FDA has adequate enforcement authority, sources say in reaction to Driven Sports exposé

By Hank Schultz

- Last updated on GMT

Related tags American herbal products Dietary supplement Law Marketing

FDA has adequate enforcement authority, sources say in reaction to Driven Sports exposé
The Food and Drug Administration has enough tools to police the dietary supplement sector.  That was the reaction from industry in the wake of yet another negative story about the product category in a high profile publication, in this case, USA Today.

In an article published on Thursday, USA Today​ delved into sports nutrition product marketer Driven Sports and its founder Matt Cahill. The articled laid out Cahill’s checkered history in the business, which includes personal and class action lawsuits, a jail sentence and the marketing of steroid containing products.

Adequate oversight

Judy Blatman, senior vice president of communications for the Council for Responsible Nutrition said she couldn’t comment on Driven Sports directly.  But she had this to say about the state of regulatory oversight over the whole industry:

“We do think that are always going to be companies that are looking for loopholes in the law. If companies find them, it is not issue with the law itself.

“It is the job of FDA to enforce the law. The dietary supplement industry is appropriately regulated.  There is ample authority for the agency to enforce those laws and to make sure consumers are protected,”​ she said.

“It is concerning any time you see this kind of a story. These kinds of examples are not representative of mainstream companies that are looking to have a long term relationship with consumers,”​ Blatman said.

Loren Israelsen, president of the United Natural Products Alliance, had this to say:

"We were troubled to read the report in USA Today regarding a specific company and products, which if true, suggests a need for further regulatory oversight and investigation. With the authority at FDA's disposal, we would hope for a prompt review, and should there be irregularities or violations of law, that appropriate government action be taken."

Questions about dendrobium

Even before the USA Today​ story, Cahill came to renewed attention because his latest product, Craze, a preworkout formula, has been a big seller, earning recognition from Bodybuilding.com. The product contains an ingredient listed on the label as an extract of dendrobium, an orchid species.  Among the chemicals listed under dendrobium extract is phenethylamine, a member of the stimulant family.

The question many raised about this ingredient is similar to the one raised about DMAA.  USP Labs, which manufactured several DMAA-containing pre workout and weight management products, has always maintained that DMAA can be found in geraniums.  A number of scientific papers have disputed that notion.  In any case, FDA mandated that DMAA be removed from the market and recently seized some USP products that contained DMAA from a GNC warehouse.  USP Labs, the last DMAA holdout, had already ceased production of DMAA products and recently agreed to destroy its remaining inventory of products that contained the ingredient.

Whether the phenethylamine in Craze can be found in dendrobium is a similar question. Even if that were true, the question remains whether there are commercially viable quantities of the chemical in nature, or whether it was synthesized in a laboratory. And if it never existed in nature, it at least fails to qualify as a lawful dietary ingredient or could even be considered an unapproved new drug.

Tests in Sweden

Earlier in 2013, the National Laboratory of Forensic Science (SKL) in Sweden tested what it considered to be Craze and said it found traces of amphetamine-like compounds including n-etyl-1-fenyl-butan-2-amin and phenethylamine.

Cahill said the Swedish results came from testing a counterfeit product.

“We refute this finding as erroneous,”​ he said. “Authentic Craze does not contain (n-etyl-1-fenyl-butan-2-amin).”

Cahill said the other compound mentioned by SKL was legal and legally labelled on its product.

“The report states that ‘fenetylamin” (phenethylamine in English) was identified, which is solely related to amphetamine. This does not mean that it has the same effects as amphetamine. Phenethylamine is correctly labeled as an ingredient on our product and is found in chocolate as well as dozens of plants and food products,” ​he said.

Checkered background

The USA Today story detailed Cahill’s checkered background. Cahill spent time in prison for marketing a product ostensibly for weight management that consisted of a chemical sometimes used as a pesticide mixed with baking soda.  A young woman died of organ failure after ingesting a number of the pills at once. 

While in prison, Cahill marketed a sports product that contained an illegal steroid.  In a 2008 deposition connected to a lawsuit filed by a former college baseball player who said he suffered liver problems and lost his scholarship after using that product, Cahill said he chose the steroid after finding it referenced in a book without, apparently, further investigation of its safety data. Cahill is currently under a federal indictment for marketing another steroid product.

Trade association member

Driven Sports, like USP Labs and Bodybuilding.com, is a member of the American Herbal Products Association.  AHPA president Michael McGuffin had this reaction to the USA Today​ story:

“Driven Sports is a member of the American Herbal Products Association (AHPA), having joined in June 2012. AHPA is committed to its mission of promoting the responsible commerce of herbal and botanical supplements. All members agree to abide by the AHPA Code of Ethics and Business Conduct, which includes a requirement to conform to all federal, state and local regulations.

“The above cited article reports on unproven allegations about one product against the background of an industry that has a history of providing safe and lawful supplements,”​ McGuffin said.

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