Video | U.S. FDA Requirements For Regulated Goods

What Is The FDA?

The Food and Drug Administration (FDA) is a federal agency of the United States which ensures food is safe, clean and correctly labeled for human and pet consumption.

What Does The FDA Regulate?

The FDA regulates over 90 industries. Most commonly they regulate biologics, food, cosmetics, vitamins, human drugs, veterinary products, medical devices, in-vitro diagnostics, and non-medical radiation emitting products.

What Does The FDA Not Regulate?

What the FDA does not regulate is advertising of products, alcohol, consumer products, illegal drugs, health insurance, meat, poultry, pesticides, restaurants and grocery stores.

How To Get FDA Regulated Products Across The Border

FDA Food Facility Registration

Any food facility who manufactures, processes, packs or holds food must register as an FDA food facility. You must have a physical presence in the U.S. for purposes of registration. Biennial Re-registration is required every even year (2016, 2018, 2020 etc.).  You are able to re-register from October 1st to December 31st, and you must be registered to be able to import any product regulated by the FDA.

FDA Video

A short video explaining the commodities regulated by the U.S. FDA, requirements to clear FDA regulated goods across the border and the types of FDA reviews.

To assist importers in becoming aware of their requirements and implications of regulations involved with importing FDA regulated goods into the USA, Pacific Customs Brokers regularly hosts FDA related seminars and webinars. Visit the Trade Compliance Education section of our website to see a list of seminars and webinars currently being offered. For more information on how Pacific Customs Brokers can help you commercially import food products into the USA, please contact us.

New Requirements Imposed As FDA Proposes Two New Rules