Pew Recommends That FDA Pursue Dietary Supplement Safety Reforms

FDA Should Pursue Dietary Supplement Safety Reforms

The Pew Charitable Trusts wrote on May 3 to Janet Woodcock, acting commissioner of the U.S. Food and Drug Administration, recommending steps to improve the agency’s oversight of vitamins, herbs, fish oils, hormones, and other dietary supplements. The majority of adults take supplements, which are marketed for uses including improved nutrition, weight loss, and athletic and sexual performance. In the past two decades, the agency and researchers have found drugs and other illegal ingredients in hundreds of these products. And in a 2019 Pew survey, 7 in 10 adults said that under current law, the agency cannot protect Americans from unsafe supplements.

Pew specifically urged Commissioner Woodcock to:

  • Support a new requirement that manufacturers provide FDA with basic information about all supplements they sell, including their ingredients and labels—a policy known as mandatory product listing.
  • Ensure that FDA can mandate recalls of supplements tainted with active pharmaceutical ingredients—an authority that agency officials have previously asserted they lack.
  • Improve enforcement of requirements that manufacturers alert FDA about new dietary ingredients they plan to market, which provide regulators an opportunity to review the safety and proposed uses of these substances.

These tools and policies would enable FDA to know which products and ingredients are available to consumers and to more swiftly remove illegal and harmful supplements from the marketplace.

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Congress Should Prioritize Dietary Supplement Reform as Part of Its Efforts to Strengthen Public Health
Congress Should Prioritize Dietary Supplement Reform as Part of Its Efforts to Strengthen Public Health
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Congress Should Prioritize Dietary Supplement Reform

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Fact Sheet

The U.S. Food and Drug Administration regulates these products under the 1994 Dietary Supplement Health and Education Act, but the agency cannot effectively nor efficiently protect public health because of significant gaps in this outdated law.