Biogen ZMA Testo – ASA ruling

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Posted 28 January 2015

Dis-Chem were selling a product called Biogen ZMA Testo with the claim that it has an effect on ‘muscle protein synthesis”. At the Biogen website, the following claims are being made (now discontinued):

ZMA Testo has been formulated using a precise combination of several key ingredients that are aimed at significantly enhancing your testosterone levels. These include Tribulus Terrestris and ZMA, key factors in maximizing free testosterone potential. Tribulus has been indicated to promote healthy hormone function, enhance muscle tone and support athletic training whilst ZMA has been proven to significantly increase anabolic hormone levels and muscle strength in trained athletes”.  It also claimed on the website that this product is effective as a “Natural Testosterone booster” “Increase strength and lean muscle” and “Aromatization Blocker

A complaint was laid with the ASA, pointing out that the claims for the product are not true, and worse, that not a single study confirms the claim “ZMA has been proven to significantly increase anabolic hormone levels and muscle strength in trained athletes” but in fact, that two studies reported it not to:

The first study concludes: “Results indicate that ZMA supplementation during training does not appear to enhance training adaptations in resistance trained populations.”

The second study concludes: “CONCLUSIONS: The present data suggest that the use of ZMA has no significant effects regarding serum testosterone levels and the metabolism of testosterone in subjects who consume a zinc-sufficient diet.”

Dis-Chem response was that the product had been discontinued. So Dis-Chem (Biogen), were prepared to sell a product using false claims?

The ASA ruling follows, then the ASA complaint.

ASA Ruling

In the matter between

DR HARRIS STEINMAN

and

ULTIMATE SPORTS NUTRITION (PTY) LTD t/a BIOGEN

8 December 2014

BIOGEN – ZMA TESTO / H STEINMAN 2014 -1563 F

Dr Steinman lodged a consumer complaint against Biogen website advertising promoting their ZMA Testo product. His complaint mentions that the product is sold at Dis-Chem stores with a claim that it has an effect on “muscle protein synthesis”.

The website www.biogen.co.za/products/zma-testo features an image of the packaging bearing the words “ZMA TESTO MUSCLE PROTEIN SYNTHESIS” and states, inter alia, as follows:

“ZMA Testo has been formulated using a precise combination of several key ingredients that are aimed at significantly enhancing your testosterone levels. These include Tribulus Terrestris and ZMA, key factors in maximising free testosterone potential. Tribulus has been indicated to promote healthy hormone function, enhance muscle tone and support athletic training whilst ZMA has been proven to significantly increase anabolic hormone levels in trained athletes.

A very important aspect of ZMA Testo’s unique formula is the inclusion of Chrysin. Chrysin is a naturally occurring flavone that helps maximise the benefits of the aforementioned testosterone boosting ingredients. Chrysin inhibits aromatase activity to prevent the conversion of testosterone to unwanted hormones such as estrogen [sic] thereby increasing the body’s natural testosterone levels.

ZMA-Testo is ‘one of a kind’ due to the way that the mechanisms of its ingredients combine for maximum elevation and support of natural testosterone. This leads to increased gains in strength, lean muscle, energy and libido whilst preventing any excess estrogen [sic] production”.

COMPLAINT

The complainant submitted that the advertising made various unsubstantiated claims relating to the efficacy of the product. He explained that there is not a single study that has evaluated the efficacy of this combination of ingredients in humans. In evaluating the research he could find, he predominantly pointed out that such research almost exclusively finds that the relevant ingredients were “possibly ineffective”. One study evaluated the efficacy of a “water based extract of Eurycoma longifolia” in men with low testosterone levels, and at a dose higher than indicated by the respondent.

However, this product is aimed at normal individuals or sportsmen who do not likely have low testosterone levels. Other studies on some of the ingredients specifically point out that there was no, or at best, no significant improvement on sports performance. As a result, the claims are untrue.

The complainant added that the respondent has a history of making unsubstantiated claims, and that sanctions would be in order.

RELEVANT CLAUSE OF THE CODE OF ADVERTISING PRACTICE

In light of the complaint Clause 4.1 of Section II (Substantiation) was taken into consideration.

RESPONSE

The respondent submitted that the product had been discontinued and ran out of stock. The advertising has been removed from the website and there will be no need to make any further claims or advertisements for the product.

ASA DIRECTORATE RULING

The ASA Directorate considered all the relevant documentation submitted by the respective parties.

The ASA has a long standing principle which holds that where an advertiser provides an unequivocal undertaking to withdraw or amend its advertising in a manner that addresses the concerns raised, the undertaking may, at the discretion of the ASA, be accepted without considering the merits of the matter

The respondent submitted that the product is discontinued, and that no claims or advertising for the product would be published. It added that its category managers had confirmed that stock has been depleted at stores as well.

As the respondent’s undertaking to no longer use the claims and the advertising addresses the complainant’s concerns, there is no need for the Directorate to consider the merits of the matter.

The undertaking is therefore accepted on condition that the advertising is withdrawn in its current format within the deadlines stipulated in Clause 15.3 of the Procedural Guide, and is not used again in future.

While the complainant made reference to a pattern of infringements, the Directorate notes that the last adverse ruling (and sanction) against the respondent was issued on 31 January 2014. While it can be accepted that the product in that matter (Biogen Tribulus / H A Steinman / 20408 (31 January 2014)) also claimed to have some impact on testosterone, the Directorate is not convinced at this time that this warrants additional sanctions beyond the removal of the advertising from any and all media.

A preliminary search on the respondent’s website revealed that the page at issue no longer appeared. As such, the Directorate sees no need to impose additional sanctions at this time.

ASA Complaint

15 October 2014

Advertising Standards Authority of South Africa
Box 41555
Craighall 2024

Dear Sir/Madam,

Re: Biogen ZMA Testo

Dis-Chem is selling a product on their shelves called Biogen ZMA Testo with the claim that it has an effect on ‘muscle protein synthesis”.

At the Biogen website (http://www.biogen.co.za/products/zma-testo), the following claims are being made:

“ZMA Testo has been formulated using a precise combination of several key ingredients that are aimed at significantly enhancing your testosterone levels. These include Tribulus Terrestris and ZMA, key factors in maximizing free testosterone potential. Tribulus has been indicated to promote healthy hormone function, enhance muscle tone and support athletic training whilst ZMA has been proven to significantly increase anabolic hormone levels and muscle strength in trained athletes. –

 

It also claims on the website that this product is effective as a “Natural Testosterone booster” “Increase strength and lean muscle” and “Aromatization Blocker”

The product contains the following ingredients:

Chrysin, Tribulus Terrestris, Chrysin, ZMA, Eurycoma longifolia Jack 20:1, Vitamin E, Vitex Agnus Castus Extract, Naringinin

Clause 4.1 of Section II of the ASA’s Code states “Before advertising is published, advertisers shall hold in their possession documentary evidence as set out in Clause 4.1, to support all claims, whether direct or implied, that are capable of objective substantiation.”

and

“Documentary evidence, other than survey data, shall emanate from or be evaluated by a person/entity, which is independent, credible, and an expert in the particular field to which the claims relate and be acceptable to the ASA”.

I argue that there is no evidence to support the claim that this product, this combination of ingredients, or the ingredients per se can support the claims being made for the product, inter alia, “muscle protein synthesis”, “significantly enhancing your testosterone levels”, or “maximizing free testosterone potential”. I also argue that there is no evidence to support the claims “to promote healthy hormone function, enhance muscle tone and support athletic training” and “ZMA has been proven to significantly increase anabolic hormone levels and muscle strength in trained athletes.”

Firstly, there is not a single study that has evaluated this combination of ingredients in man.

Secondly, I have evaluated the evidence from Natural Medicines Comprehensive Database (NMCD), previously regarded as a reputable source of information on these ingredients, and where insufficient evidence was found, included PubMed, also an acknowledged source of credible information, and found no support for the claim of the product in toto, and no robust support for the claims with regard to the individual ingredients.

Chrysin 800mg

NMCD states:

“Effectiveness:

POSSIBLY INEFFECTIVE

Athletic performance. Taking chrysin orally, in combination with androgen precursors, doesn’t seem to be effective for enhancing resistance training in athletes. The combination of chrysin 300 mg with androstenedione, dehydroepiandrosterone (DHEA), puncture vine, indole-3-carbinole, and saw palmetto taken daily for eight weeks does not appear to increase testosterone concentrations, reduce the estrogenic effects of androstenedione, change body composition, or increase strength in response to resistance training (7514).

There is insufficient reliable information available about the effectiveness of chrysin for its other uses.”

