Posted 10 October 2013
Consumers have a right to expect reasonable proof that a product delivers on its claims.
Natura, the maker of “famous” homeopathic remedies, purchased the Vigro product from PSN Brands, and ignoring the previous ASA ruling which found that Vigro was only beneficial for a very specific form of hair loss, started advertising that it was effective for all hair loss (makes one wonder about their ethics). A request that we made to the ASA for arbitration against the initial ruling, arguing that Vigro was completely ineffective, could therefore not proceed. However, it did allow a new complaint to be laid with the ASA arguing again that Vigro is ineffective for all forms of hair loss.
Natura brought in three “experts” to support their claim: Dr David Nye, Allison Vienings, and Mr John Knowlton. As one will see on CamCheck, Allison Vienings of MRA Regulatory Consultants has a long history of substantiating products that have little to no evidence to support their claims. We have been highly critical of Dr David Nye, a homeopath, who has recently also been called in to substantiate products with limited to no evidence. Mr Knowlton, a cosmetic scientist (Cosmetic Solutions) has also been called in to substantiate a range of cosmetic products – and poorly in our opinion (see the Glomail Celltone ruling just out which supports our claim).
In our argument, we simply stuck to the evidence and the facts, asking the simple question: “does the evidence support the claims?” We argued “no”, and the ASA, in reviewing the arguments, agreed with us.
Result: Insufficient supporting evidence for the claims = Vigro may not make claims that it is beneficial for reversing hair loss.
This posting is in a number parts:
1. The ASA ruling
2. Our argument why the evidence for Vigro just simply did not stack up – using Vigro’s own evidence supplied!
3. Dr Nye’s substantiation [opens in new window]
4. Mr Knowlton’s substantiation [opens in new window]
[spoiler title=”Any scientific proof?” style=”fancy”]Mr Knowles claims that Vigro works, in particular because of the ingredient Follcusan. What is the up to date scientific evidence of any benefits for any treatments? Reviews show that ALL treatments available – Big Pharma and Complementary Medicine – have very poor results. Vigro and Follcusan are not even mentioned. Makes you think!
Recent review: Female pattern alopecia: current perspectives
01 Oct 2013
In the matter Vigro / HA Steinman / 19196 (16 May 2012), the Directorate upheld a complaint against claims made for the Vigro 3 step programme. The Directorate ruled that the website was unclear in stating that the product would only work on people who were not exhibiting signs of hereditary hair loss. The respondent at the time (PSN Brands) subsequently appealed the ruling to the ASC (Advertising Standards Committee). The ASC ruled that “The Committee did not find it necessary to decide whether ingredients specific substantiation is sufficient as it was satisfied that the experts [sic] opinions covered product specific substantiation in so far it relates to non genetic hair loss.”
The appeal succeeded and the complainant subsequently requested for the matter to be referred to arbitration.
The Directorate was then informed that PSN Brands had sold Vigro to Nativa (Pty) Ltd. The complainant lodged a new complaint given that the product was under new ownership. The complaint specifically related to online advertising for Vigro on the link http://www.vigrohair.co.za/index.asp
When the link is accessed the following information is displayed:
“DO YOU LOSE MORE THAN 100 HAIRS A DAY?
Try the Vigro 3-step programme- an effective long lasting solution to thinning hair.”
It then lists the products within the range namely, Vigro Bio-Tonic, Vigro Bio-Activator leave on cream and Vigro Bio Conditioner with a description of the products properties.
The complainant took issue with the following claims:
• “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.”
• “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.”
• “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.”
He argued that there is no proof that the products assist any form of hair loss, including hereditary hair loss.
RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
In light of the complaint the following clauses of the Code were taken into account:
• Section II, Clause 4.1 – Substantiation
• Section II, Clause 4.2.1 – Misleading claims
Stefan Vos Marketing Regulation Advisers, on behalf of the respondent, submitted that the substantiation is materially the same as previously submitted by PSN Brands.
It added that the following claims have been amended.
• “Try the 3-step programme – an effective long lasting solution to thinning hair.”
• “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.
Furthermore, it was pointed out that the respondent amended the claims prior to receipt of complaint to clearly communicate that Vigro is not effective for hereditary or genetic hair loss. The amended website only talks to non-hereditary hair loss.
The respondent attached evaluation reports from Mr Knowlton of Cosmetic Solutions, Ms Vienings and Dr David Nye.
Ms Vienings submitted that there is no specific and approved regulatory policy or framework for the control of complementary medicines in South Africa save the general provisions of the Medicines Act are applicable to all medicines sold in South Africa. The issues raised by the complainant about the scheduling status of Vigro (because it contains acetylcysteine) are highly speculative and can only be determined by the Medicines Control Council.
