The Food and Drug Administration regulates 75 cents of every dollar spent on consumer goods, including the vast majority of foods, human and veterinary drugs, vaccines and other biological products, medical devices intended for human use, radiation-emitting electronic products, cosmetics, dietary supplements, and tobacco products. Each regulated commodity is subject to specific regulations that importers should be aware of. The FDA has jurisdiction over imported products from growing, harvesting, manufacturing, or processing, through the entry process, and after the products have entered U.S. commerce.
All products offered for entry into the U.S. must be declared to U.S. Customs and Border Protection. The most common entry type for FDA-regulated products is a consumption entry, which is used when products are imported for use in the U.S. and are going directly into U.S. commerce without any restrictions of time or use. Consumption entries can be informal, if the shipment's value does not exceed $2,500, or formal, if the value is more than $2,500. Other entry types include immediate transportation, transportation and exportation, temporary importation under bond, and foreign-trade zone. Products may only be entered by their owner or purchaser or a licensed customs broker.
When entry is made for FDA-regulated products, importers or their brokers will include the Harmonized Tariff Schedule number in the entry submission. HTS numbers for FDA-regulated goods are generally (but not always) flagged with indicators to help guide whether FDA review is required.
When the product is FDA-regulated (regardless of whether or not so indicated by the HTS number), specific information must be submitted to the FDA for review. This information describes what the product is, where it came from, when it will arrive, and its quantity and value. The FDA also wants to know the product’s manufacturer, shipper, importer, and recipient. Affirmation of compliance codes may also be submitted (and are required in some instances) to indicate that the product meets applicable requirements. Timely, accurate, and complete information expedites the FDA’s admissibility decision process.
The FDA reviews entries to ensure that the products comply with all applicable requirements, but it is important to note that the importer of record is responsible for making sure this is the case. The FDA’s review may include a request for more information or an examination or sampling of the product. During this review the imported product should not be distributed into U.S. commerce until the FDA has determined its admissibility. If it is and an FDA exam is needed, CBP will request that the product be returned to the port of entry.
The FDA may refuse entry to regulated products if its review determines that they violate or appear to violate any provisions of FDA laws (including the Federal Food, Drug, and Cosmetic Act; the Public Health Security and Bioterrorism Preparedness and Response Act; and the Food Safety Modernization Act). This includes products that are or appear to be adulterated (contaminated, unsafe, unapproved, or does not otherwise meet applicable standards), misbranded (labels contain false or misleading information or the product is not registered and listed if required), or forbidden or restricted for sale.
Once products are found to be violative, future shipments of those products from that manufacturer (and possibly other entities such as importers of record or shippers) have the appearance of being violative and are also subject to refusal. These products are detained without physical examination by the FDA and listed on an import alert, which informs FDA staff across the country that there is sufficient evidence that the product is violative and can be refused entry. The FDA currently maintains more than 200 import alerts, and it is the responsibility of the importer of record of listed goods to prove they are in compliance with FDA laws and regulations.
The importer of record is allowed to offer evidence to refute violations. They may also ask for FDA approval to recondition the products to bring them into compliance, such as by relabeling a misbranded product or cleaning an adulterated product.
If the FDA refuses entry of a product, it must be destroyed or exported from the U.S. within 90 days. Failure to do so may result in liquidated damages assessed by CBP against the import bond. Violative products may also be subject to other enforcement actions, including seizure by CBP or FDA, civil monetary penalties, bond actions, state embargo/stop sale orders, food importer debarment, and prosecution.
For more information on these topics, please contact FDA consultant Domenic Veneziano (at (202) 734-3939 or via email) or attorney Andrea Jeglum (at (781) 559-0140 or via email).
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