“The funding outlined in this year’s FDA budget request is critical to fulfilling the agency’s mission as we continue our work on a wide range of COVID-19 and non-COVID priorities," saidnewly confirmedFDA Commissioner Robert M. Califf, M.D., in a news release. "The FDA has focused our budget request on some of today’s most urgent needs such as human and animal food safety, medical device security and e-cigarette oversight. We also continue to look ahead at our role in public health, including at ways to modernize our efforts to keep pace with evolving science, technology and potential public health emergencies. Additional funding brings new ways to leverage opportunities to protect and advance the health of every American with reliable and science-based information. We look forward to continuing our work with Congress to help meet the critical public health challenges ahead.”
FDA explained that, to complement the funding requests its budget proposal includes legislative proposals "designed to bolster the FDA’s authorities to further its mission to protect and promote public health." This includes a proposal to modernize dietary supplement regulation. FDA is seeking to require annual listing with the FDA of individual dietary supplement products, including basic information about each unique product. FDA also is seeking to clarify its authorities over marketed dietary supplement products "to better facilitate enforcement against unlawfully marketed products, allowing the FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market and take appropriate action to protect consumers."
Industry associations weighed in on FDA's proposal.
American Herbal Products Association (AHPA) President Michael McGuffin:"With the release of its FY23 budget request and summary documents, FDA has stated its desire to have Congress modernize dietary supplement regulation by amending the Federal Food, Drug, and Cosmetic Act to impose a mandatory product listing (MPL) requirement. AHPA also has interest in potential regulatory modernization, provided that it actually benefits consumers. To this end, there remain many unaddressed concerns about MPL proposals— including that any MPL requirement could destabilize the balance that the Dietary Supplement Health and Education Act [DSHEA] struck between informed consumer access and appropriate FDA authority. With the goal of modernizing regulation while retaining this balance, AHPA advocates for the removal of obstacles to the dissemination of truthful and not misleading information to consumers. AHPA similarly advocates for amendments to the prior drug exclusion provision to establish a more-reasonable pathway to market for all natural products, even if that means that certain ingredients would eventually exist in both the pharmaceutical and dietary supplement markets."
Natural Products Association (NPA) President and CEO Daniel Fabricant, Ph.D.:“FDA’s proposal to include mandatory product listing in their FY23 budget request is a non-starter. Year after year, FDA receives more funding, including a $2 million increase in FY22. Yet, despite these increases, FDA consistently does less with more. Mandatory product listing is pre-market approval disguised as transparency and would only add to the bureaucratic nightmare the industry is experiencing withNACandCBD. Instead of framing the dietary supplement industry as a regulatory crisis, FDA should recognize the importance of dietary supplements to the health and wellness of American consumers, as evident by the nearly 80% who use our products.”
Related: Calls to Action 2022 Mandatory Product Listing: Beneficial, or Burdensome?
Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville: “FDA’s recent request for a 34% budget increase in FY2023 shows that new FDA Commissioner Robert Califf recognizes the critical importance of self-care in public health. FDA’s budget aligns with CHPA’s priorities to empower self-care by ensuring Americans continue to have access to safe, reliable, and affordable personal healthcare products including over-the-counter medicines, consumer medical devices, and dietary supplements. “Specifically, we’re pleased to see FDA’s proposed budget also prioritizes modernization of dietary supplement regulation by supporting mandatory product listing, increasing inspection capacity, and clarifying its authority to better facilitate enforcement against unlawfully marketed products. This budget proposal makes it clear that Dr. Califf views stronger oversight of dietary supplements as a key part of FDA’s mission to advance the health and wellbeing of every American. We look forward to working with FDA and Congress as they map out the path forward for FY2023 and continue to empower consumer self-care.”This article will be updated as more information and insights become available.