Food safety (FSMA)

The Federal Food, Drug and Cosmetic Act (FFDCA) requires that human food and animal feed be safe for consumption, be prepared in sanitary conditions, be free from harmful substances, and be properly labeled. The Food Safety Modernization Act (FSMA) focuses the burden of ensuring food safety on the prevention of contamination. The Center for Food Safety and Applied Nutrition (CFSAN), a branch within Food and Drug Administration (FDA) is responsible for regulating food ingredients, additives, packaging materials, contact substances, and foodstuff products that enter the country. The Center for Veterinary Medicine (CVM) regulates animal feed.

Food additives and food contact substances are subject to premarket approval by FDA unless they are generally recognized as safe (GRAS) by qualified experts. To ensure the safety of packaging materials and manufacturing equipment, companies must submit a food contact notification (FCN) along with sufficient data to CFSAN.

Food importers are responsible for verifying that their foreign suppliers have sufficient preventive controls in place to ensure food safety. FDA has the right to deny entry of food from manufacturers that have denied FDA inspectors access to their food production facilities. FSMA also established a Foreign Supplier Verification Program (FSVP) to facilitate imports from registered producers. U.S. based companies that export food to other countries are responsible for following both U.S. laws and regulations, as well as the requirements for countries to which goods are being exported.

TSG can help

  • Prepare and submit Food Contact Notifications (FCN)
  • Prepare and submit food additive petitions
  • Prepare and submit GRAS notification
  • Create dietary exposure models
  • Review ingredients
  • Submit establishment registration
  • Act as a U.S. agent
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