The U.S. Food and Drug Administration (USFDA or FDA) is a federal agency under the United States Department of Health and Human Services.

It is an executive department within the U.S. government. Therefore, the top position within this department (the Commissioner of Food and Drugs) is appointed by the President.

The FDA controls the protection and promotion of public health through the supervision and regulation of pharmaceuticals, tobacco products, food safety, vaccines, medical devices, cosmetics, animal feed, and many other products that fall into the category of human consumption (whether directly or indirectly.)

In addition to regulating materials manufactured domestically, the FDA also manages any items imported into the U.S. that fall under the following categories:

  • Human Foods
  • Human Drugs
  • Vaccines, Blood and Biologics
  • Medical Devices
  • Radiation-Emitting Electronic Products
  • Cosmetics
  • Animal and Veterinary
  • Tobacco Products

Special certifications are needed to import many, but not all, of the items that fall into these categories. For example, not all cosmetics require FDA approval to be imported. As long as the items are properly labeled, unadulterated, and do not contain forbidden color additives and/or drug or food products, they can be imported without FDA pre-approval or certifications. Furthermore, items such as sunglasses, lens frames, spectacle lenses, and magnifying glasses are considered medical devices but are exempt under Premarket Notification 510(k) from submission to the FDA. This means that these “devices” are compared to similar approved materials and based on their similarities are granted approval within 90 days to be marketed within the U.S. Although these items are 510(k) exempt, additional regulations do apply:

  • The manufacturer (whether domestic or foreign) and distributor (importer) must register their establishment with the FDA.
  • Manufacturers must list the materials with the FDA.
  • Manufacturers must meet quality requirements.
  • The lenses and/or sunglasses must be certified as impact resistant under specific FDA codes.

Chemicals or items that contain harmful color additives, Mercury compounds, Bithionol, or Chloroform (to name a few), are prohibited or restricted by the FDA. If these items are imported without prior notice and the proper certification, they will be seized and refused FDA import approval.

The FDA does specify the difference between personal shipments and commercial items to be introduced into the U.S. market, but both classes may be subject to FDA approval depending on the substance being imported.

All FDA-regulated products must undergo a review process.

Entries are first submitted to U.S. Customs and Border Patrol (CBP) who will then refer them to the FDA for further review – high risk products or those with incomplete or inaccurate information are marked for manual review and follow-up. The FDA will then check the compliance history of the importer, ensure the importer is approved for the materials they are importing, and then decide if the item is approved or denied entry into the U.S. If a product is denied, the importer has 90 days to destroy the material or export it out of U.S. territory.

If a company is established with the FDA for one product, it does not necessarily mean they are able to import any product regulated by the FDA. The certification process is specific to the product and not the company. A company established to import sunglasses for retail use cannot also import talcum powder (for commercial or personal use) unless the substance has already been approved to them prior to importation.

For more questions regarding FDA-regulated materials, certifications, and requirements, please contact MTS logistics through the portals on our website.