Mr Knowlton indicated that the studies relied on support the claims that Vigro assists in hereditary hair loss. He added that the clinical benefits of Follicusan has been proven in the studies at concentrations lower than or equal to the concentration of the ingredient used in the Vigro system.
Dr Nye claims to have critically evaluated the product ingredients, and concluded that the individual ingredients in Follicuson have evidence to show their effect on the growth of hair. He expressly confirmed the contested claims to be fully substantiated by the evidence evaluated.
ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the respective parties.
The respondent argued that despite the fact that the product Vigro has been bought by Nativa (PTY) Ltd the ruling of the ASC (Advertising Standards Committee) should stand. The consequence would be that the respondent would be permitted to continue marketing the product as effective for non-hereditary hair loss.
In the matter Solal Technologies / SASA / 17484 (5 May 2011), the ASA Directorate considered a complaint by the South African Sugar Association against claims made on the website www.solaltech.com. At the time, the Directorate was informed that the respondent (Solal Technologies (Pty) Ltd) had taken over from Solal Technologies Fine Pharmaceuticals (Pty) Ltd. The Directorate ruled that “Given that these are different companies, any substantiation previously accepted in relation to Solal Technologies Fine Pharmaceuticals (Pty) Ltd would not apply to advertising by Solal Technologies (Pty) Ltd.”
A similar aspect can be applied to the matter at hand, meaning that the Directorate is not bound by the decision made by the ASC in a ruling which was made in favour of a different entity. The current matter is a “new” complaint and Nativa as the new owners of the product should substantiate the claims made in their advertising.
The Directorate will consider the remaining issue relating to whether the product assists with hair loss.
Clause 4.1 of Section II requires substantiation from an independent and credible expert for the claims made in advertising. In addition, it is trite that the Directorate requires unequivocal and product-specific substantiation, verifying that the claims are true for the product as a whole when used at the recommended dosage (see ruling under reference Solal Breast Protection Formula / R Jobson / 18707 (15 February 2012) and Kenza Health / HA Steinman / 19189 (18 June 2013) for comprehensive explanations). It should be pointed out that the ASC ruling expressly stated that it did not “decide whether ingredients specific substantiation is sufficient …” which is a key consideration in dealing with the question of substantiation.
Given the ASC’s reluctance to pronounce on the question of whether or not product-specific substantiation is required, the Directorate has no reason to assume that its approach is incorrect.
Clause 4.1.4 of Section II further states that documentary evidence shall emanate from or be evaluated by a person/entity, which is independent, credible, and an expert in the relevant field.
The Directorate is not an expert in this field, and therefore has to rely on independent and credible experts to evaluate the substantiation and unequivocally verify that the claims made for the products as sold in the market are true.
While the respondent submits that the experts diligently evaluated the evidence and substantiate the claims made the Directorate is not convinced that the experts put forth are experts in hair-loss, which is specifically the “field to which the claims relate”. The respondent has certainly not presented any evidence that this is the case.
In previous matters involving Ms Vienings, her expertise was always promoted in the context of weight loss products (see Clicks Apple Cider with Green Tea / HA Steinman / 17985 (27 October 2011) for example), for probiotics (see GastroChoice / ProbiFlora / 13310 (26 August 2009) for example) and varicose veins (see Grace Pharmaceuticals / Ingelheim Pharmaceuticals / 11893 (18 November 2008) for example). There is, however, nothing to suggest that Ms Vienings can objectively be regarded as an expert in the field of hair-loss, whether hereditary or non-hereditary, or the appropriate treatments thereof.
Dr Nye has previously been relied on as a suitable expert in the field of homeopathy and natural products (refer Oscillococcinum / Z Joubert & Another / 18385 (30 July 2012). This does not, however, mean that he is by default an expert in hereditary or non-hereditary hair loss, or the appropriate treatments thereof.
Mr Knowlton has been accepted by the ASA on various occasions for cosmetic products and fabric-care products (refer Ariel Washing Powder / Unilever / 22077 (28 June 20130) and Colgate Sensitive Pro-Relief / GSK / 21798 (30 May 2013) for examples). In addition, in Head and Shoulders / M McKeon / 20554 (30 May 2013), the Directorate accepted Mr Knowlton as an independent and credible expert in the field of hair care and dandruff products. It would therefore appear that he is a suitable expert in the field of hair loss, whether hereditary or non-hereditary.
