Harmonized Tariff Schedule
When entry is made for FDA-regulated products, importers or their customs broker/entry filer will include the Harmonized Tariff Schedule (HTS) code in the entry submission. The HTS codes are flagged with indicators to help guide whether FDA data is required. Visit the entry submission process page for more information on submission process for FDA-regulated products.
The Harmonized Tariff Schedule (HTS or HTS Code) is a classification code used to provide the applicable tariff rates and statistical categories for all merchandise imported into the United States. It is based on the International Harmonized System, which is the global classification system that is used to describe most world commodities. To determine your HTS code, search on the US International Trade Commission HTS page.
If you have questions about the FD flag on an FDA regulated commodity, please contact the Division of Import Operations: by phone 301-796-0356 or email FDAImportsInquiry@fda.hhs.gov.
The HTS code for your product will most likely be associated with an FD flag. This flag acts as an indicator to the customs broker/entry filer that your product needs to be transmitted to FDA for review.
Not all HTS codes have FD flags; for example, products not regulated by FDA, such as textiles would not have an FD flag. This does not mean that the product is not FDA-regulated. Customs brokers/entry filers, based on their knowledge of the intended use of the product, may still transmit FDA data for HTS codes that do not have an FD flag. For FD1 or FD3 lines, a customs broker/entry filer must either submit and supply prior notice as required or disclaim the entry depending on the intended use of the product.
The following is a list of the FD flags and their meanings:
|FD1||May or may not be regulated by FDA: If regulated by FDA, submit entry information; if not regulated by FDA, disclaim||Certain chemicals used in manufacturing drug products vs. industrial use; safety goggles for medical use vs. non-medical use|
|FD2||Regulated by FDA, but is not food: Submit entry information||Medical Devices, Drugs, Tobacco, and Cosmetics|
|FD3||May or may not be a food product: If yes, submit Prior Notice (PN) and entry information; if no, disclaim||Salt used for flavoring food vs salt used for treating road surfaces|
|FD4||Food product: Submit PN and entry information||Fish and seafood, live food animals, dairy products, shell eggs, fruits, vegetables, food and feed ingredients, food and feed additives, infant formula, beverages (including alcoholic beverages and bottled water), bakery goods, snack foods, candy, canned foods, and dietary supplements and dietary ingredients|