FDA announces crackdown on illegal Alzheimer’s supplements and proposes broader reforms

Statement of CSPI President Dr. Peter G. Lurie

No dietary supplement should be marketed as a prevention or a treatment of any disease, least of all Alzheimer’s disease, whose afflicted population would be especially vulnerable to illegal marketing. We commend the Food and Drug Administration for taking enforcement action against 17 companies that were trying to exploit that vulnerability. This is a useful shot across the bow of the supplement industry on the part of the FDA, and there is certainly no shortage of other targets that the agency could pursue. In January 2018, FDA took similar action against supplements marketed as treatments for opioid withdrawal after a complaint from CSPI in December 2017.

It’s encouraging that Commissioner Gottlieb seems open to making changes to the Dietary Supplement Health and Education Act—the deeply flawed law that has long handcuffed the FDA’s regulatory efforts and has produced the sprawling, largely unregulated and often reckless industry we have today. As part of the Commissioner’s initiatives, we strongly support adding a requirement that manufacturers list their products with the FDA, so the agency knows exactly what it’s regulating. It’s clear that the agency needs mandatory recall authority so it can pull tainted supplements off shelves. And DSHEA could be further improved by requiring more meaningful product labeling, with more prominent disclaimers, warnings of drug interactions, and 1-800 numbers for consumers to report adverse events to FDA.

It’s unclear exactly what the Commissioner intends when he references the idea of exclusivity for dietary supplements. In the drug world, exclusivity is usually granted to incentivize manufacturers to innovate through scientific research. With the supplement industry, any ‘innovation’ is clearly in the marketing realm, and not in the scientific realm. In the absence of properly controlled research designed to establish safety and/or efficacy, exclusivity should not even be on the table.

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