The FDA regulates and oversees a surprisingly broad range of products, from prescription drugs and vaccines to food additives, medical devices, tobacco products, and cosmetics. But “approval” means different things depending on the product category, and some products the FDA regulates never go through a formal approval process at all. Understanding these distinctions matters because companies sometimes blur the lines in their marketing.
Prescription Drugs
New prescription drugs are the product most people associate with FDA approval, and the process is among the most rigorous. A company must submit a New Drug Application containing extensive clinical trial data proving a drug is both safe and effective for its intended use. In 2024, the FDA approved 50 novel drugs that had never been marketed in the United States.
The standard review timeline gives the FDA a target of 10 months to make a decision after accepting the application. A priority review, reserved for drugs that offer significant improvements over existing treatments, shortens that target to 6 months. In 2024, 56% of novel drug approvals received priority review. These timelines don’t include the years of clinical trials a company completes before submitting the application in the first place, which typically add another 6 to 10 years.
Biologics: Vaccines, Gene Therapies, and Blood Products
Biologics are a distinct category from conventional drugs, though the line between them can be blurry. Legally, all biologics are also drugs, but they’re derived from living sources rather than synthesized chemically. This category includes vaccines, gene and cell therapies (including stem cell treatments), blood and blood components, allergenic extracts used in allergy testing and treatment, and products derived from human tissue.
Instead of a New Drug Application, biologics go through a Biologics License Application. The standard is the same: the manufacturer must demonstrate safety and effectiveness. The FDA’s Center for Biologics Evaluation and Research handles most of these reviews, including oversight of the entire blood supply and xenotransplantation products, which are tissues derived from animal sources.
Medical Devices
Medical devices follow a completely different system, and the terminology matters here. Most devices on the market are not “FDA approved.” They are “FDA cleared,” which is a lower bar.
The FDA sorts devices into three classes based on risk. Class I covers simple items like bandages and tongue depressors, which need only basic manufacturing controls. Class II includes moderately complex products like powered wheelchairs or pregnancy tests. These typically reach the market through a process called 510(k) clearance, where the manufacturer demonstrates the device is “substantially equivalent” to one already legally sold. That’s clearance, not approval.
Only Class III devices, those that sustain human life, prevent serious health impairment, or carry significant risk, require full Premarket Approval. This is the most stringent device pathway and demands valid scientific evidence of safety and effectiveness, similar in rigor to a drug application. Examples include implantable pacemakers, replacement heart valves, and certain implants. When a novel device doesn’t fit neatly into existing categories, a separate pathway called De Novo classification lets the FDA evaluate it as a Class I or Class II product.
Food and Food Additives
The FDA does not approve whole foods like fruits, vegetables, or cuts of meat. It does, however, regulate food safety and has authority over substances intentionally added to food. Any new food additive is subject to premarket review and approval before it can be used.
The major exception is substances classified as Generally Recognized as Safe, or GRAS. A substance qualifies as GRAS if qualified scientific experts agree it’s been adequately shown to be safe for its intended use. This recognition can come through published scientific evidence or, for substances used in food before 1958, through a long history of common consumption. The GRAS determination requires the same quality and quantity of scientific evidence that would be needed for formal food additive approval. Companies can self-determine GRAS status or voluntarily notify the FDA, but formal FDA approval of the substance itself isn’t required.
Dietary Supplements
This is one of the most commonly misunderstood areas of FDA regulation. The FDA does not approve dietary supplements before they go on sale. Under the Dietary Supplement Health and Education Act of 1994, manufacturers are responsible for evaluating the safety and labeling of their own products before marketing them. The FDA can only take action against a supplement after it reaches the market, and only if the product is found to be adulterated or mislabeled.
This means that when you see a vitamin, herbal extract, or protein powder on store shelves, no government agency has reviewed it for safety or verified that it contains what the label claims. If a supplement label says “FDA approved,” that claim is false.
Tobacco Products
Since 2009, the FDA has regulated tobacco, and the agency uses the term “authorized” rather than “approved” for these products. Any new tobacco product, including e-cigarettes and vaping devices, must submit a Premarket Tobacco Product Application before it can legally be sold. The application must include full reports on health risks, a complete list of components and ingredients, manufacturing methods, proposed labeling, and critically, evidence about the product’s effect on the population as a whole, including people who don’t currently use tobacco.
The FDA grants a marketing order only if it determines that permitting the product would be “appropriate for the protection of public health.” This is a different standard than drugs or devices. The agency isn’t evaluating whether the product is safe and effective. It’s weighing whether allowing the product on the market, considering both users and nonusers, serves public health overall.
Cosmetics
Cosmetics historically received minimal FDA oversight, but that changed with the Modernization of Cosmetics Regulation Act (MoCRA) signed in 2022. The FDA still does not approve cosmetics before sale, but manufacturers and processors must now register their facilities with the agency and renew that registration every two years. They must also list each marketed product and its ingredients, with annual updates.
The FDA gained real enforcement teeth under MoCRA: it can suspend a facility’s registration if a product has a reasonable probability of causing serious harm or death, and a suspended facility cannot distribute or sell any cosmetic products in the United States. Before this law, the FDA had very limited tools to act against unsafe cosmetics.
Emergency Use Authorizations
During public health emergencies, the FDA can issue an Emergency Use Authorization that allows unapproved products, or unapproved uses of approved products, to be used for diagnosing, treating, or preventing serious or life-threatening conditions. An EUA is not approval. The legal threshold is lower: the FDA must determine that the known and potential benefits outweigh the known and potential risks, and that no adequate approved alternatives exist.
EUAs became widely known during the COVID-19 pandemic when vaccines were initially authorized through this pathway before receiving full approval. The FDA expects manufacturers who receive an EUA to continue clinical trials and pursue standard licensure.
What “FDA Approved” Actually Means on a Label
The FDA logo and name are federal trademarks reserved exclusively for official government use. Private companies cannot use the FDA logo on their packaging, websites, or marketing materials unless specifically authorized in writing. Any unauthorized use, including slapping “FDA approved” on a product that hasn’t gone through the relevant process, may violate federal law and expose the company to civil or criminal liability.
If a company identifies the FDA in communications, it must use only the full legal name or the “FDA” initialism in plain text, the same size and font as surrounding words. When you see a product with the FDA logo prominently displayed or bold “FDA APPROVED” claims, particularly on supplements, cosmetics, or foods, that’s a red flag. The product either hasn’t gone through the process those words imply, or the company is misrepresenting its regulatory status.