FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing, Packaging, Labeling, and Holding of Dietary Supplements

On June 18, 2026, the Food and Drug Administration (“FDA”) announced the submission of a proposed collection of information to the Office of Management and Budget (“OMB”) pertaining to the manufacturing, packaging, labeling, or holding of dietary supplements to ensure their quality (“FDA Notice”). Written comments (including recommendations) are due to OMB by July 20, 2026.

The proposal submitted to OMB relates to regulations found at 21 CFR Part 111 that apply Current Good Manufacturing Practices (“CGMPs”) to entities that operate in the dietary supplement space: those who manufacture, package, label or hold dietary supplements; those who manufacture dietary supplements that are packaged or labeled by another; and those who import dietary supplements into the United States. The requirements pertaining to holding dietary supplements do not apply to those holding dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers.

Background

Section 402(g) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. §342(g), allows the Secretary of the Department of Health and Human Services to prescribe CGMPs for dietary supplements. 21 CFR Part 111 imposes extensive requirements relating to, for example, personnel; sanitation regarding physical plant and grounds; design and construction; equipment and utensils; and more. The regulations relate to recordkeeping, documenting, planning, control, and improvement processes of a quality control system. The proposal focuses on recordkeeping requirements as well as 21 CFR 111.75, reflecting FDA’s determination that manufacturers that test or examine 100 percent of the incoming dietary ingredients for identity can be assured of the identity of the ingredient.

Recordkeeping Requirements

The proposed information collection relates to recordkeeping requirements showing:

• what is being manufactured;
• whether the controls in place ensure the product’s identity, purity, strength, and composition;
• whether limits on contaminants and measures to prevent adulteration are effective; and
• whether and what deviations from control processes occurred, with evaluation and corrective action concerning those deviations (including, where necessary, whether associated batches of the product should be recalled) that enable a manufacturer to ensure that the corrective action was effective.

Additionally, the recordkeeping requirements establish written procedures and the maintenance of records pertaining to, among other things:

• personnel;
• sanitation;
• calibration of instruments and controls;
• calibration, inspection, or checks of automated, mechanical, or electronic equipment;
• maintaining, cleaning, and sanitizing equipment and utensils and other contact surfaces;
• water used that may become a component of the dietary supplement;
• production and process controls;
• quality control;
• components, packaging, labels and product received for packaging and labeling;
• master manufacturing and batch production;
• laboratory operations;
• manufacturing operations;
• packaging and labeling operations;
• holding and distributing operations;
• returned dietary supplements; and
• product complaints.

Takeaways

In the FDA Notice, the agency notes that industry has raised concerns as to the cost of complying with these recordkeeping requirements. On February 24, 2026, FDA published a similar 60-day notice and received feedback from one commenter with concerns, including that: 1) the burden estimate may not fully capture the range of compliance costs across firms of differing sizes and operational complexities; and 2) there is a need for flexibility in how records are maintained and reported. Other comments covered the importance of recordkeeping requirements in the absence of premarket approval requirements; the risk of diminishing marginal returns without increasing safety or effectiveness; and the suggestion for a more risk-based and performance-oriented approach to recordkeeping to better align regulatory burden with actual public health objectives.

There are two important notes from the information gathering as indicated by FDA: first, the FDA notice recognizes that there may be circumstances when 100 percent identity testing for dietary supplement ingredients is not necessary; and second, FDA suggests that there may be flexibility as to how records are maintained. But regarding the cost of compliance, the FDA Notice provides no direct commentary. Rather, it provides a “Table 1,” setting forth the estimated annual recordkeeping burden in terms of total hours required for compliance by the industry (929,140 hours total). While the costs of compliance with the recordkeeping requirements are significant, FDA is declining to put monetary estimates on these requirements or to scale them back.

FDA makes clear that the recordkeeping regulations do not specifically prescribe the use of specific techniques or technology and that “companies are free to use whatever forms of information technology may best assist them in recordkeeping and reporting.”

Stakeholders should submit their own written comments via this link under “Currently under Review—Open for Public Comments.” The OMB Control Number is 0910-0606 and the FDA docket number, which should be included, is FDA-2026-N-0686.

Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.