Key takeaways

  • The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products.
  • FDA regulation involves enforcing laws and regulations, ensuring the safety, quality, and efficacy of medications, foods, cosmetics, and medical devices.
  • FDA regulation and approval are not the same thing. Before being marketed, a product’s benefits must outweigh its risks for the intended use (the approved use). Only new drugs, complex medical devices, and color additives require FDA approval.

Do you ever wonder what the Food and Drug Administration (FDA) regulates? The FDA is a federal government agency that enforces laws and regulations to ensure the safety, quality, and effectiveness of many everyday products, including medications, foods, and cosmetics.

Here’s a summary of products the FDA regulates and approves.

The FDA regulates all medications and many medical devices. Keep in mind that FDA regulation is not the same as FDA approval. FDA approval means the FDA analyzed research data about the product and determined that its benefits outweigh its risks for the intended use (the approved use).

The FDA approves new drugs and some medical devices. A new drug or medical device must be approved by the FDA before the manufacturer can market it for human use.

Medications

The following list includes medications that the FDA regulates before and after they’re marketed:

The FDA also runs the approval process for medications that contain controlled substances, which are substances the federal government regulates due to the risk of misuse or dependence. However, the Drug Enforcement Agency (DEA) is responsible for enforcing U.S. laws and regulations for controlled substances.

Note: The FDA does not evaluate the safety, quality, or effectiveness of compounded drugs. However, it can issue safety guidance to the public if concerns arise.

Medical devices

Some, but not all, medical devices are subject to FDA approval. The FDA classifies devices based on their benefits and risks:

  • High risk devices, such as heart pacemakers, require FDA approval before use.
  • Moderate risk devices, such as catheters, require FDA clearance based on evidence that the product is equivalent to a preexisting device.
  • Low risk devices are regulated but don’t require formal FDA clearance or approval.

Examples of medical devices the FDA regulates include:

  • simple items, such as oral swabs and exam gloves
  • blood glucose monitors
  • dental devices and implants
  • surgical implants and prosthetics, such as an artificial knee joint

The following list includes examples of foods and beverages the FDA regulates:

This list does not include all of the foods the FDA regulates. For example, the U.S. Department of Agriculture (USDA) is the lead regulatory body for certain meat and egg products.

Did you know?

The FDA approves color additives, such as dyes, for use in food products regulated by the FDA, including human and animal foods, dietary supplements, and cosmetics.

If you’ve ever bought cosmetic or skin care products, you’re probably aware of the long list of ingredients you can’t pronounce. It’s nice to know the FDA regulates the safety and quality of these products, including:

  • makeup color additives
  • shampoo
  • skin care products, such as moisturizers, facial cleansers, and serums
  • nail beauty products and polishes
  • perfumes

You may not know that the FDA also regulates radiation-emitting devices. These include:

Similar to medications for people, the FDA also regulates certain products for use in animals, including:

  • veterinary drugs and devices
  • livestock feeds
  • pet foods

The FDA regulates tobacco products but does not approve them for sale. Rather, it evaluates new tobacco products based on the risks and benefits to the population, including people who do not use them (for example, the effects of secondhand smoke). The FDA then determines whether to authorize the product for sale in the United States.

Examples of FDA-regulated tobacco products include:

The FDA regulates all medications, except for compounded drugs. It also regulates medical devices, radiation-emitting electronic devices, foods and cosmetics, veterinary products, and tobacco.

FDA regulation is not the same thing as FDA approval. By law, most medications and certain medical devices are subject to approval. If the FDA determines, based on the available research, that the benefits outweigh the risks, it can approve the product.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.