” (Annexure PSN 1 Reference 4.pdf) which in fact also supports my argument that the claims for this product are invalid. I refer the ASA to the following statements in that document:

 

  • “All indications and claims made about therapeutic goods must be capable of substantiation – that is, evidence must be held by sponsors which demonstrates the indications and claims are true, valid and not misleading.”

 

  • “Ideally, the studies relied on by a sponsor would be largely consistent with the surrounding body of evidence. Wide variation in outcomes of studies and inconsistent or conflicting results will raise serious questions about the adequacy of a sponsor’s substantiation.”

 

  • “A common problem in substantiation of claims is that a sponsor has valid studies, but the studies do not support the claims intended to be made.”

 

  • “In drafting indications and claims, the sponsor should take care to make sure that they match the underlying evidence support. Indications and claims that do not match the science, no matter how sound that science is, are likely to be unsubstantiated.”

 

  • “Sponsors should provide evidence that the profile of the active ingredient(s) extracted using different manufacturing processes and solvents is not substantially different from the extract used in the clinical studies or other evidence used to support the claim.” Note: Evidence, not an opinion!

 

  • “For multi-component Listable products, indications and claims can be based on the evidence for the product itself, or on evidence for an individual component or components about which indications and claims are made. In any instance where a claim links the presence of an ingredient to the product indication or claim, that ingredient must contribute to that indication or claim. Where claims of synergy are made, the evidence must support the synergistic effect. “

 

  • “However, if the efficacy of the product as a whole had not been evaluated, the product could carry indications / claims about the potential value of each of its ingredients. For example (in a Liver Tonic example), B-vitamins are important for a healthy liver, and studies have shown that silymarin is of benefit in helping the liver to recover from the toxic overload of everyday life.”

 

It is clear that Vigro fails this basic requirement.

 

 

Regarding the evidence for pure Follucisan® (before being reformulated into other products).

 

Mr Knowlton argues that the excipients could not impact on efficacy, but no evidence is supplied. The manufacturers themselves have indicated that additional ingredients may impact efficacy.

  • The manufacturers specifically point out that “[W]ithin the pH range 3.5 to 5.5 the proteins in Follicusan may precipitate, therefore when formulating with Follicusan this pH range should be avoided. http://bkcosmeticsadd.wordpress.com/tag/follicusan/
    • Furthermore, there are numerous scientific and pharmaceutical examples where a combination of ingredients has either resulted in antagonistic or synergistic effects. For example, adding components of tea with vitamin C and iron, results in the former two inhibiting the absorption of iron in humans.

 

Therefore, it is critical that the product as a whole (product specific substantiation) needs to be implemented.

 

 

Conclusion

It is therefore my opinion, that the evidence for the claims for Vigro as being beneficial in a subset of alopecic patients, in particular as a result of the main component, Follicusan, is either non-existent, extremely weak or inappropriate. It is also clear that this product requires full registration with the Medicines Control Council before being marketed to consumers.

 

It also gives a clear indication why product-specific substantiation is so critical in protecting consumers and preventing misleading claims – a mandate of the ASA.

 

It also demonstrates that substantiation of so called “credible-experts” should be not be taken at face value.

 

Sincerely,

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2 Responses to Vigro – balderdash!

  1. Lizette 29 August, 2020 at 9:05 am #

    What are the ingredients of the bio capsules and bio plus capsules? Which contraindications and/or drug interactions exist with the use of vigor capsules?

    • Harris 30 August, 2020 at 7:53 am #

      @Lizette
      You will need to contact the manufacturers. Basically nothing special in the capsules that are not present in other products.

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