What Is the FDA and What Does It Do?

Medically Reviewed by Zilpah Sheikh, MD on October 26, 2023
Written by Kim Painter
8 min read

The FDA – that’s the U.S. Food and Drug Administration – is part of the federal government. Its mission is to make sure that foods, medicines, and other products important to your health are safe and work well. It gets its power from laws passed by Congress.

 

The FDA makes and enforces rules for how certain products, including foods, medicines, and medical devices, are made and sold. It also can alert the public when products are unsafe. The agency has many ways to meet these goals. Here are some of them. 
 

FDA approval
New prescription drugs need FDA approval. Medicines sold over the counter don’t need it if the agency has already OK’d the active ingredients for over-the-counter use. That’s usually the case for common medicines sold for cold and allergy symptoms, headaches, and the like. 

Companies that want to sell a new drug must do lab, animal, and human studies before they ask for FDA approval. Then, the FDA reviews the studies. Sometimes, it asks a panel of experts to weigh in. If the FDA decides the drug is safe and effective, it helps the drugmaker write labels that spell out the best way to use it. Because the approval process can take a long time, the FDA has special power to speed things up in certain cases. 

The FDA also requires some medical devices to be approved before they hit the market. Devices need approval if they will be put inside your body, can support or sustain life, or might have big risks. Breast implants and pacemakers are in this category. Companies that make such devices have to show the FDA that the benefits outweigh any risks.

New tobacco or nicotine products, like vapes, also have to go through FDA review. The FDA never calls tobacco products safe or effective. Instead, it looks at how they might affect the overall health of users and non-users alike. 


FDA registration 
Companies that make or package many products, not just approved drugs and devices, have to register with the FDA. That means they have to send the agency regular information about their facilities, so that the FDA can schedule routine inspections, make sure they operate safely, and fine them in case of a problem.

Businesses that have to register with the FDA include those that make drugs, vaccines, medical devices, most foods, and tobacco products. Facilities that make drugs for animals must register as well. A law passed in 2022 says that cosmetic makers have to register, too.


FDA recalls
When a drug or medical device has safety problems or is sold in a way that breaks the law, the FDA can ask for a recall. A recall may mean the company removes the product from the market or warns the public and corrects the problem. The FDA says most drug and device recalls are voluntary. When needed, the FDA can directly recall faulty medical devices. It can’t directly recall drugs, but it can take legal action to force a recall if needed. 

The FDA also can request or order food recalls so you know what to do if you have a food that could be harmful already in your home. For example, you might be able to take the food back to a store for a refund. Recalled foods might contain germs that could make you sick, contain a foreign object, or lack allergy warnings. 


FDA Orange Book
This is the FDA’s official list of approved prescription drugs and generic drugs that work as well and are as safe as the original drugs. It's used by pharmacists, but anyone looking for cheaper drugs can use it, too. The official name of the book is Approved Drug Products with Therapeutic Equivalence Evaluations, but it’s known as the Orange Book because the printed version has an orange cover. 


FDA drug shortage list
The agency keeps a list, updated daily, of drugs in short supply. A local or short-lived problem might not make the list. But when the agency thinks many patients and providers might have trouble finding a drug or a good substitute for a while, it starts tracking the situation and working with drugmakers to resolve it. You can find the list on the FDA's website.


FDA warning letters 
When the FDA finds that a drug company or other business is breaking FDA rules in a serious way, it may send a warning letter. The letter spells out exactly what’s wrong – like a dirty factory or an incorrect label – and tells the company how to make things right. The letter sets a deadline for action. The agency follows up to see if the problems are corrected. If not, it might take more action.  

In addition to most foods, drugs, and medical devices, the FDA oversees products that include:

  • Infant formula. The agency does not approve these products but makes sure they contain certain nutrients. It inspects baby formula plants once a year.
  • Human cells and tissues. The FDA regulates bone, skin, tendons, heart valves, and reproductive tissue to avoid the spread of infectious disease.
  • Tobacco products. In addition to deciding which new tobacco and nicotine products can go on the market, the agency works to make sure the products are not marketed to, sold to, or used by kids and teens.
  • Animal medications. The FDA approves animal drugs if companies can show they are safe, work well, and are made the same way from batch to batch. Labels must show how to use the drug and warn people about risks.
  • Bottled water. The agency can inspect bottled water plants and make sure they follow laws for drinking water safety.
  • Color additives. The FDA can approve or ban these substances in food, drugs, dietary supplements, cosmetics, and some devices.
  • Products that give off radiation. The FDA oversees devices that emit radiation – everything from microwaves to X-ray machines.
     

 

Some foods, drugs, and related products don’t fall under the FDA’s umbrella or are treated differently for one reason or another. These include:

  • Dietary supplements. The FDA has some limited power to regulate supplements, such as vitamins, minerals, and herbal products, but doesn’t review or approve them before they go on the market. Supplement makers can get into trouble if they mislabel products or include harmful ingredients.
  • Meat, poultry, and processed eggs. These are regulated by the U.S. Department of Agriculture.
  • Compounded medicines. These are custom medicines mixed by doctors and pharmacists. They are not approved by the FDA, so they may not meet the same standards for safety, effectiveness, and quality.
  • Medical foods. If you need a food to manage a disease or condition – a medical food made just for that purpose – the FDA does not treat it like other food products. For example, it does not approve new products or require them to have a Nutrition Facts label. But the labels have to be truthful.
  • Human organ transplants. Another federal agency, the Health Resources Services Administration (HRSA) oversees organs such as kidneys, lungs, and hearts.
  • Vaccines for animals. Those are covered by the Agriculture Department.
     

All drugs and medical devices have some risks, whether they're approved by FDA or not. But it may be harder to find out the risks of products that have not gone through the FDA approval process. 

The FDA inspects items to make sure they're safe and they work well, but sometimes, new risks become clear once a product is rolled out to the masses. That's where FDA tools such as recalls and warning letters come in. You and your doctor can help the FDA spot problems by reporting unexpected side effects and injuries to the agency.

When the FDA approves a drug, it’s for the treatment of specific health conditions. And it warns that using the drug any other way has not been proved safe or effective. Despite those cautions, it allows "off-label" uses. That means doctors can legally use their judgment to prescribe approved medicines to you for other reasons.

For example, if your doctor gives you a diabetes medication to help you lose weight and you don’t have diabetes, that's considered off-label use. Your doctor may know that the drug has helped many other people lose weight, and believes that it's safe for you to take. Another example: beta-blockers. These medications are FDA-approved for high blood pressure, but doctors sometimes prescribe them for anxiety.

Off-label uses don't always stay off-label. For example, in the past, beta-blockers were often prescribed off-label for heart failure, but now, with more studies completed, several are approved for that use. 

Off-label prescribing is especially common if you have a rare health issue and no other options. It’s also common with cancer, according to the American Cancer Society. Chemotherapy drugs approved for one type of cancer may target many different types of tumors. Also, cancer drugs are often combined. Doctors change their thinking on which combinations work best as they get new information. So, they may consider off-label drug use as a part of good, routine care. 


 

 

 

The FDA can speed new products to the market under its “emergency use authorization,” or EUA. In an emergency, the agency can OK unapproved medical products if another option doesn’t exist – as long as the known benefits outweigh the risks. EUA approval is only good during an approved public health emergency. That was the case with early COVID-19 vaccines. 

An EUA differs from the FDA’s “fast track.” That’s when the FDA can speed up review of a drug when a condition has no current therapies.

There’s also something the FDA manages called “compassionate use.” If someone has a life-threatening condition and no other treatment options, the agency can sometimes let them use a drug or medical device – even though it hasn't gone through the usual tests.