An article that appeared last week in USA Today has raised again the issue of sports products and the presence of banned substances. The study, performed by UK-based HFL Labs and aggressively promoted in sensationalist style by the US group Informed-Choice, claims that 25 percent of supplements are contaminated with steroids.
There are at least three aspects of this news that have raised the ire of industry at the recent course of events, first, the accreditation status of HFL, second, the blinding of companies and products in the published version of the ‘study’, and third, from the analytical community, questions about the level of validation and therefore confidence in the analytical results themselves.
In my blog (http://www.npicommunity.com/Blogs/tabid/53/BlogID/2/Default.aspx) I’ve commented on a couple aspects of this story, including a bit of background about WADA accredited labs, as well as my personal distaste for the sensational and misleading presentation of these results. On the former issue, if there were better relationships between industry and the sports community, industry would probably know a lot more about the WADA accreditation process. In fact, come to think of it, if there were better relationships, there would be a much more open discussion about lab methods, state of validation, complex matrices etc.
The fact that HFL and Informed-Choice have totally blinded the results makes the study impossible to refute. And the damage has been done with another black eye, but perhaps more importantly, a step back in consumer and specifically athlete and sport community confidence in supplements as the world prepares for the Beijing Olympics. In the overall scheme of things, this latest ‘study’ will likely not cause that much damage, in a market sense, to the business of the industry. There will be no drop in sales, no disgruntled customers who will look at this latest adverse publicity, and say, that’s it, I’m done with supplements. On the corporate side, if Informed-Choice has their way, a flock of companies will sign up for the new certification program, to see their products, and their lots, posted on the Informed-Choice website for consumers and athletes to view and make buying decisions. And HFL of course gains business with every lot of product tested, pass or fail.
There are other, less significant outcomes to a story such as this. Legislators, we have learned to our chagrin, pay a lot of attention, as does the medical community. Of course the sports community does and the rhetoric involved in calling for prohibition of all supplements to athletes gets dialed up a notch (and this just when coaches and trainers are grudgingly admitting some supplement benefits). And of course, the lightning rod of these issues is sports supplements to high school athletes, and so the call to place supplements behind the counters and out of the reach of anyone under 18 gets ratcheted up. Labels and precautions begin to be considered. And this lack of confidence and risk aversion makes its way into the minds of mainstream consumers, the very consumers that industry must reach in order to really become a mainstream health solution.
But GMPs will help the situation, won’t they?
In fact, fundamentally, I’m not so certain. Sure, they’ll allow industry to say that most of the products are manufactured in the proper environment while cleaning procedures should theoretically prevent the alleged cross contamination in manufacturing, and better sourcing procedures and quality control of incoming raw materials should prevent poor quality contaminated ingredients from being acquired. Both these statements are true and both should be operational in shoring up industry’s quality reputation.
Here’s where not knowing the products and companies involved in the latest study begins to manifest. Are the companies HFL and Informed-Choice allege to have failed their testing mainstream or sports nutrition focused manufacturers? Are they using contract manufacturers? Is the incidence of failure predominantly certain classes of products? To what extent is DHEA involved? (DHEA is classified as a banned substance by WADA, while exempted under the Steroid Control Act of a few years ago, allowing it to remain on the market as a supplement). And the real crux of the ‘testing for sport’ dilemma: Would high quality ingredient or finished product testing for normal compliance purposes, have come close to detecting the presence of these steroid residues? It is this very argument that prevents companies from engaging in many of the sport certification programs – Their products are compliant for general purposes, why pay extra for additional testing when there is no incremental ROI?
As the phase in period for US GMP compliance approaches, it is reasonable to expect most companies in our industry to comply. Already we’re seeing a bit of an increase in third party certifications, and the dialogue between suppliers and manufacturers has continued to evolve. Once fully implemented, one argument for industry detractors will be partially removed and this should help industry challenge negative results such as the Informed-Choice presented findings. In the absence of agency enforcement of GMPs, the manufacturing problem will not be totally eliminated. Therefore third-party certification could be a wise practice, at least for fundamental GMPS, if not for sports certification.
In the past though, at least in part, it is products certified through other programs that have been a target for HFL as it seeks to grow its own share of the testing market. Stay tuned…….