FDA and FSMA Regulations

Visit the FDA Food Safety Modernization Act (FSMA) home page

FDA Update – March 20, 2018:

FDA has issued a new draft guidance to make it easier for companies to determine if they fit the small business definition of Food Safety Modernization Act’s (FSMA) Preventive Controls (PC) rules for human and animal foods.

View the Draft Guidance Document

FDA Update – January 13, 2017:

As of January 13th, 2017, the Food and Drug Administration (FDA) announced the availability of a revised draft guidance entitled “Control of Listeria monocytogenes in Ready-To-Eat Foods.” The revised draft guidance is intended for any person who is subject to the “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” and who manufactures, processes, packs, or holds ready-to-eat (RTE) foods. The revised draft guidance is intended to help these entities comply with the requirements of the final regulation with respect to measures that can significantly minimize or prevent the contamination of RTE food with L. monocytogenes whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes.

Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals:

Please click here to read some notes of clarification for questions regarding FDA’s Sanitary Transportation waivers released the week of April 3, 2017. 

As of May 11th, the FDA has released a constituent update on FSVP.

The U.S. Food and Drug Administration has updated FDA.gov to include updated fact sheets, and new guidance as a resource for importers subject to the FSVP rule, which makes them responsible for verifying that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.

FDA FSVP Fact Sheet

Fact Chart: Am I Subject to FSVP?

FSVP Compliance Dates

Training Materials from FSPCA

Questions? Contact the FSMA Technical Assistance Network

FDA Fact Sheets:

The FDA has provided factsheets and flowcharts on the FSMA webpage for each rule.  These documents are an entry point to understanding who is covered under each rule.

Links to flowcharts and  key facts:

https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472891.pdf
https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472461.pdf
https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472499.pdf

Click here to read some Frequently Asked Questions on FSMA