SPOTLIGHT: FDA and BALCO
Question: Hasn't the FDA gotten aggressive against supplements lately?
Answer: After a decade of playing possum, the FDA has suddenly changed its strategy regarding nutritional supplements. Rather than complaining that the Dietary Supplement Health and Education Act of 1994 (DSHEA) tied their hands from policing supplements, the FDA folks are now taking an active role. They recently banned ephedra supplements and androstenedione and have a new "umbrella strategy" that includes a draft guidance for dietary supplement claims, finalization of good manufacturing practices (GMPs) and development of new policies to focus on product safety.
For supplements that were on the market prior to the 1994 law, a new "signal detection" process, using information from various sources, will be used to identify safety issues. It is- and should be- FDA's job to ensure that products that pose significant or unreasonable safety risks stay off the market. However, given the long-standing distrust and lack of cooperation between the FDA and industry, we can only hope the process will be enforced fairly.
Of particular concern is that the FDA's primary targets are the "new dietary ingredients" (NDIs) that were not marketed prior to DSHEA. Many popular sports supplements contain NDIs. DSHEA requires certain notifications to the FDA about safety or history of usage prior to marketing some NDIs. However, the provisions as to which NDIs require pre-market notification and as to what information needs to be conveyed are so unclear that many sports supplements were marketed without the notifications. The FDA recently held a public meeting to begin to develop a guidance clarifying what the law requires, at which my law firm presented a submission with recommendations from our community. It is yet to be determined what guidelines will be implemented, or whether the sports nutrition products on the market today will soon be banned by the FDA for failure to have filed pre-market notifications. Don't be surprised if some of the FDA's decisions under the new guidance are viewed as biased against industry and consumers.
Question: What will be the fallout of the BALCO scandal?
Answer: Since the leaked grand jury testimonies and recent "20/20" interview, politicians are threatening to pass further anti-steroid legislation. While we can hope that this time they get it right, past experience suggests otherwise. Remember that back in 1988, a similar media frenzy erupted when sprinter Ben Johnson tested positive for steroids at the Seoul Olympics. Just like now, politicians lamented the loss of a "level playing field" and so they passed a law in 1990 making non-medical possession of steroids a crime.
Touted amid great fanfare as the solution to steroids in sports, it was a failure. In the 14 years since the law went into effect, I can't think of a single professional ballplayer or Olympic athlete who was ever busted and jailed for steroids. The people who have been busted for steroids are thousands of non-competing, average gym rats who were using these substances not to cheat other athletes, but simply to look better without a shirt on. The black market has ballooned, users are afraid to see their doctors and most of the products are now foreign veterinary drugs. Some solution.
Over the past two years, politicians acknowledged the chronic problem of drugs in sport, but now blamed prohormone supplements and some loopholes in their 1990 law. So, they held more hearings and passed a new law in October, 2004, again with the idea of solving the problem. That law hadn't even gone into effect when already the politicians started threatening a new one.
Knee-jerk legislative responses and talk about "saving the children" from steroids can grab headlines and comfort an uneducated public, but actually solving the problem remains a distant dream. Given the history, what we'll see over the next few years is likely to be more ineffective laws, more steroid arrests of recreational bodybuilders, and the unabated continuation of sophisticated cheating in elite athletics. That's reality
Question: Hasn't the FDA gotten aggressive against supplements lately?
Answer: After a decade of playing possum, the FDA has suddenly changed its strategy regarding nutritional supplements. Rather than complaining that the Dietary Supplement Health and Education Act of 1994 (DSHEA) tied their hands from policing supplements, the FDA folks are now taking an active role. They recently banned ephedra supplements and androstenedione and have a new "umbrella strategy" that includes a draft guidance for dietary supplement claims, finalization of good manufacturing practices (GMPs) and development of new policies to focus on product safety.
For supplements that were on the market prior to the 1994 law, a new "signal detection" process, using information from various sources, will be used to identify safety issues. It is- and should be- FDA's job to ensure that products that pose significant or unreasonable safety risks stay off the market. However, given the long-standing distrust and lack of cooperation between the FDA and industry, we can only hope the process will be enforced fairly.
Of particular concern is that the FDA's primary targets are the "new dietary ingredients" (NDIs) that were not marketed prior to DSHEA. Many popular sports supplements contain NDIs. DSHEA requires certain notifications to the FDA about safety or history of usage prior to marketing some NDIs. However, the provisions as to which NDIs require pre-market notification and as to what information needs to be conveyed are so unclear that many sports supplements were marketed without the notifications. The FDA recently held a public meeting to begin to develop a guidance clarifying what the law requires, at which my law firm presented a submission with recommendations from our community. It is yet to be determined what guidelines will be implemented, or whether the sports nutrition products on the market today will soon be banned by the FDA for failure to have filed pre-market notifications. Don't be surprised if some of the FDA's decisions under the new guidance are viewed as biased against industry and consumers.
Question: What will be the fallout of the BALCO scandal?
Answer: Since the leaked grand jury testimonies and recent "20/20" interview, politicians are threatening to pass further anti-steroid legislation. While we can hope that this time they get it right, past experience suggests otherwise. Remember that back in 1988, a similar media frenzy erupted when sprinter Ben Johnson tested positive for steroids at the Seoul Olympics. Just like now, politicians lamented the loss of a "level playing field" and so they passed a law in 1990 making non-medical possession of steroids a crime.
Touted amid great fanfare as the solution to steroids in sports, it was a failure. In the 14 years since the law went into effect, I can't think of a single professional ballplayer or Olympic athlete who was ever busted and jailed for steroids. The people who have been busted for steroids are thousands of non-competing, average gym rats who were using these substances not to cheat other athletes, but simply to look better without a shirt on. The black market has ballooned, users are afraid to see their doctors and most of the products are now foreign veterinary drugs. Some solution.
Over the past two years, politicians acknowledged the chronic problem of drugs in sport, but now blamed prohormone supplements and some loopholes in their 1990 law. So, they held more hearings and passed a new law in October, 2004, again with the idea of solving the problem. That law hadn't even gone into effect when already the politicians started threatening a new one.
Knee-jerk legislative responses and talk about "saving the children" from steroids can grab headlines and comfort an uneducated public, but actually solving the problem remains a distant dream. Given the history, what we'll see over the next few years is likely to be more ineffective laws, more steroid arrests of recreational bodybuilders, and the unabated continuation of sophisticated cheating in elite athletics. That's reality