In the original Vigro ruling, the Directorate took issue with Mr Knowlton’s statement that “… the data submitted to me provides adequate evidence for the scientific substantiation of the claims being made about Vigro, with two caveats: Firstly, that the excipients used in the various studies to determine the efficacy of FollicusanTM would not enhance the effectiveness of the active ingredient, when compared to the excipients design used in the Vigro product range. Secondly, that the level of FollicusanTM used in the Vigro product range was equal to, or greater than the concentration of FollicusanTM used in the studies from which data was provided”. The Directorate ruled that:
“This not only confirms that the product formulation used for testing was different to that available for sale on the market, but also appears to suggest that the excipients (i.e. additional ingredients used to compile the entire product) could impact on efficacy”.
To remedy this, Mr Knowlton now explains that “In these circumstances, where the product containing the active ingredient can directly access its target, the dermal papilla cells, the excipient design is irrelevant, and it has little or no effect on the delivery of the active ingredient itself.”
While this may, or may not be so, the Directorate cannot overlook the fact that the research and testing relied one still appears to relate to active ingredients, rather than the actual product as bought in stores. The Directorate is also mindful of the matter Advanced Lifebuoy / Dettol / 20233 (6 March 2013), where the Final Appeal Committee (the FAC) ruled that “There are several difficulties with this study. The first difficulty is there is no evidence on the record that establishes that the Lifebuoy Total soap which was used in the study is the same as the Lifebuoy Advanced products to which the commercial relates [i.e. nothing to verify that the results relied on are product-specific]. Secondly, this study does not relate to a bathing situation, and there is no evidence as to whether the rate of dilution and the modes of testing is in any way similar to the effect of bathing in a solution of Dettol Antiseptic Liquid [i.e. nothing to show that the application of the product in the studies is exactly the same as the application of the product in real-life].”
Mr Knowlton clarifies that the Vigro product contains higher percentages of Follicusan (the active ingredient), and that this implies equal or probably better benefit and efficacy. This does not, however, change the fact that his comments are based on an assumption that the results obtained in testing on the ingredient can by default be applied to the respondent’s product. This is contrary to the Directorate’s requirement for product-specific substantiation. It is also worth noting that the studies relied on appear to have been relatively small (in one instance 10 people volunteered and in another 29 volunteered). It is unclear why the respondent appears to be unable, or unwilling to conduct similar studies on its product as sold in stores.
In BioBust / Dr HA Steinman / 3247 (13 December 2006), the ASC specifically noted as follows:
“… As was held by the Directorate (which finding we endorse), the verification provided needs to specifically verify the claims used for the product as a whole, when consumed at the recommended dosage …
In response to the submissions by Kenza Health concerning the difficulties inherent in providing objective substantiation for complimentary and / or alternative medicines or remedies, we wish to note that while it might be so that the use of clinical trials in the field of herbal medicine is less established, and that accordingly it may be necessary to take into account other reliable forms of substantiation of the efficacy of such products, what Clause 4.1 of Section II of the Code requires is that all claims that are capable of objective verification must be supported by independent, credible, documentary evidence. The emphasis is on the credibility, independence and veracity of the evidence, as opposed to its form. In the instant case, little to no verified, credible evidence of any sort has been placed before the Tribunal to substantiate the disputed claims. The mere fact that a product is herbal or alternative does not immunise it from the need for any claims made in respect of it to be objectively verified.
While it may not be the practice to do so, it has not been explained why herbal and/ or alternative medications cannot be subjected to formalised clinical testing or research. On the contrary, according to Dr. Nye, who practices in the field, the only way in which Biobust’s claims could be proven to be true, is with a properly conducted, placebo controlled, double blind clinical study. Certainly it appears from many of the website materials attached by Kenza Health, that in certain instances formalised clinical studies have indeed been conducted in order to assess and measure various effects of herbal remedies. Persons who seek to market and advertise products for consumption by the public on the basis that such products have beneficial, medicinal or health related properties have a responsibility to ensure that their products are indeed efficacious as advertised. The fact that the product they are offering may be an alternative or herbal medicine does not excuse them from any such responsibility”.
As explained by the ASC, the Code is not prescriptive in terms of whether or not only clinical trials are acceptable, and the ASA will consider any evidence presented. However, the evidence needs to relate to the “… product as a whole, when consumed at the recommended dosage”. The evidence relied on by Mr Knowlton does not suffice in this regard.
As such the advertising and claims at issue are in contravention of Clause 4.1 of Section II of the Code.
Given the above, the Directorate sees no need to consider the respondent’s proposed amendments to certain claims at this time.
