FDA Announces Public Meeting to Solicit Comments on Regulation of Dietary Supplements
Friday, April 12, 2019
- The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Food, Drug, and Cosmetic Act to create the current regulatory framework for dietary supplements. At the time the law was passed, there were roughly 4,000 dietary supplements on the market in the United States. The number of dietary supplements on the market is now estimated to be between 50,000 and 80,000. Under DSHEA, producers of dietary supplements with new dietary ingredients must provide the Food and Drug Administration (FDA) with a premarket notification at least 75 days before introducing the product to market.
- Despite the increase of dietary supplements on the market of more than ten times what was on the market when DSHEA was passed 25 years ago, FDA has only received around 1,200 notifications for new dietary ingredients. While not all new dietary supplements include new dietary ingredients, FDA believes the relatively low number of notifications is due, in part, to an ineffective regulatory practice. As a result, on February 11, Dr. Scott Gottlieb, the then Commissioner of FDA, announced a new plan for dietary supplement oversight. As noted in the Daily Intake blog at the time, FDA has five steps it will implement:
- Develop new ways to communicate more quickly when FDA is concerned that an ingredient is unlawful and potentially dangerous and should not be marketed in dietary supplements.
- Ensure that the regulatory framework for dietary supplements is flexible enough to adequately evaluate product safety while promoting innovation.
- Undertake more collaborative research with industry.
- Continue to take actions to protect public health and develop new enforcement strategies.
- Establish public dialog on whether additional steps are necessary to modernize DSHEA.
- FDA announced in the April 11 Federal Register a May 16 public meeting to solicit input on regulation of dietary supplements in furtherance of the new plan for dietary supplement oversight. During that meeting, FDA hopes to discuss the following topics:
- The scope of the phrase “dietary substance for use by man to supplement the diet by increasing the total dietary intake”,
- Exceptions to the requirement for premarket notification and whether and how growth in the dietary supplements marketplace since 1994 has altered the impact of DSHEA,
- Potential commercial or marketing advantages to incentivize responsible innovation, and
- Promoting overall compliance with the premarket notification requirement through enforcement
- Registration to attend in person at FDA’s College Park campus is due by May 6. The meeting will also be streamed on webcast, though registration is required for the webcast as well.
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