FDA Proposes Regulatory Actions on Dietary Supplement Definitions

Food and Drug Law at Keller and Heckman

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2024 Spring Regulatory Agenda Released – Suggests Rulemaking Regarding N-acetyl-L-cysteine

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Wednesday, July 17, 2024

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Earlier this month, the White House’s Office of Information and Regulatory Affairs (OIRA) announced the release of the 2024 Spring Unified Regulatory Agenda. The unified agenda, which is published twice a year, summarizes agencies’ proposed timelines for anticipated regulatory actions, although the timelines are subject to change and are frequently inaccurate, particularly in election years.
FDA’s proposed regulatory actions in the spring agenda include a proposed rule which, “if finalized, would provide by regulation that an ingredient is not excluded from the dietary supplement definition” (0910-AI91). Although the ingredient is not referenced in the regulatory agenda, it is widely believed that the referenced ingredient is N-acetyl-L-cysteine. As we previously reported, FDA previously concluded N-acetyl-L-cysteine was excluded from the definition of a dietary supplement based on its use as a drug but would be subject to enforcement discretion pending a decision on whether to allow for its use through the issuance of a regulation.
Among FDA’s many other proposed actions are a proposed rule regarding front of pack nutrition labeling (0910-AI80); changes to standards of identity (SOI), including a proposed rule to modernize the SOI for maple syrup (0910-AI96) and a proposed rule to modernize the way in which changes to SOIs are considered (0910-AI79); a proposed rule to change certain written assurance provisions in the HARPC rules (0910-AH77); a final rule for the definition of “healthy” (0910-AI13); and a final rule regarding soy protein and coronary heart disease health claims (0910-AH43).
Notable actions on USDA’s regulatory agenda include a proposed rule to establish requirements for labeling of meat or poultry products made using animal cell-culture technology (0583-AD89) and a proposed rule to establish a new framework to reduce Salmonella illness associated with poultry products (0583-AD96).