FDA Announces Plans for Modernizing and Reforming Dietary Supplement Oversight and Issues Batch of Warning Letters Over Unlawful Alzheimer’s Claims

The Food and Drug Administration (FDA) recently announced a plan for “policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.” FDA Commissioner Scott Gottlieb reflected on the 25th anniversary of the Dietary Supplement Health and Education Act, and stated his commitment to ensuring FDA achieves the right balance between consumer access to lawful supplements, while upholding the agency’s public health obligation to protect consumers from unsafe and unlawful products, and holding unlawful actors accountable. The announcement sets lofty goals and teasers for details that are forthcoming.

FDA also articulates several priorities for modernizing and reforming its oversight of dietary supplements, as discussed further below. As a part of these efforts, the agency issued over a dozen Warning Letters to companies marketing products as dietary supplements but that were labeled with unapproved disease claims, such as claims about the prevention of Alzheimer’s disease.

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