As a result of the above finding:
• The advertising and relevant claims must be withdrawn in its current format;
• The process of withdrawing the advertising and relevant claims must be actioned with immediate effect;
• The process of withdrawing the advertising and relevant claims must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide, and
• The advertising and relevant claims may not be used again in its current format in the future.
The complaint is upheld.
Our arguments/evidence that Vigro does not work
13 June 2012
Advertising Standards Authority of South Africa
Re: VIGRO / HA STEINMAN / 19196 Appeal
Vigro is appealing the Directorate Ruling based on the following central arguments:
1.1. the “product-specific substantiation” requirement is misinterpreted; in the alternative
1.1.1. is unduly onerous;
1.1.2. is out of sync with substantiation requirements world-wide;
1.1.3. creates a barrier to trade;
1.2. the reasoned substantiation evaluation report emanating from Mr John Knowlton (“Knowlton”) constitutes “product-specific substantiation” (if the term “product-specific substantiation” is properly interpreted and applied);
1.3. the reasoned substantiation evaluation report emanating from Knowlton does not suggest that the excipients could impact on efficacy.
I argue that this appeal is unfounded and agree with the ASA’s approach to evaluate the substantiation with care and attention, and to apply the principle of “product-specific substantiation” in the interests of and for the protection of the consumer.
I argue that if the consumer is to be adequately protected from false claims that “product-specific substantiation” is essential and it is therefore not unduly onerous in protecting consumers from misleading claims. Furthermore it does not create a barrier to trade for if the product is adequately substantiated, then there are no barriers to appropriate claims.
I would also argue that it is not within the mandate of the ASA to rule upon the extent to which substantiation is or is not “onerous”.
It would appear that Vigro is basically arguing that they should not have to prove that their product works, and by asking them to do so is a barrier to trade! An analogy: I have developed a pink soap that I claim that if an individual washes with it, will prevent AIDS/HIV. I have added to the soap an ingredient that in the laboratory in a cell culture dish kills the AIDS/HIV virus when the solution is poured onto the virus, e.g., a Dettol-like fluid. Should I be allowed to claim that washing with my pink soap will protect humans or cure them of AIDS/HIV or should I have to prove that my pink soap does have “product-specific substantiation” in humans?
A second and real example: One of the “credible-experts” in this matter, Ms Alison Vienings has previously substantiated Glomail’s Bioslim based on ingredient-specific substantiation, a principle she and Vigro argue for. Recently a post-graduate student at Stellenbosch University evaluated the claims for Bioslim for her Masters’ degree.[i] A total of 5 credible experts evaluated her study. Her findings were damning: Bioslim had zero effect on weight-loss. Therefore one can conclude that because of Ms Vienings “ingredient-specific” substantiation, millions of consumers were duped into believing the claims for this product.
I also argue that the notion of “credible expert” does NOT require the ASA to automatically accept, nor assume, that the evidence emanating from said expert is therefore correct, acceptable or accepted. It is clear from a number of recent ASA rulings, that Ms Vienings, one of the “credible experts” in the Vigro matter, has taken data out or context, has cherry-picked evidence, and has tried to convince the ASA to accept substantiation which indeed was contradicted by every scientific principle applicable to products involving consumers health, and I argue this was done for commercial gain of the advertisers, manufacturers and sellers of such products. Of course, it would also not hurt Ms Vienings’ “business” if she were to be able to adequately substantiate products on an ingredients basis only. I would respectfully submit that it would be to her commercial benefit to have non-product-specific substantiation accepted and that in this regard she could be considered non-independent (or even a potential competitor).
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!
Vigro’s appeal tries to argue 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. It is my contention that the “credible experts” have become the equivalent of “guns-for-hire” in substantiating almost any product for commercial gain. In support for this argument, I request that the ASA supply the appeal committee with the raft of rulings that were contrary to Ms Vienings substantiation showing very clearly that the ASA were easily able to dissect and demonstrate that Ms Vienings had cherry-picked data to support her arguments, or had excluded more solid evidence, and had by her own admission in one instance, not evaluated all the data.
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 will bring the following facts to the committee which will indicate the paucity and illogical arguments brought in support of the appeal.
I evaluate three critical questions:
- What is the evidence for Vigro that it will have any effect on hair loss?
- What is the evidence for Follicusan™, the major “ingredient” in Vigro, that it will have any effect on hair loss?
- 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:
- 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
- Natural Medicines Comprehensive Database (NMCD) (“Unbiased, Scientific Clinical Information on Complementary, Alternative, and Integrative Therapies”) http://naturaldatabase.therapeuticresearch.com/
- 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.
- Studies for the efficacy of Follicusan®, the prime ingredient in Vigro bio-tonic for which the said claims are being made.
