Sports nutrition has a history of pushing the envelope of innovation into questionable terrain. Prohormones, 1,3-dimethyamylamine (DMAA) and selective androgen receptor modulators (SARMs) are infamous examples of ingredients that played with the fringes of regulations drawing the ire of FDA and plunging brands and formulators into legal jeopardy.
Ingredient trends often follow prohibited lists in sport, exploiting gaps in the language and making prohibited claims on unlisted substances in a game of cat and mouse. Essentially it involves looking at ingredients from the past and breaking out a crystal ball to see what might be in store for the future as ingredients continue to push the envelope of sports nutrition.
With today’s sports nutrition consumer market dominated by soccer moms, weekend warriors and active lifestylers, sports nutrition has evolved from a primary focus on muscle gains and explosive energy to include overall health and wellness, anti-aging, hormone support and more. Determining whether sports nutrition ingredients meet compliance requirements of the Dietary Supplement Health and Education Act of 1994 (DSHEA)(Pub. L. 103-417) is vital but challenging. Interpreting where an ingredient fits in the scope of banned substances in sport is even more of a quandary. Many grey areas are subject to interpretation, especially as the category expands.
Vinpocetine has gained favor as a cognitive performance ingredient. The compound is a synthetic derivative of the naturally present indole alkaloid vincamine, present in Vinca minor (lesser periwinkle). Several NDIs were filed and approved for vinpocetine apparently making it legal. On Sept. 6, 2016, however, FDA announced its tentative conclusion that “vinpocetine does not meet the definition of a dietary ingredient,” opening up a comment period. A final decision is still pending. Vinpocetine was developed in Hungary and marketed as the drug Cavinton starting in 1978, with an investigational new drug (IND) application filed in the U.S. in 1981.
Racetams are a family of synthetic compounds targeting brain performance. Piracetam, the primary drug in the category, was developed in Russia and is sold as an over-the-counter (OTC) drug. In 2010, FDA took action regarding Piracetam, indicating the agency did not believe it was a dietary ingredient—and when combined with claims that it affected the structure or function of the body, FDA deemed it to be a “new drug,” not a dietary supplement. Many other racetams continue to be sold as supplements, like phenylpiracetam, omberacetam (Noopept) and more. In sport, only phenypiracetam appears on the WADA Prohibited List as a stimulant; others may be prohibited under catchall language.
Insulin-like growth factor 1 (IGF-1) is both a human hormone and a pharmaceutical drug. It is prohibited in sport, along with other growth factors. It also happens to be naturally present in things like colostrum and deer antler, both sold as supplements. WADA noted, “Colostrum is not specifically prohibited, however it contains certain quantities of IGF-1 and other growth factors which are prohibited and may influence the outcome of anti-doping tests. Therefore, WADA does not recommend the ingestion of this product.” What was not mentioned is that whey protein also contains IGF-1, which is a natural component of milk, cheese and more (Int Dairy J. 2008;18:695-704). Recently, an IGF-1 ingredient extracted from whey protein entered the sports nutrition arena.
To read the article “Pushing the innovation envelope in sports nutrition: How far is too far?” in its entirety—including information about ingredient regulation and past issues with substances such as SARMs and DMAA—check out the “Expanding demographics in sports nutrition” digital magazine.
Oliver Catlin is the longtime president and co-founder of BSCG (Banned Substances Control Group), an international third-party certification and testing provider. With a background in sports anti-doping, Catlin is widely regarded as a thought-leader in the field of sports nutrition and dietary supplements.
Rick Collins, former Nassau County assistant district attorney, is a current partner at Collins Gann McCloskey & Barry PLLC and president of the Nassau County Bar Association. His legal skills and ethics have earned the highest possible accolade, the AV rating by the Martindale-Hubbell directory of lawyers. Collins is also listed in the Bar Register of Preeminent Lawyers.