How to Enforce the Law—and Really Mean It

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June 15, 2022  | Join the conversation on LinkedIn

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By Steve Mister, President & CEO, CRN

Yesterday, I had the opportunity to speak at the FDLI Annual Conference on a panel examining dietary supplement regulation. The FDA representative offered that the agency is examining how it could become more effective and more efficient in its regulatory oversight of dietary supplements.

The agency has a long way to go. As an example, the FDA recently issued a batch of warning letters asserting that certain ingredients it has identified in supplements are not lawful dietary ingredients. As other industry critics have pointed out, some of these same ingredients have been the subject of numerous warning letters to other companies in the past—and the behavior never changes.

Why isn’t FDA’s enforcement activity working?

I had a few suggestions, which I want to share here:

First, FDA needs to articulate more clearly what constitutes illegal conduct and also must be prepared to stand behind its position. Too often, a company receives a warning letter stating that, in FDA’s opinion, a particular claim is a disease claim, or an ingredient is not permissible because it is an unnoticed NDI, or it is precluded by prior use in a drug. The warning letter is then released to the public, but it is never resolved, no close-out letter is issued, and the matter never proceeds to the point of being a “final agency action.”

We’re left wondering—was the conduct illegal or not? Did the company persuade FDA that its initial legal position was incorrect? Did the firm acknowledge its conduct was illegal and correct it? If the agency doesn’t provide clarity on how the matter was resolved, other companies will not look at that action as precedent or a cautionary tale for their own behavior. And without proceeding to a point that the agency’s viewpoint is a “final agency action,” the offending company can’t challenge that viewpoint in court. The agency’s assertions of potential illegal activity just hang there in the ether.

Second, FDA should put its money where its mouth is and pursue meaningful legal action when it believes the statute has been violated and public health is put at risk. Once a warning letter or import alert is issued, FDA should be prepared to pursue the illegal conduct with a legal action if the conduct is not corrected. If that means getting the Department of Justice or a local U.S. attorney involved to pursue the case, the agency should have an arrangement with DoJ that these cases will get priority so that a clear deterrent message can be sent to offenders. FDA needs to use the ample enforcement tools DSHEA provides, including prosecution for illegal conduct if the circumstances warrant.

Third, FDA must seek and pursue strong consequences for illegal conduct. The only way to deter illegal conduct is to change the calculus that criminals construct so that the consequences outweigh the chances of not getting caught or escaping without punishment. As any parent knows, you need to impose punishments that alter the balancing act which occurs when a misdeed is about to be committed—what are the chances of being caught and the consequences if I am? Do those risks outweigh the potential for ill-gotten gains?

Fourth, FDA should leverage the retail community to multiply the impact of its enforcement. If retailers know what products and claims are illegal and which manufacturers habitually fail inspections, they will exercise their own enforcement by removing products from their inventory. If there are consequences for selling clearly illegal products, retailers will think twice. And their own efforts to curate their store shelves (or online platforms) will exponentially increase the consequences of FDA’s own enforcement.

Finally, FDA needs to educate the public about its own legal authority over the dietary supplement market. CRN’s communications team could dedicate a full-time staff position just playing truth squad to the false narrative that “dietary supplements are not regulated.” FDA hasn’t exactly helped dispel that misinformation. As long as FDA allows that misimpression to fester, it encourages new players to explore the marketplace assuming it is a “wild west” where they can make a quick buck and get out. FDA should vigorously and continuously promote the fact that it can and does regulate the dietary supplement industry and that there are consequences for bad actors.

These are just a few constructive suggestions for FDA to “up” its enforcement powers without even having to change the law. I’m sure there are other ways to maximize FDA’s enforcement capabilities.

What are your recommendations?

Steve Mister has been President & CEO of the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement industry, since 2005. Under his leadership, CRN has experienced increased membership each year, doubled its annual budget, sharpened its strategic focus to advance the industry, and launched new initiatives that increase industry responsibility and provide consumer education. During Mr. Mister’s tenure, CRN has been instrumental in enacting the adverse event reporting law for dietary supplements, the Designer Anabolic Steroid Control Act, and defeating several efforts in Congress that would have over-regulated dietary supplements, limiting consumer access. Mr. Mister led the association to launch the Supplement OWL, an industry-run online registry of dietary supplements and their labels. He is a member of the U.S. Chamber of Commerce’s Association Committee of 100, holds a Certified Association Executive (CAE) distinction, and is active in ASAE. Learn more about Steve.