- There is not a single study published in the peer-reviewed literature demonstrating the efficacy for Follicusan® (Follicusan® is actually a mix of ingredients).
- Searching both Pubmed and NMCD for any evidence for research on Follicusan™ finds not a single document.
- 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.
- 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!
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 . . .”
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.
- 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:
biologically active signaling proteins,
ethylpanthenol (provitamin B5),
acetyl methionine, in a water-alcohol medium.
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.
- Alcohol Denat.
- Panthenyl Ethyl Ether*
- Milk Protein
- Acetyl Cysteine
- Acetyl Methionine**
- Sodium Citrate
- Citric Acid
*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)
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:
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.
Water (Aqua), Alcohol Denat. Panthenyl Ethyl Ether, Inositol, Milk Protein, Lactose, Acetyl Cysteine, Acetyl Methionine, Sodium Citrate, Citric Acid. (emphasis added)
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.
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.
Br J Dermatol. 2011 Dec;165Suppl 3:24-30. doi: 10.1111/j.1365-2133.2011.10633.x.
A novel cosmetic approach to treat thinning hair.
Davis MG, Thomas JH, van de Velde S, Boissy Y, Dawson TL Jr, Iveson R, Sutton K.
P&G Beauty & Grooming Research and Development, Sharon Woods Innovation Center, 11511 Reed Hartman Highway, Cincinnati, OH 45241, USA.
Many of today’s treatments associated with ‘thinning hair’, such as female pattern hair loss and telogen effluvium, are focused on two of the key aspects of the condition. Over-the-counter or prescription medications are often focused on improving scalp hair density while high-quality cosmetic products work to prevent further hair damage and minimize mid-fibre breakage. Fibre diameter is another key contributor to thinning hair, but it is less often the focus of medical or cosmetic treatments.
To examine the ability of a novel leave-on technology combination [caffeine, niacinamide, panthenol, dimethicone and an acrylate polymer (CNPDA)] to affect the diameter and behaviour of individual terminal scalp hair fibres as a new approach to counteract decreasing fibre diameters.
Testing methodology included fibre diameter measures via laser scan micrometer, assessment of fibre mechanical and behavioural properties via tensile break stress and torsion pendulum testing, and mechanistic studies including cryoscanning electron microscopy and autoradiographic analysis.
CNPDA significantly increased the diameter of individual, existing terminal scalp hair fibres by 2-5 μm, which yields an increase in the cross-sectional area of approximately 10%. Beyond the diameter increase, the CNPDA-thickened fibres demonstrated the altered mechanical properties characteristic of thicker fibres: increased suppleness/pliability (decreased shear modulus) and better ability to withstand force without breaking (increased break stress).
Although cosmetic treatments will not reverse the condition, this new approach may help to mitigate the effects of thinning hair.
© 2011 Procter & Gamble.BJD © 2011 British Association of Dermatologists.
“G. Lutz (1), R.D. Petersen (1)
(1) CLR GmbH, Berlin, Germany.
In the past new substances for treatment of hair loss have been developed. Beside these medicaments also cosmetic preparations could show a certain hair growth stimulating potency.
In a pilot study, a new cosmetic preparation called Follicusan® was tested in vitro by cell cultures and in vivo by conventional trichograms. Follicusan® contains a fraction derived from milk, DL-ethylpanthenol, inositol, N-acetyl-cysteine and N-acetyl-methionine. In fibroblast cell cultures, a 3.2% solution of Follicusan® was found to increase mitochondric activity by nearly 100% and protein synthesis of fibroblasts by almost 50%, compared to 5% of FCS.
In vitro experiments with human dermal papilla cells have shown strong stimulatory influences by Follicusan® in a 3.2% concentration. Cell proliferation was increased up to 72%, assessed by measuring the content of bromodeoxyuridine. Synthesis of compounds of the specific dermal papilla ECM was stimulated: type IV collagen up to 17%; heparansulfate proteoglycan up to 21%.
In ten female and male volunteers suffering from androgenetic and diffuse alopecia, a 5% Follicusan® gel preparation was applied once a day on the scalp for a period of 3 to 4 months.
In female volunteers with a diffuse hairloss, a significant decrease of telogen hairs were observed, accompinied 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.”
[i] Ting Lee. Department of Nutrition, Stellenbosch University. The effectiveness of Bioslim as a weight loss supplement and if the marketing of the Bioslim brand has an influence on the placebo response. 2012 http://scholar.sun.ac.za/bitstream/handle/10019.1/20329/lee_double_2012.pdf?sequence=1
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