Tribulus Terrestris 1400mg

NMCD states:

“Effectiveness:        

POSSIBLY INEFFECTIVE

Athletic performance. Taking tribulus orally, alone or in combination with other herbs and supplements such as androstenedione, doesn’t seem to enhance body composition or exercise performance in athletes (7514,13255).

ZMA 1224mg

There is no information in NMCD except to point out the ingredients contained in ZMA: Magnesium 150 mg • Vitamin B6 3.5 mg • Zinc 10 mg.

However, PubMed lists two studies that evaluated the effects of ZMA.

The first study concludes: “Results indicate that ZMA supplementation during training does not appear to enhance training adaptations in resistance trained populations.”

Wilborn CD1, Kerksick CM, Campbell BI, Taylor LW, Marcello BM, Rasmussen CJ, Greenwood MC, Almada A, Kreider RB. Effects of Zinc Magnesium Aspartate (ZMA) Supplementation on Training Adaptations and Markers of Anabolism and Catabolism. J Int Soc Sports Nutr. 2004 Dec 31;1(2):12-20. doi: 10.1186/1550-2783-1-2-12.

http://www.ncbi.nlm.nih.gov/pubmed/18500945

The second study concludes: “CONCLUSIONS: The present data suggest that the use of ZMA has no significant effects regarding serum testosterone levels and the metabolism of testosterone in subjects who consume a zinc-sufficient diet.”

Koehler K1, Parr MK, Geyer H, Mester J, Schänzer W. Serum testosterone and urinary excretion of steroid hormone metabolites after administration of a high-dose zinc supplement. Eur J Clin Nutr. 2009 Jan;63(1):65-70. Epub 2007 Sep 19.

http://www.ncbi.nlm.nih.gov/pubmed/17882141

Eurycoma longifolia Jack 150mg

NMCD states:

“INSUFFICIENT RELIABLE EVIDENCE to RATE

“Preliminary clinical research shows that taking a water-based extract of Eurycoma longifolia 200 mg daily for a month might significantly increase testosterone levels in men with low testosterone levels.”

In other words, this study evaluated not the effect of testosterone boosting in normal individuals or sportsmen (the actual targeted consumer group), but men with low testosterone levels, and, the dose was significantly higher (400 mg/day) compared to the 150 mg in this product. The study that NMCD refers to is at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4085925/

A second study on PubMed states in the introduction to the research project that “Eurycoma longifolia Jack (ElJ) has been shown to elevate serum testosterone and increased muscle strength in humans” but has no references to support this claim, and further into the article, states explicitly “With all these documented properties of ElJ, particularly its antioxidative and testosterone enhancing properties, it is surprising to note that studies on the effects of ElJ on sports performance are scarce. However, several studies have demonstrated that ElJ supplementation did not seem to improve sports performance.[26,27,28]”[my emphasis]

Chen CK1, Mohamad WM2, Ooi FK1, Ismail SB3, Abdullah MR2, George A. Supplementation of Eurycoma longifolia Jack Extract for 6 Weeks Does Not Affect Urinary Testosterone: Epitestosterone Ratio, Liver and Renal Functions in Male Recreational Athletes. Int J Prev Med. 2014 Jun;5(6):728-33.

http://www.ncbi.nlm.nih.gov/pubmed/25013692

Vitex Agnus Castus Extract

“NMCD states:

POSSIBLY EFFECTIVE: Premenstrual dysphoric disorder and PMS.”

Nothing on the claims being made for this product

Naringinin (“Naringenin”)

Not to be confused with naringin.

There is no evidence for this ingredient to support the major claims being made for this product. Naringenin is also found in grapefruit, therefore drug interactions, i.e., with the other ingredients, is possible.

I therefore argue that the claims for this product are unsubstantiated and misleading to the consumer, and brings advertising into disrepute.

I also argue that in a previous ASA ruling against Biogen Tribulus, a product containing Tribulus Terrestris, that similar claims were made for that product (“testosterone Booster”), claims that the ASA ruled against. (Biogen Tribulus / HA Steinman / 20408). Yet this appears to have had no influence on Biogen’s attitude to the consumer and advertising, making a substantially similar claim for the use of this ingredient in this product: “ . . . significantly enhancing your testosterone levels. These include Tribulus Terrestris . . .” I therefore argue that sanctions are warranted.

Sincerely,

,

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