FDA Regulations

Smithers Pira has extensive experience with FDA regulations and can assist in helping our clients understand and meet FDA requirements.

The USA Food and Drug Administration Service (FDA) first started regulating Food Contact materials in 1958 and since then has developed a wide-ranging set of regulations covering most classes of food packaging materials. The regulations can be found in the Code of Federal Regulations (CFR) Chapter 21 Sections 170 to 199.

How we can help?
Smithers Pira has extensive experience with these regulations and can help you:
  • Show that your products comply by auditing your formulations and carrying out any end tests.
  • Notify your new substances using the Food Contact Notification Program.
What do FDA Regulations do?

FDA regulations typically clear the final chemical composition of a material, such as a paper or a polymer resin, so the chemicals listed in a particular regulation are specific to that material. This means, for example, that additives listed for polyethylene in 177.1520 cannot necessarily be used in PET, unless they are also listed in 177.1630, or, have a more general clearance elsewhere in the regulations such as in Section 178.

Where restrictions exist they are compositional in nature. Extraction tests, called end tests, may be required for a particular material. These tests are designed to show that your product is not grossly dissimilar to the material that was originally approved by the FDA.

Understanding the FDA regulations is complicated by what the FDA does not regulate. These exemptions include prior sanction, substances generally recognized as safe, the basic resin doctrine, no migration exemption, functional barriers, threshold of regulation and the housewares exemption.

Can coatings and adhesives are treated differently from other materials because they are often very complex and have no easily defined chemical composition. For can coatings 175.300 lists starting materials and intermediates and anticipates the reaction that makes the coating, however, monomers not listed may be used provided they react to form intermediates that are listed. Similarly adhesive components are listed in 175.105 and once again it is assumed that these will react to form the finished adhesive. Additionally, 175.105 only clears substances when a functional barrier is present or for very low exposure at seams and edges.

For a complete understanding of how the FDA regulates Food Contact substances it is also necessary to understand the Food Contact Notification (FCN) Program - see Food Contact Notifications for more details. Each FCN gives a proprietary approval for a Food Contact substance in a particular application that can only be used by the notifying company and its customers. No regulations are brought forward to cover the substances approved in FCN's.