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FDA recently responded to a letter from congressional representatives regarding product safety in the dietary supplement industry. In the letter, dated April 12, 2018, the agency states that safety, product integrity, and informed decision-making are the prioritization factors used to determine enforcement and regulatory strategies for the dietary supplement industry which is now a $40 Billion market with up to 80,000 products through a supply chain that includes approximately 7,000 facilities.

The agency stressed that the review of Serious Adverse Events, New Dietary Ingredient notifications, and work with the FTC to remove product and companies from the market that contain undeclared pharmaceutical ingredients and other adulterants when found through inspection, label compliance reviews, and market surveillance is key.

This was sent in a letter to Congressional Representative Andy Harris from MD, Derek Kilmer from WA, and David Young from IA who had previously requested that FDA describe its role and current progress in dietary supplement enforcement and regulation. It is a great glimpse into the current thinking of the Office of Dietary Supplements.

Posted in Dietary Supplements, FDA Update.