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The industry has seen an increase in FDA scrutiny, causing confusion about the FDA’s guidance on the strengths and composition of finished dietary supplement products and ingredients. Though there has been no change in regulation, FDA has expressed “concern” that botanical ingredients are not uniformly distributed throughout product batches and wants to see that testing, dictated on the product specification, is conducted to ensure this uniformity. This is a long-standing issue for all companies, big and small. Get a diverse perspective from industry experts and learn how to navigate this conversation with FDA.
Manufacturers of dietary supplements play a key role in consumer safety. If an adverse event associated with a dietary supplement occurs, the manufacturer is responsible for documenting and thoroughly investigating the issue. As for serious adverse events reports (SAERs), manufacturers are obligated to document and submit any such reports that meet the law’s definition of “serious” to the U.S. Food & Drug Administration (FDA) in a timely matter. Failure to submit SAERs to FDA has consequences.
In November 2022, the CITES Conference of the Parties (CoP19) met in Panama City, where proposals to add new botanical species (including all species of Rhodiola spp.) to CITES Appendix II were accepted. Under CITES Appendices, 30,000 flora species are protected to ensure the international trade of plant species is not threatened. View this webinar to learn more about CITES, including: hstory of CITES and relevance to the natural products industry; what is entailed when a botanical gets listed with CITES; process for compliance if you are importing CITES-listed botanicals; AHPA resources on CITES.
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