How Will FDA Assembling the Botanical Safety Consortium Affect Your Company’s Botanical Ingredients?

Faegre Drinker Biddle & Reath LLP

Faegre Baker Daniels

Earlier this year, former Commissioner Gottlieb identified new efforts by the Food and Drug Administration (FDA) to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight. To further this goal, FDA announced on November 14, 2019, that a Botanical Safety Consortium has formally been convened. This step is possible because of agreements between FDA, National Institutes of Health’s National Institute of Environmental Health Sciences, and Health and Environmental Sciences Institute. (See, a Memorandum of Understanding (MOU) that was recently signed between FDA, the National Institutes of Health’s National Institute of Environmental Health Sciences, and the Health and Environmental Sciences Institute (HESI)).

Importantly, this Consortium provides FDA with “a forum for scientists from government, academia, consumer health groups, industry and nonprofit organizations to work collaboratively to generate a sound scientific basis for integrating existing safety data and the latest toxicology tools to evaluate botanical safety in dietary supplements” according to FDA’s announcement. With the MOU now executed, FDA will establish specific guidelines for membership and participation in the BSC by early 2020.

This is an important step for FDA in addressing the current and ever increasing number of botanical ingredients found in dietary supplement products. FDA has identified various ingredients that do not appear to be lawfully marketed. FDA continues to issue public announcements and take measures to remove potentially unlawful ingredients from the market. The Consortium provides FDA with another tool to address the safety of dietary supplement ingredients.

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Faegre Drinker Biddle & Reath LLP

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