Androfen Calculations Off Target For Reasonable Interpretations Of Claim – ERSP

Androfen should discontinue claims its testosterone-boosting supplement can “reduce body fat by over 200%” because consumers can interpret it in a way that is not supported, ERSP says. The firm can continue to claim the fenugreek product enhances libido and promotes body fat loss.

Androfen LLC cites differences in test groups’ results to claim its testosterone-boosting supplement could “reduce body fat by over 200%,” but the Electronic Retailing Self-Regulation Program says the firm’s calculations likely will not add up for consumers.

Androfen should discontinue the claim for its eponymous-branded product because consumers can interpret it in a way not supported by evidence from a clinical study the firm submitted for ERSP’s review, the Council of Better Business Bureaus industry self-regulation arm determined in a report released Sept. 25.

“A marketer has the burden of supporting any reasonable interpretation of the claims that are disseminated in its advertising,” ERSP attorneys said.

ERSP explained consumers reasonably could interpret the unqualified claim as losing more than 200% of body fat from baseline measurements, but the clinical study the firm provided supports only the interpretation that the treatment group’s percentage of fat loss was more than 200% greater than the placebo group.

Specifically, the randomized, controlled trial found the percentage of body fat in men who participated in an eight-week resistance-training program and took the fenugreek-based supplement fell 1.78% compared to a 0.55% drop in body fat percentage in the men who participated but took a placebo.

The difference between those percentages, 224%, is the basis for the 200% reduction claim, according to the report.

ERSP also notes the study reports “no significant difference between the groups for total body weight loss over the 8 week period,” which is “inconsistent” with the 200% fat reduction claim and imagery of an obese man transformed to a toned man.

Additionally, ERSP questioned the value of the claim given that the 200% difference in body fat reduction between the control and placebo group is not corroborated in any other testing firm provided.

While Androfen will consider the recommendations, it disagrees with ERSP’s conclusion that consumers would assume the fat loss in the online claim was from baseline.

The Los Angeles firm argues in a statement included with ERSP’s report that consumers most likely would see the claim first on a television commercial that included a “clear and conspicuous disclosure of the ‘versus placebo’” that characterized the quantified fat loss claim before they purchase the product.

Androfen also takes issue with ERSP’s claim that the reliability of the 200% claim was questionable.

“The study that supports the claim was conducted by researchers from Baylor University, a well-respected clinical research center in the nutritional supplement field, and there is nothing in the factual record before ERSP to suggest that the protocol, execution or data analysis of the study was in any way flawed,” the firm said.

The advertising watchdog also questioned the context of the 200% fat reduction statement in the second claim: “In a university clinical study, men taking the active ingredient in Androfen significantly increased their testosterone in only 12 hours and reduced their body fat by over 200% versus a placebo.”

Although this version of the claim referenced the comparison to the placebo, ERSP said it would be reasonable for consumers to think both results were supported by the same study. But the results were from different studies and the claim should be discontinued, ERSP said.

Androfen “respectfully questions the materiality of the fact” the two claims come from two studies but are placed in one claim.

“While the reference to a single study is technically incorrect and inadvertent, the material fact is that each statement is backed by a controlled human clinical study and thus is properly substantiated,” Androfen said.

No On Muscle Mass, Yes On Libido

The firm also should discontinue claims that the fenugreek product can “increase muscle” and “maximize muscle mass,” ERSP said.

The industry watchdog group has told several other fenugreek marketers to discontinue similar claims because the scientific evidence did not support them ( (Also see "In Brief: warning letters, Emergen-C settlement, RapidMed expansion, CRN promotes MacKay" - Pink Sheet, 10 Feb, 2014.) and (Also see "In Brief: Nutrition Facts Update, Valeant Sales" - Pink Sheet, 3 Mar, 2014.)).

Unlike previous firms that relied on the same studies, Androfen submitted two additional studies to support the muscle claims, but ERSP said these also fell short.

It explained the Baylor study did not conclude that treatment increased muscle mass, but rather that it was “an effective stimulus for decreasing fat mass.”

The second study Androfen submitted as support was a five-point self-satisfaction scale rating on how participants felt about their muscle and strength.

While this type of study may sufficiently measure libido and sex stamina, it is a less reliable indicator than a more traditional strength measurement, such as increased muscle growth, ERSP said.

Androfen did not object to these assessments.

Finally, ERSP said the firm supported core claims that its product is clinically proven to boost testosterone, enhance sexual drive and libido and the general claim it promotes body fat loss.

Androfen said it appreciates ERSP’s acceptance of these claims and even though it disagrees with the other claim assessments, it will “give serious consideration to the recommendations” from ERSP.

An Advertising Self-Regulatory Council spokeswoman said is not necessary for firms to say they will change their claims to comply with ERSP’s recommendations, but that they should understand that if they fail to comply, the group can refer its review to the Federal Trade Commission.