The FDA regulates a surprisingly broad range of products, from prescription drugs and medical devices to pet food and microwave ovens. But not everything under FDA oversight actually needs “approval” before it can be sold. Some products require full premarket approval, others need a less rigorous clearance or notification, and some can go to market with no FDA review at all as long as they meet certain standards.
Understanding the difference matters whether you’re a consumer trying to gauge how thoroughly a product was vetted, or a business figuring out what regulatory path applies to your product.
Prescription and Over-the-Counter Drugs
Every new drug sold in the United States, whether prescription or over-the-counter, needs FDA approval before it reaches patients. A company must submit a New Drug Application that demonstrates the drug is both safe and effective for its intended use, and that it can be manufactured consistently with proper quality controls and accurate labeling. This process typically involves years of clinical trials in humans.
Generic drugs follow a shorter path. Instead of repeating all the original clinical trials, a generic manufacturer submits an Abbreviated New Drug Application showing that its version is bioequivalent to the already-approved brand-name drug. It still needs FDA approval, but the process is faster and less expensive because the safety and effectiveness data from the original drug carries over.
Medical Devices
Medical devices are sorted into three classes based on the risk they pose to patients, and the regulatory requirements scale accordingly.
- Class I (lowest risk): Simple items like tongue depressors, bandages, and bedpans. Most are exempt from any premarket submission and just need to follow basic manufacturing standards.
- Class II (moderate risk): Products like powered wheelchairs, pregnancy tests, and some surgical instruments. These typically require a 510(k) clearance, which is not the same as approval. The manufacturer must show the device is “substantially equivalent” to one already legally on the market. No clinical trials are usually needed.
- Class III (highest risk): Complex, life-sustaining products like heart pacemakers, implantable defibrillators, and replacement heart valves. These require a full Premarket Approval Application with clinical data proving safety and effectiveness, similar in rigor to what drugs go through. The FDA user fee alone for a PMA application is over $540,000 as of fiscal year 2025.
The distinction between “clearance” (510k) and “approval” (PMA) is important. When a company says its device is “FDA cleared,” that means the FDA agreed it’s similar enough to an existing product. “FDA approved” means the agency independently reviewed clinical evidence that the device works and is safe.
Vaccines, Blood Products, and Gene Therapies
Biological products occupy their own regulatory category. Vaccines, blood and blood products, cellular and gene therapies, tissue-based products, and allergenics all require a Biologics License Application before they can be marketed. This is a rigorous approval process that evaluates safety, effectiveness (called “purity and potency” for biologics), and manufacturing consistency. Because biologics are made from living organisms or their components, the manufacturing process itself is scrutinized more heavily than for conventional drugs.
Food Ingredients and Additives
Whole foods like fruits, vegetables, and grains do not need FDA approval before they’re sold. But any substance intentionally added to food is considered a food additive and requires premarket approval, with one major exception: ingredients that are “Generally Recognized as Safe,” or GRAS.
A substance qualifies as GRAS either through published scientific evidence or through a long history of safe use in food before 1958. Common examples include vinegar, baking soda, and many spices. The GRAS standard requires the same quality and quantity of scientific evidence as formal food additive approval would. The difference is that qualified experts have already reached consensus on safety, so no FDA petition is needed. Companies can voluntarily notify the FDA about a GRAS determination, but they’re not required to.
Color additives are a notable exception to the GRAS shortcut. Every color additive used in food, drugs, cosmetics, or medical devices must be pre-approved by FDA and listed in the color additive regulations before use. The only exception is coal tar hair dyes.
Dietary Supplements
Dietary supplements, including vitamins, minerals, herbs, and amino acids, do not need FDA approval for safety or effectiveness before they hit store shelves. The manufacturer is responsible for ensuring its product is safe, but the FDA does not verify those claims before the product is sold.
There is one requirement: if a supplement contains a “new dietary ingredient,” one that wasn’t marketed before October 1994, the manufacturer must notify the FDA at least 75 days before selling it. The notification must include information supporting the conclusion that the ingredient is reasonably expected to be safe. But this is a notification, not an approval. The FDA can object, but the product can still go to market unless the agency takes enforcement action.
Cosmetics
Cosmetics and personal care products like moisturizers, nail polish, perfume, and makeup do not require FDA approval before sale. The manufacturer is responsible for product safety. The FDA can take action against a cosmetic that’s found to be unsafe or mislabeled, but there’s no premarket review process.
The exception, again, is color additives. Any pigment or dye used in cosmetics must be FDA-approved and listed in the regulations before a company can use it. This applies to everything from lipstick shades to the dyes in shampoo.
Tobacco and E-Cigarettes
Any tobacco product that wasn’t commercially marketed as of February 15, 2007, is considered a “new tobacco product” and needs FDA authorization before it can be sold. This includes most e-cigarettes, vape products, and newer flavored tobacco items.
The pathway is called a Premarket Tobacco Product Application. Unlike drugs, the standard isn’t “safe and effective.” Instead, the manufacturer must demonstrate that marketing the product is “appropriate for the protection of public health.” The FDA weighs the risks and benefits to the entire population, considering whether the product would help current smokers quit while also considering whether it might attract people who don’t currently use tobacco. The FDA finalized rules for this process in 2021, and thousands of e-cigarette products have since been denied authorization.
Veterinary Drugs and Animal Feed
Drugs intended for animals follow a parallel approval system. A New Animal Drug Application must demonstrate that the drug is safe and effective for the intended animal species. This covers everything from antibiotics for livestock to flea medications for pets.
There’s also a conditional approval pathway that allows a product to be marketed for up to five years while the manufacturer continues collecting effectiveness data. Under conditional approval, the drug has met all requirements except the full standard for effectiveness. Instead, the manufacturer needs to show a “reasonable expectation” that the drug works. This pathway helps get needed treatments to animals faster, particularly for rare conditions where large-scale studies are harder to conduct.
Radiation-Emitting Electronics
Products that emit radiation, including microwave ovens, X-ray machines, laser products, ultrasonic therapy devices, and sunlamps, don’t go through a traditional approval process. Instead, manufacturers must comply with specific performance standards set by the FDA and submit product reports before marketing. They’re also required to keep detailed test and distribution records, and to report any accidental radiation incidents. The requirements vary by product type and risk level. A high-powered surgical laser, for example, faces more extensive reporting and record-keeping obligations than a standard microwave oven.
Quick Comparison: Approval vs. No Approval
- Full FDA approval required: Prescription drugs, over-the-counter drugs, generic drugs, vaccines, blood products, gene therapies, Class III medical devices, new food additives, color additives, new tobacco products, veterinary drugs
- FDA clearance or notification (not full approval): Class II medical devices (510k clearance), new dietary ingredients (notification only), radiation-emitting products (product reports and standards compliance)
- No premarket FDA review: Most cosmetics, dietary supplements with pre-1994 ingredients, whole foods, GRAS food ingredients, Class I exempt medical devices
The level of FDA scrutiny a product receives before sale varies enormously. A new cancer drug goes through a decade of clinical testing. A new moisturizer can be on shelves tomorrow. Both fall under FDA jurisdiction, but the word “regulated” means very different things depending on the product category.