Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability

What it does

• •FDA announces a draft guidance stating it will not enforce traceability record requirements under the Food Traceability Rule for retail food establishments and restaurants with average annual food sales between $250,000 and $1,000,000 (adjusted for inflation).
• •The guidance clarifies that FDA is exercising enforcement discretion for this middle-tier business category, which falls between the fully exempted small businesses (≤$250,000) and larger establishments subject to full compliance.
• •The draft guidance does not create legal rights or bind FDA or the public; entities may use alternative approaches if they comply with applicable statutes and regulations.

Why it matters

• •Regulated entities in the retail food and restaurant industries identified compliance challenges for small businesses not eligible for the existing $250,000 exemption, prompting FDA to provide regulatory relief for a larger segment of small-to-mid-sized businesses.
• •The enforcement discretion policy clarifies FDA's current risk-based approach to implementing the Food Traceability Rule issued under the FDA Food Safety Modernization Act.

Who is affected

• •Retail food establishments and restaurants with average annual food sales between $250,000 and $1,000,000 over the prior 3-year period (adjusted for inflation).
• •Entities subject to the Food Traceability Rule requirements in 21 CFR Part 1, Subpart S.

What happens next

The public may submit comments on the draft guidance until November 23, 2026, after which FDA will develop a final version of the guidance.