FDA-regulated products imported into the U.S. must comply with FDA laws and regulations. FDA enforces the Federal Food, Drug and Cosmetic Act (FD&C Act) and other related acts. This page provides an overview of FDA’s import compliance and enforcement activities at the point of entry.
FDA has jurisdiction over imported products at the time of entry but also after the products have entered domestic commerce.
For more information on what FDA regulates visit FDA Basics.
Below is a list of actions, enforcement and compliance activities that FDA may take:
- Examination & Sample Collection
FDA is authorized to examine and collect samples of FDA-regulated products offered for entry into the U.S. If the FDA decides to examine or sample your products, a Notice of FDA Action will be issued to the importer of record, consignee, and filer. It is your responsibility to notify the FDA office handling your entry that your products are available for examination. The FDA office handling your entry is identified on the Notice of FDA Action. Once the location of your products is provided, FDA will arrange to examine the products. Products pending FDA examination or sample collection must be held and should not be distributed into commerce until results are evaluated and the products are released. Failure to hold your products might result in FDA requesting Customs and Border Protection (CBP) to demand redelivery.
- Detention & Hearing
If the product appears to be in violation, the product is subject to refusal and a Notice of FDA Action will be issued. The notice will specify the nature of the violation and provide the importer an opportunity to present supporting evidence to overcome the violation, within a specified time period. The importer can request an extension if additional time is needed to collect or present the information.
Import alerts inform FDA field staff that the agency has enough evidence or other information to allow for Detention Without Physical Examination (DWPE) of products subject to an import alert. Products are subject to DWPE based upon past violations. These violations could be related to the product, manufacturer, shipper and/or other information indicating the product may be in violation of FDA laws. Depending on the specific import alert, products can still be imported into the U.S. if the importer has demonstrated that the product is in compliance. Before shipping to the U.S., importers should be aware of whether or not the product is subject to DWPE. Additionally, import alerts:
- Prevent potential violative products from being distributed into the U.S.
- Free up agency resources to examine other products
- Provide uniform coverage across the country
- Place the responsibility back on the importer. (It is the responsibility of the importer to ensure that the products being imported into the U.S. are in compliance with FDA laws and regulations.)
FDA has more than 200 active import alerts that prevent potentially violative products from entering U.S. commerce.
- Import Refusals
FDA-regulated products can be refused entry into the U.S. if they do not meet FDA's laws and regulations. The reason for refusal includes but is not limited to products that appear to be:
- adulterated, meaning the product is contaminated, is not safe, or does not otherwise meet applicable standards;
- misbranded, meaning the labels contain false or misleading information;
- an unapproved new drug;
- forbidden or restricted for sale.
The above list is not intended to be a complete list of the reasons FDA-regulated products are refused entry. For information on specific products which have been refused, you can view the FDA Import Refusal Report (IRR).
- Filer Evaluations
FDA conducts filer evaluations on a routine basis to determine if an entry filer is submitting data accurately. Evaluations are conducted by examining entry documents and comparing the information against data submitted electronically to FDA. Filer Evaluation results are publicly available on the internet and the information is updated monthly.
- Other Enforcement Actions
Additionally, imported products and firms found to be in violation of FDA laws and regulations may also be subject to other enforcement actions including but not limited to seizure by Customs and Border Protection (CBP) or FDA, civil money penalties, bond actions, state embargo/stop sale, food importer debarment, and prosecution.