The FDA Compliance Simplified team has the privilege of working with companies from all over the globe. So not surprisingly, our clients frequently have import-related questions. Unfortunately, some folks ask questions only after the product has been shipped and detained in customs. We pulled the following list of steps for our food, pet food, and dietary supplement clients from FDA import information so you can avoid that mistake. These basic steps generally apply to importation of cosmetics as well but the good manufacturing regulations will be different once FDA gets around to writing them.

Be sure to follow these steps before shipping FDA-regulated products to the U.S.

  1. Review FDA Food Safety and Good Manufacturing Practice regulations to ensure that the facilities that manufacture or warehouse your products can comply with them. Note: the next step, facility registration, puts the facility on FDA’s inspection list.  (Dietary supplement GMPs can be found here.)
  2. Register the facility where the products are produced and held.  (See cosmetic registration information here.)
  3. You must have a program to assist your importer of record in complying with the Foreign Supplier Verification Program that they will have to put together.
  4. If your product is a liquid or gel and preserved by either a) having a low pH or b) being thermally processed, then you need a second facility registration that includes your processing steps for FDA review and approval prior to shipping product to the US. (Note: FDA uses the term ‘canned’ food to refer to any shelf stable product that has liquid or gel content.)
  5. You must ensure that your product ingredients are permitted in the U.S. Unfortunately, there is not a single source of information for this one. Feel free to contact us with questions.
  6. You must ensure that the product label is in compliance with FDA regulations. There are a lot of nuances in this step and FDA’s food labeling guide is very much out of date. Please contact us with questions.
  7. You must notify the FDA of your shipments so then can be inspected upon import.

NOTE: This list only covers FDA’s side of importing food products into the U.S. U.S. Customs and Border Protection has other regulations that are outside of our expertise. We recommend that you work with a reputable Customs Broker to ensure compliance with those other import regulations.

I hope you find this information helpful. Let me know if you have any questions.