FDA Proposes Regulatory Action on Definition of Dietary Supplements

Spring 2024 Regulatory Programme Published – Suggests Development of N-Acetyl-L-Cysteine Regulations

Wednesday, July 17, 2024

Earlier this month, the White House Office of Information and Regulatory Affairs (OIRA) announced the release of the Spring 2024 Regulatory Agenda. The agenda, which is released twice a year, summarizes agencies’ proposed timelines for anticipated regulatory actions, although these timelines are subject to change and are often imprecise, especially during election years.
FDA’s proposed regulatory actions in the spring program include a proposed rule that “if finalized, would provide by regulation that an ingredient is not excluded from the definition of a dietary supplement” (0910-AI91). Although the ingredient is not listed in the regulatory program, it is generally believed that the listed ingredient is N-acetyl-L-cysteine. As previously reported, FDA previously determined that 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 to allow its use by issuance of a regulation.
Among the FDA’s many other proposed actions are: a proposed rule on front-of-package nutrition labeling (0910-AI80); changes to the standards of identity (SOI), including a proposed rule to modernize the SOI for maple syrup (0910-AI96) and a proposed rule to modernize the manner in which changes to the SOI are considered (0910-AI79); a proposed rule to revise certain provisions related to written assurances in the HARPC rules (0910-AH77); a final rule on the definition of “healthy” (0910-AI13); and a final rule on health claims related to soy protein and coronary heart disease (0910-AH43).
Notable actions in the USDA regulatory program include proposed regulations establishing labeling requirements for meat or poultry products produced using animal cell culture technology (0583-AD89) and proposed regulations establishing a new framework to reduce Salmonella poultry products disease (0583-96 AD).