Statement by Steve Mister, President and CEO:
“Rogue products that contain anabolic steroids are not dietary supplements, regardless of how the bad actors who manufacture and market these products might position them—they are illegal, unapproved new drugs. Responsible supplement companies do not condone these practices, and urge the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) to use the ample authority already granted to these agencies to crack down on anabolic steroids that put athletes and young people at risk.
Under the Controlled Substances Act, Congress has given the DEA special power to regulate anabolic steroids. Just because a rogue manufacturer may misrepresent the product as a dietary supplement does not undermine the DEA’s legal authority to pursue these illicit substances. Under the Dietary Supplement Health and Education Act (DSHEA), it is also illegal for supplements to contain drugs or undeclared substances, and FDA has the regulatory authority under existing law to take action against companies manufacturing and marketing unapproved drugs masquerading as dietary supplements. FDA can remove these products from the marketplace if they pose an imminent threat to public health or if there is a significant or unreasonable risk of injury or illness associated with use of the products.
Further, under DSHEA, all new dietary ingredients (NDIs) must go through the NDI notification process before they enter the market—if they do not, then the products are considered adulterated. Anabolic steroids and steroid precursors in particular, would be subject to this notification requirement especially if not already illegal under the Controlled Substance Act, and FDA can take enforcement action against companies that fail to notify the Agency. Enforcement tools available to FDA include seizure of products, and fines and criminal sanctions against companies that ignore the law—FDA just needs the resources and the political will to use them.
All industries struggle with a few outliers and the supplement industry is no exception. However, the vast majority of the industry follows the law and makes quality products that play an important role in consumers’ health and wellness. DSHEA appropriately protects consumers and responsible manufacturers and gives the Agency the appropriate authority to handle those who skirt the law.
We cannot ignore the fact that there is a societal problem that pushes some competitive athletes to adopt a ‘win at all costs’ mentality, resulting in their seeking out questionable products that will give them a leg-up on their competition. This leads to a demand side that helps to drive the supply problem. We support FDA’s efforts to crack down on individual companies that are manufacturing illegal and unapproved drugs and urge athletes to be aware of the rules of their athletic governing bodies and to choose their supplements wisely.”