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Microsoft word - herbal-h decision

DECISION
FIRST INSTANCE JURY
Advertising Standards Authority, A13-224117 Decision issued
Wednesday 10 April 2013
Orestis Iosif / Cyprus Advertising & Communications Agencies’ Association, Chairman Olga Papastavrou / Cyprus Advertising & Communications Agencies’ Association Georgia Anastassiou / Cyprus Advertisers’ Association The complainant challenges whether the efficacy claims for the Herbal-H formula/product can be substantiated. They specifically challenge the following claims: o ‘not only prevents hair loss, but promotes re-growth’ o ‘is scientifically formulated to activate the hair from the mother cell and is highly effective in treating male- o ‘It works by increasing the blood circulation, replenishing GI, providing nutrition to the skin and the scalp and activating meridian, allowing hair follicles to regain function and effectively grow new hair’ and o ‘to prevent damage to the liver and stomach’
Advertiser’s Response:

The advertiser claimed that the product Herbal-H contains several hair growing and anti-hair loss ingredients. One
specifically is called minoxidil which for many years has been known to treat alopecia hair loss and effectively regrow
thicker hair. The advertiser claimed that, as proven in numerous scientific studies worldwide, minoxidil has become
one of the most popular ways for treating hair loss. Five documents of scientific studies performed on some of the
product's ingredients were forwarded to the jury. Three of those referred to Minoxidil (Mechanism-of-minoxidil.pdf,
Minoxidil-dermal-papilla-cells.pdf and Topical-minoxidil-30month-study.pdf). The other two referred to two other
ingredients of the product, Saw Palmetto (Saw-palmetto-study.pdf) and Polygonum Multiflorum (Topical-
application-of-Polygonum-multiflorum.pdf’).
www.fed.org.cy
In terms of the specific claims challenged: i. Not only prevents hair loss, but promotes re-growth – according to the advertiser, the document ‘saw-
palmetto-study.pdf’ explains how the ingredient Saw Palmetto found in Herbal-H could prevent hair loss.
Also the document ‘topical-minoxidil-30month-study.pdf’ explains how Minoxidil stimulated some hair
regrowth in all patients with andro-genetic alopecia (the main cause of hair loss). Finally, the ‘Topical-
application-of-Polygonum-multiflorum.pdf’ further explains how another ingredient found in the Herbal-H
formula, called Polygonum Multiflorum, can promote more hair re-growth.
ii. Is scientifically formulated to activate the hair from the mother cell and is highly effective in treating
male-pattern baldness – the document 'Minoxidil-dermal-papilla-cells.pdf’ explains how minoxidil’s main
target site for action is the dermal papilla cell which is the main (in other words, mother cell) of the hair
follicle.
iii. It works by increasing the blood circulation, replenishing GI, providing nutrition to the skin and the scalp
and activating meridian, allowing hair follicles to regain function and effectively grow new – the
document ‘mechanism-of-minoxidil.pdf’ explains how 3% minoxidil topical solution is clinically effective to
increase blood flow.
iv. To prevent damage to the liver and stomach – Because the product is not induced orally and is only applied
externally using a spray there is no potential damage to the liver and stomach.
Jury Assessment:

1. The jury noted the documentation forwarded by the advertiser, which pertains to some of the product’s
ingredients, namely Minoxidil, Saw Palmetto and Polygonum Multiflorum. However, it also noted that none of the documents refers to tests and results regarding the product itself, in its finalized form as available for sale. 2. The jury is of the opinion that an average consumer reviewing the Herbal-H website would get the impression
that the specific product is unique, it has been tested and its results have been documented. Many references
throughout the website1 help create this perception. However, the jury again notes that no such evidence was
received. Moreover, in terms of the studies forwarded by the advertiser, it is the jury’s opinion that none of
them conclusively and unequivocally supports the claims of the advertiser for the specific product on sale
.
3. In addition to the above, the jury is of the opinion that the references and/or conclusions in the documents
forwarded by the advertiser, cannot be generalized to support the claims i, ii and iii on the effectiveness of the Herbal-H product. More specifically: o As far as Claim (i) is concerned, the jury notes that the article on Saw Palmetto refers to 4 studies giving
very little detail; however, it is clear that 3 of those studies include oral dosing of the ingredient. The study on Polygonum multiflorum is a first time study report on mice, the results of which merely 1 E.g. In http://www.herbal-h.com/about-us.php “Herbal-H is the first herbal product medically proven to treat
hair loss
and effectively regrow hair”, “Clinically tested and doctor recommended, the Herbal-H Advanced Hair
Growth Treatment.”. In http://www.herbal-h.com/penetrating-peel-technology.php, “ Herbal-H is a unique hair
growth solution
using a technology and formula that really works”.
www.fed.org.cy
suggest that Polygonum multiflorum extract promotes hair growth by inducing anagen phase in resting
hair follicles
”. The only study that adds support to the claim of hair regrowth is the 30-month study
application of topical minoxidil. However the effectiveness results of this study refer to a much longer
time frame than the one specified on the herbal-h website for the use of the Herbal-H formula.
o The document 'Minoxidil-dermal-papilla-cells.pdf’ does not lend support to the advertiser’s Claim (ii)
above. The results refer to a study on cultured dermal papilla cells. The authors expressly note that
“More importantly, this growth stimulating effect upon DPCs through molecular pathways of ERK, Akt,
Bcl-2, and Bax by minoxidil observed in this study is not necessarily a direct indication that minoxidil
stimulates hair growth in vivo by same mechanism
. These need to be investigated further in the
future
”.

o The document “Mechanism of Minoxidil” does not lend support to the advertiser’s Claim (iii) above. In
fact, it contradicts it by stating that –inter alia- “The idea that minoxidil stimulates hair growth by
increasing cutaneous blood flow has been the subject of two studies giving contradictory results. Wester
et al. [59] studied the effect of topical minoxidil (1%, 3%, 5%) on blood flow in balding scalp using laser
Doppler velocimetry (LDV) and photopulse plethymography. Both methods showed an increase in skin
blood flow following application of minoxidil that was statistically significant with the 5% solution. On the
other hand, Bunker and Dowd,[60] also using LDV, failed to find any change in skin blood flow following
application of 3% minoxidil topical solution to the scalp in 10 balding men
, whereas all but one showed
an increase in blood flow after applying the vasodilator 0.1% hexyl nicotinate. The difference in results
may have been due to the higher concentration of minoxidil used in the first study although, as Bunker
and Dowd point out, 3% minoxidil topical solution is clinically effective”.

o As far as claim iv is concerned, since no evidence was submitted, the jury did not examine the claim.
Moreover, the jury notes that –despite an ASA adjudication in 2010- which found that the claim that the Herbal-h treatment worked for 95% of men could not be substantiated, the home page in at least two places (see screenshots) continues to promote that claim. Given the above, the Jury is of the opinion that the claims i, ii and iii breach articles 5 (Truthfulness), 6 (Use of technical/scientific data and terminology) and 8 (Substantiation) of the Code of the Cyprus Advertising Regulation Organization. Claim iv breaches article 8 (Substantiation).
Action:

None of the claims should appear again in their current form.
www.fed.org.cy

Source: http://www.fed.org.cy/fed/userfiles/Herbal-H_Decision.pdf

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