The FDA, or Food and Drug Administration, is the U.S. federal agency responsible for protecting public health by regulating the safety of food, drugs, medical devices, cosmetics, tobacco products, and more. With a fiscal year 2024 budget of approximately $6.9 billion, it is one of the largest consumer protection agencies in the country, touching nearly every product Americans eat, apply to their skin, or use to treat an illness.
What the FDA Actually Regulates
The FDA’s reach is broader than most people realize. Beyond prescription drugs and food safety, the agency oversees dietary supplements, bottled water, infant formula, vaccines, blood products, gene therapies, surgical implants, heart pacemakers, pet foods, livestock feeds, veterinary drugs, cosmetics like nail polish and moisturizers, and even electronic products that emit radiation (think microwave ovens, X-ray machines, and laser products). It also regulates the manufacturing, marketing, and distribution of tobacco products, including cigarettes, smokeless tobacco, and e-cigarettes.
One notable gap: the U.S. Department of Agriculture, not the FDA, takes the lead on regulating meat, poultry, and certain egg products. The two agencies share responsibility for the food supply, but their jurisdictions are separate.
How the FDA Approves New Drugs
Getting a new drug to market is a multi-step process that typically takes years. It starts with preclinical research, where a drug is tested in laboratories and on animals to answer basic safety questions. If those results are promising, the drug moves into clinical research, which means testing on people in progressively larger trials to evaluate both safety and effectiveness.
Once clinical trials are complete, the company submits all its data for FDA review. Review teams examine everything from trial results to manufacturing quality before deciding whether to approve the drug. But approval isn’t the finish line. The FDA continues monitoring a drug’s safety after it reaches the market, watching for problems that may not have appeared during trials. This post-market surveillance is a critical layer of protection, since rare side effects sometimes only surface once millions of people are taking a medication.
Supplements Play by Different Rules
One of the most widely misunderstood aspects of the FDA is how it handles dietary supplements. Unlike prescription drugs, which must be proven safe and effective before they can be sold, supplements do not require FDA approval before reaching store shelves. Under a 1994 law known as DSHEA, the agency is largely limited to taking action after a product is already on the market. Manufacturers don’t generally have to share their safety evidence with the FDA before or after selling their products.
There is one exception: supplements containing a “new dietary ingredient” require the manufacturer to notify the FDA at least 75 days before selling, along with evidence that the product is reasonably expected to be safe. And any supplement that claims to treat, prevent, or cure a specific disease crosses the line into drug territory and becomes subject to drug regulations. But the practical reality is that the supplement aisle operates under far less oversight than the pharmacy counter.
How the FDA Monitors Safety After Approval
The FDA runs a reporting program called MedWatch that collects safety reports from health professionals, patients, and consumers. If you experience a bad reaction to a prescription drug, an over-the-counter medication, a medical device, a cosmetic, or even a CBD product, you can file a report through MedWatch. When the agency identifies a pattern or a serious risk, it publishes safety alerts and can require label changes, restrict a product’s use, or pull it from the market entirely.
Product recalls fall into three classes based on how dangerous the problem is. A Class I recall means there’s a reasonable chance the product could cause serious harm or death. A Class II recall involves products that might cause temporary or reversible health problems, or where the risk of something serious is remote. A Class III recall covers situations where the product is unlikely to cause any health consequences at all, such as a minor labeling error.
Where the Money Comes From
The FDA’s $6.9 billion budget is split almost evenly between two sources. About 52% ($3.6 billion) comes from federal budget authorization, meaning taxpayer dollars. The remaining 48% ($3.3 billion) comes from industry user fees. These fees are paid by companies that submit drugs, medical devices, and other products for FDA review. The user fee system speeds up review timelines by giving the agency dedicated funding for evaluation staff, but it also draws occasional criticism from those who see a potential conflict in an agency being partially funded by the industries it regulates.
How the FDA Came to Exist
The FDA traces its roots to 1906, when President Theodore Roosevelt signed the Food and Drugs Act. The law came after decades of failed attempts (nearly 100 bills had been introduced in Congress since 1879) and a wave of investigative journalism that exposed dangerous conditions in the food and drug marketplace. Upton Sinclair’s novel “The Jungle,” which revealed the horrifying state of the meatpacking industry, was the final push that led to both a meat inspection law and the broader food and drug legislation.
That original law was relatively modest by today’s standards. It prohibited shipping adulterated or mislabeled food and drugs across state lines, required that dangerous ingredients like alcohol, heroin, and cocaine be listed on labels, and banned misleading labeling. But it relied on regulating labels rather than requiring pre-market approval. The system of testing and approving products before they reach consumers developed through later legislation over the following decades, gradually building the FDA into the agency it is today. The current commissioner, Martin Makary, was sworn in as the 27th head of the agency in April 2025.