FDA jurisdiction depends on the product and its intended use. The fact that a shipment is small, low value, promotional, a sample, or shipped by parcel carrier does not by itself remove FDA requirements.
Common product groups regulated by FDA
- Human food and beverages
- Dietary supplements
- Cosmetics
- Human drugs, including many over-the-counter products
- Medical devices
- Radiation-emitting electronic products
- Animal food, animal drugs and other veterinary products
- Tobacco products
- Certain food-contact articles, including cookware, containers and ceramicware
Do not rely on the HTS code alone
An HTS code is a customs classification. FDA uses its own program, product code, intended-use and compliance data. The HTS code can be useful as a screening signal, but the product description, composition, claims, intended use and regulatory status still need to be evaluated.
Examples
- A face cream may be a cosmetic, a drug, or both depending on its claims and intended use.
- A ceramic cup is not food, but it may fall within FDA's food-contact/ceramicware entry requirements.
- A laser pointer is not a medical device but is a radiation-emitting electronic product regulated by FDA.
If the regulatory status is unclear, obtain a detailed product description, ingredients/materials, label images, claims, manufacturer information and intended use before filing.