Are Your Goods Subject to FDA? | Trade Risk Guaranty

What is the FDA?

The Food and Drug Administration (FDA) is a federal agency within the United States Department of Health and Human Services agency. They are responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. They also ensure the safety of our nation’s food supply, cosmetics, and products that emit radiation.

What Products are Subject to FDA Regulations?

In the most basic terms, the Food and Drug Administration regulates anything placed in or on the body. Products regulated by the FDA include:

Human foods, including dietary supplements and color additives

Human drugs

Vaccines, blood, and biologics

Medical devices

Radiation-emitting electronic products

Cosmetics

Animal & veterinary food and medicines

Tobacco products

Import Process for FDA Products

To determine if your commodity is subject to FDA, check the HTS commodity code for an FDA flag. The four types of FDA flags are:

FD1, meaning the product may or may not be regulated by the FDA depending on its use.

FD2, meaning it is regulated by the FDA but is not food.

FD3, meaning it may or may not be a food product depending on its use.

FD4, meaning it is explicitly a food product.

If your commodity is subject to FDA regulations, you will need to provide the following information to U.S. Customs and Border Protection (CBP) when filing for entry. All entries are first submitted to CBP, who will then refer all entries of FDA-regulated products to the FDA for review and examination.

Commodity and subtype

Product code

Product description

Country code identifying where the product was produced, sourced, or harvested

Names and addresses of the manufacturer, shipper, and importer

Contact information

Estimated arrival date and time

Affirmation of Compliance

Quantity and value of goods

Certain products may require additional or less information than others, so it is essential to use the Food and Drug Administration’s supplemental guides for further instructions. For example, many FDA products require prior notice that is non-negotiable to make entry. When prior notice is required, it is because the FDA needs time to determine if the commodities need further inspection upon arrival.

When the Food and Drug Administration receives your entry information, it is electronically screened to assess risk. High-risk products and entry submissions with incomplete or inaccurate information are flagged for manual review to determine the admissibility of the product.

After the review process, the FDA will release your product to be distributed into U.S. commerce, request additional information, or request detention of the product. They will request additional information if the information in the electronic entry is not sufficient to make an admissibility decision. They will review shipping and entry documents and sometimes examine or collect samples of the product for further analysis to determine admissibility. Suppose the FDA requests detention of your product. In that case, it could be due to the product or manufacturer being subject to detention without a physical examination or because compliance with particular requirements cannot be verified.

FDA goods are denied entry if they seem to be or have been discovered to be contaminated, meaning the goods:

Are unsafe

Are unauthorized

Do not meet acceptable standards

Have improperly marked labels containing inaccurate or misleading information

Are not registered and listed

Are forbidden and restricted from sale

Importers have two options if an entry is denied:

Destroy the product under FDA and CBP supervision

Export the product under FDA and CBP supervision

This must occur within 90 days of the refusal notice. If the importer fails to do so, CBP may assess liquidated damages against their Customs bond.