What is the FDA? 

The FDA, or the Food and Drug Administration, is the federal agency most responsible for ensuring that food, drugs, cosmetics, and other related items are safe, clean, and correctly labeled for human and pet consumption. As of January 2024, it has overseen the safety of over $3.6 trillion worth of food and medical products both in the US and abroad. 

What does the FDA Regulate?

The FDA is important because it regulates about 90 different industries. Those industries include, but are not limited to:

• Biologics
• Food
• Cosmetics
• Vitamins
• Human Drugs
• Veterinary Products
• Medical Devices
• In-Vitro Diagnostics
• Non-Medical Radiation-Emitting Products. 

It covers about 78% of the US food supply, with notable exclusions being meat, poultry, and some egg products, and it has approved over 20,000 prescription drugs for marketing. 

It is worth mentioning that in nearly every case, FDA-regulated goods require special or expanded filing when entering the US. The best way to know what you need is to check with your Customs broker before you ship. We have the expertise and specialist knowledge you need to ensure a smooth and straightforward crossing. 

What does the FDA Not Regulate?

The FDA is largely concerned with the safety and efficacy of foods and products that fall under its jurisdiction. What it is not generally concerned with is the advertising of products unless that product is making claims that have not been evaluated by the FDA. This gray area can cause some clearance problems, but generally, they are not concerned with advertising.

The FDA does not regulate alcohol, consumer products, illegal drugs, or health insurance. It’s easy to make this mistake given the agency’s proximity to those things, but the lines are very intentionally kept clear. Similarly, as mentioned above, the FDA does not deal with meat, poultry, and some egg products, and despite what might seem like a logical link - it also has no relationship with restaurants or grocery stores. 

FDA Food Facility Registration

Food facilities that manufacture, process, pack, or hold foods must register as an FDA food facility. These facilities must maintain a physical presence, or appoint a US agent if they do not have a US physical presence, for the purposes of reregistering your facility. Businesses that maintain these facilities must re-register every even year, and reregistration is mandatory (2026, 2028, 2030, etc.) For this process, you can register at any point between October 1st and December 31st of that year. The consequence of failing to be registered with the FDA is that you will be unable to import any product regulated by the FDA. 

FDA Education

For more information about the commodities regulated by the US FDA, the requirements needed to clear FDA-regulated goods across the border, and the types of FDA reviews that can occur, we invite you to join one of our regular educational sessions at the PCB Learning Center, covering this topic in depth.

Alternatively, you can get in touch with one of our Trade Advisory team today for bespoke expertise on your specific situation. We have decades of experience working with FDA-regulated goods and the people who import them, and we can help you ship quickly, effectively, and headache-free. 

We look forward to helping you in any way that we can, so don’t hesitate to get in touch today!