The FDA regulates a surprisingly broad slice of American life: food, prescription and over-the-counter drugs, medical devices, vaccines and blood products, cosmetics, tobacco, dietary supplements, veterinary products, and even electronics that emit radiation. Altogether, FDA-regulated products account for roughly 20 cents of every dollar U.S. consumers spend.
Food (but Not All of It)
The FDA oversees the safety of most food sold in the United States, including packaged goods, produce, seafood, dairy, bottled water, and food additives. What it does not cover is meat, poultry, and certain egg products, which fall under the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). The dividing line can get oddly specific: a spaghetti sauce without meat is an FDA product, while a spaghetti sauce with meat is a USDA product. Some facilities make both and operate under dual jurisdiction.
The FDA sets standards for food labeling, enforces limits on contaminants, inspects food manufacturing facilities, and manages recalls when contaminated products reach store shelves. It also regulates infant formula, food colorings, and substances added to food during processing.
Dietary Supplements
This is one of the biggest gaps in FDA authority that catches people off guard. Under the Dietary Supplement Health and Education Act (DSHEA), the FDA does not approve dietary supplements before they go on sale. Manufacturers don’t have to prove their products are safe or effective before marketing them, and they generally don’t have to share their safety evidence with the FDA at all. The agency often doesn’t even know when a new supplement hits the market.
The FDA can take action after a product is already being sold if it turns out to be unsafe or mislabeled, but it cannot require pre-market approval the way it does for drugs. It also does not approve the claims that appear on supplement labels, with limited exceptions for certain health claims that require pre-market review.
Prescription and Over-the-Counter Drugs
Every prescription drug and over-the-counter medication sold in the U.S. must go through FDA review. For new drugs, this means clinical trials demonstrating safety and effectiveness before the agency grants approval. The FDA also oversees generic drugs, ensuring they perform the same way as the brand-name versions they replicate.
Once a drug is on the market, the FDA monitors safety reports and can require label changes or pull a product if new risks emerge. One notable detail: the FDA also has direct authority over prescription drug advertising, making it the agency that polices those TV commercials for medications. For nearly every other product category, advertising falls under the Federal Trade Commission, while the FDA handles labeling.
Medical Devices
The FDA has classified roughly 1,700 types of medical devices into three risk-based categories. Class I covers low-risk items like bandages and tongue depressors, which face the least regulatory scrutiny. Class II includes moderate-risk devices like powered wheelchairs and pregnancy tests, which must typically demonstrate they’re substantially similar to a device already on the market. Class III is reserved for the highest-risk devices, things like pacemakers and implantable defibrillators, which require a full pre-market approval process with clinical data.
The FDA is also expanding its reach into laboratory-developed tests, the diagnostic tests created and used within a single lab. A 2024 rule is phasing these tests under the same oversight as other diagnostic devices over a four-year rollout that began in mid-2025, starting with safety reporting requirements and eventually requiring pre-market review for high-risk tests.
Vaccines, Blood, and Biologics
Biological products go through their own approval pathway at the FDA. This category includes vaccines, blood and blood components for transfusion, gene therapies, and cellular therapies. These products are evaluated for safety, purity, and potency before they can be administered to patients. The FDA also regulates the facilities that collect and process donated blood.
Tobacco Products
Since the Family Smoking Prevention and Tobacco Control Act of 2009, the FDA has had broad authority over the manufacturing, distribution, and marketing of tobacco products. This includes cigarettes, smokeless tobacco, cigars, e-cigarettes, and other nicotine delivery systems. The agency reviews new tobacco products before they can be sold, sets rules for health warnings, and restricts marketing practices aimed at young people.
Cosmetics
For decades, cosmetics were one of the most lightly regulated categories under FDA oversight. That changed significantly with the Modernization of Cosmetics Regulation Act (MoCRA) in 2022, which gave the FDA several new powers. The agency can now order mandatory recalls if a cosmetic poses a serious health risk and the company refuses to pull it voluntarily. It can also access safety records related to cosmetic products and suspend a facility’s registration if products made there are likely to cause serious harm.
Before MoCRA, the FDA had no mandatory recall authority for cosmetics and limited access to company safety data. Cosmetics still don’t require pre-market approval the way drugs do, but the regulatory floor is now considerably higher than it used to be.
Radiation-Emitting Products
This category surprises most people. The FDA regulates electronic products that emit radiation, and the list extends well beyond medical equipment like X-ray machines and CT scanners. It includes microwave ovens, tanning beds, laser pointers, cell phones, fluorescent lamps, TV monitors, laser printers, and even ultrasonic toothbrushes. The FDA sets performance standards for these products to limit unnecessary radiation exposure rather than approving each one individually.
Animal and Veterinary Products
The FDA’s Center for Veterinary Medicine oversees drugs given to animals, animal feed and feed additives, and veterinary devices. This applies to pets, livestock, and other animals. For animal drugs, the approval process is conceptually similar to human drugs: manufacturers must demonstrate safety and effectiveness. The FDA shares some jurisdictional space with the USDA here, particularly for animal vaccines and other biological products, and the two agencies have formal agreements to sort out which products fall where.
What the FDA Does Not Regulate
Knowing the boundaries is just as useful as knowing the jurisdiction. The FDA does not regulate meat or poultry (that’s the USDA), most advertising claims (that’s the FTC, with the exception of prescription drug ads), alcohol (that’s the Alcohol and Tobacco Tax and Trade Bureau), drinking water from your tap (that’s the EPA, though the FDA handles bottled water), or illegal drugs and controlled substance scheduling (that’s the DEA, though the FDA is involved in approving medications that happen to be controlled substances).
The line between the FDA and FTC is worth understanding if you’ve ever wondered who polices misleading health claims. A formal agreement between the two agencies gives the FTC primary responsibility for truth in advertising of foods, non-prescription drugs, devices, and cosmetics. The FDA takes the lead on labeling for those same products and on all advertising for prescription drugs specifically.