Recently, the U.S. Food and Drug Administration (FDA) issued a consumer advisory on “certain products marketed for sexual enhancement that have been found to contain hidden ingredients and might pose a significant health risk.” Most of the seven identified products are illegally marketed as dietary supplements despite containing illegal drug ingredients. These occasional consumer announcements from FDA are both ineffective for consumers and infuriating to the legitimate, mainstream dietary supplement industry.
If FDA is issuing a consumer notice for these products, why isn’t it simultaneously announcing a mandatory recall of them? All of them are apparently marketed on Amazon, so did the agency demand those sellers be removed from the platform? If they contain undisclosed, potentially dangerous prescription drugs, these products are both adulterated and misbranded dietary supplements, and unapproved and potentially harmful new drugs. FDA has ample legal authority to enforce the law and protect consumers on either grounds. And yet, a review of FDA’s Warning Letter website does not even indicate that FDA has sent warning letters to the companies involved—much less inflicting any real legal consequences on the people putting consumers’ safety at risk.
FDA recently announced a reorganization of its Human Foods Program that proposed to eliminate the Office of Dietary Supplement Programs. When industry objected, the Commissioner insisted that the elimination of the Office would not lead to any diminution in the attention, resources or priorities being directed to dietary supplements at the Agency. Actions like today’s beg the question: When is FDA going to increase its attention to this $60 billion industry and the three-quarters of Americans who use dietary supplements and expect FDA to have their backs by supporting safe, quality products as the law provides. FDA’s indifference and neglect on these matters are exactly why industry is worried about losing any stature it has in the Agency.
But despite the lack of enforcement, FDA doesn’t hesitate to invoke anxiety among supplement users. In its announcement (and on its Health Fraud Product Database), FDA states “This list only includes a small fraction of the potentially hazardous products marketed to consumers online and in retail establishments. Even if a product is not included in this list, consumers should exercise caution before using certain products.” I can think of no other regulated category that gets this kind of routine disparagement from FDA. Imagine this: “Hey, consumers, we found one food that has salmonella, but everything else is potentially contaminated too, so use caution with anything you eat.”
The dilemma FDA faces is this: on the one hand, dietary supplements are among the safest regulated products that it oversees. Compared to the vast number of supplements ingested by Americans, they have relatively few serious adverse events, negative side effects or serious poison control center incidents. By comparison to drugs, and even food, supplements have a strong track record of safety. So based on a risk prioritization model, they get little attention from the agency. But on the other hand, FDA is still smarting from 1994 when the Agency lost its bid in Congress to regulate the products more like pharmaceuticals. It still wants more authority over dietary supplements, and fear mongering, along with lax enforcement of the existing requirements, may eventually give the Agency the additional authority it wants despite the safety track record.
It’s time FDA reconciled these realities and accepted that consumers want access to safe and beneficial products without excessive regulation. FDA should implement and enforce the existing law, and that includes aggressively targeting companies who put illegal and dangerous erectile dysfunction. ingredients into products and peddle them as “all-natural” dietary supplements. Responsible supplement producers and consumers don’t want an impotent Agency, they want to know the products they take for better health and wellness are being regulated as the law requires. NIE
Steve Mister is the president & CEO of the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry.