FDA Regulations

The USA has a wide-ranging set of food contact regulations covering most classes of food packaging materials; these regulations can be found in the Code of Federal Regulations (CFR) Chapter 21 sections 170 to 199.

It is imperative for companies to meet FDA food contact regulations if they intend to sell their goods in the US market.

We can help you:

  • Identify which submission route will help you gain FDA clearance for your material, whether via the Food Contact Notification (FCN) program, a Food Additive Petition (FAP) or through the Threshold of Regulation Exemption (ToR)
  • Demonstrate compliance by auditing your formulations
  • Carry out any end tests that are required (also known as extraction tests)
  • Notify your new substances using the Food Contact Notification (FCN) program
  • Understand the complex exemptions not regulated by the FDA, and undertake migration testing to assess whether your material is suitable for a no migration exemption


The Smithers difference:

  • Experts who keep up-to-date with regulatory changes, and who are regular speakers at world-leading conferences and training course leads
  • Our experts have been helping clients demonstrate food contact regulatory compliance since 1985