FDA regulated items

The scope of FDA’s regulatory authority is very broad. FDA’s responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following is a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list.

In general, FDA regulates:

Foods, including:

  • dietary supplements
  • bottled water
  • food additives
  • infant formulas
  • other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products)

Drugs, including:

  • prescription drugs (both brand-name and generic)
  • non-prescription (over-the-counter) drugs

Biologics, including:

  • vaccines
  • blood and blood products
  • cellular and gene therapy products
  • tissue and tissue products
  • allergenics

Medical Devices, including:

  • simple items like tongue depressors and bedpans
  • complex technologies such as heart pacemakers
  • dental devices
  • surgical implants and prosthetics

Electronic Products that give off radiation, including:

  • microwave ovens
  • x-ray equipment
  • laser products
  • ultrasonic therapy equipment
  • mercury vapor lamps
  • sunlamps

Cosmetics, including:

  • color additives found in makeup and other personal care products
  • skin moisturizers and cleansers
  • nail polish and perfume

Veterinary Products, including:

  • livestock feeds
  • pet foods
  • veterinary drugs and devices

Tobacco Products, including:

  • cigarettes
  • cigarette tobacco
  • roll-your-own tobacco
  • smokeless tobacco

For more up to date information click on the following links:

Regulated items : https://www.fda.gov/industry/import-basics/regulated-products

Import basics for FDA: https://www.fda.gov/industry/import-program-food-and-drug-administration-fda/import-basics

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