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FDA In Brief: FDA issues guidance to help importers, food producers implement FDA Food Safety Modernization Act rules

For Immediate Release: Jan. 24, 2018

Media Inquiries

  Juli Putnam
  240-402-0537

"We’re committed to helping food importers and manufacturers meet the new requirements for imported food mandated by the FDA Food Safety Modernization Act,” said Dr. Stephen Ostroff, deputy commissioner of the FDA’s Office of Foods and Veterinary Medicine. “Our ultimate goal is to keep food – both imported and domestic – safe for Americans, and importers and manufacturers play key roles by helping to ensure the safety of their food products."

The U.S. Food and Drug Administration today published several guidance documents to help importers and food producers meet key food safety provisions mandated by the FDA Food Safety Modernization Act (FSMA). Together, these documents will provide a foundation of support for importers and food producers working to ensure that their suppliers are in compliance with the applicable food safety standards.

Two of these documents, a draft guidance and a small entity compliance guide (SECG), will help industry meet the requirements of the FSMA Foreign Supplier Verification Programs (FSVP) regulation, a 2015 rule making importers accountable for verifying that the food they import meets U.S. safety standards. The draft guidance released today provides the FDA’s current thinking on how best to comply with the FSVP requirements while the SECG offers specific guidance for small businesses that are required to comply with the FSVP rule.

A third draft guidance addresses the term “same level of public health protection” that is used in both the FSVP regulation and the Produce Safety regulation.

The fourth guidance is another chapter in the draft guidance that the FDA has been issuing in sections to help food processors and manufacturers comply with the regulation implementing FSMA’s requirements for hazard analysis and risk-based preventive controls for human food, and is designed to help food facilities comply with the supply-chain program requirements.

These guidance documents represent the latest steps the FDA is taking to prevent foodborne illness by ensuring food producers understand and effectively implement FSMA, legislation that was signed into law in 2011 that aims to strengthen the food safety system and better protect public health.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.