What single issue is most likely to cause legislators, detractors and celebrities to unite against the industry and its products? It has all the hallmarks of a bad joke. It hasn’t made headlines in about 10 months or so, but it never goes away – at least in our current environment. I’m speaking of course about the relationship between our industry and the elite/professional sports community, which unfortunately, has made headlines again..
Latest on this subject is the suspension of Philadelphia Phillies J. C. Romero for testing positive for a performance enhancing product. The sports press is filled with perspective on the story, and the product, 6-OXO-Extreme from ErgoPharm. Advertising states that the product is intended for “maximum testosterone production”. I can’t help but wonder why a professional athlete familiar with the league’s policies about performance enhancing products (one of the most obvious tests in elite athletes, at least, is for testosterone itself) wouldn’t shy away from this type of product. In fact, in describing the credentials of the company’s chemist, the website describes Patrick Arnold as “an organic chemist credited with the introduction of prohormones or “andro” products”. Shouldn’t this have raised an alarm?
Sources say that Romero tested positive for Androstenedione, which, according to the original company statement, could have been a false positive because of testing methods. (A later statement indicated the mechanism for testosterone boosting was different). Whatever the case or mechanism, the unfortunate irony is that the issue quickly turned from players seeking any edge and industry outliers willfully creating designer products, to a criticism of DSHEA (http://www.philly.com/philly/business/37782489.html), with industry detractors like CSPI quickly into the fray. The law, they argue, allows these products.
As it turns out, the above article does go into a discussion of the new ingredient pre-market notification process with FDA (NDIs) and probably most ludicrous of all, is the company arguing that the 6-OXO compound is a legitimate DSHEA grandfathered ingredient, not because it was found in the food supply and existed pre-1994, but because it was found in the tissue of slaughtered cattle and sheep.
This gross mis-application of the law exists in an environment where industry has provided feedback on an NDI Guidance document proposed by FDA, and where industry has repeatedly called for FDA to take on outliers and those abusing the regulations and FDA’s gross lack of resources. A critical statement in the article about this situation is when FDA was asked whether they have ever tried to block supplement-makers from marketing new dietary ingredients despite its objections. The FDA spokesperson responded, “To date, FDA has not taken an enforcement action against any such product.” With such incentive to flout current rules and regulations, is it any wonder that companies get rich by designing and creating such products?
Maybe the biggest irony of the Romero case is that rather than creating an environment where Ergopharm is more likely to have its products and practices scrutinized, this story has likely caused a massive increase in product sales and the further growth of the sub-culture which drives the extreme sports nutrition space. Talk about misplaced incentives!
So how did this story become about DSHEA? Well, as is usually the case, the law itself is described as a document intended to promote self-regulation (almost impossible when one considers outliers such as Ergopharm), describing DSHEA as a ‘loose’ leash. And this leash quickly acquires the trappings of a noose as the sports community has the ability to exercise its influence on legislators and the media.
While there are those that may argue that this industry has too many trade associations, and that even within them, there is political expediency and compromise, perhaps the time has come for a gauntlet to be laid down. Although anti-trust laws would have an issue, perhaps it’s time for companies to be defined as in our industry, only if they belong to an acknowledged industry trade association.
For until we have a legitimate rationale and a mechanism for educating all who care as to what is and is not our industry, this is still our problem.