FDA Finalizes Guidance on How to Determine Whether a Company Meets the “Small Business” Definition under the FSMA Preventive Controls Regulations

The U.S. Food and Drug Administration (FDA) recently finalized its “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507 (CGMP and Preventive Controls Regulations for Human and Animal Food).” The Guidance is intended to help facilities determine whether they qualify as a “small business” for the purposes of Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) regulations. Qualifying as a small business is significant because it may result in 1) exemptions from certain requirements for “farm mixed-type facilities” and 2) later compliance dates (which have already passed, with a few minor exceptions).

Notably, the Guidance explains that different entities within the same corporate structure may have different statuses under the rules (i.e., one entity could qualify as a small business while another does not). This memorandum provides a high-level summary of the Guidance, and we encourage any company claiming status as a small business to read the Guidance closely to confirm it is performing the analysis consistent with FDA’s expectations.

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