Chances are, you’ve heard the term FDA -- that’s the U.S. Food and Drug Administration. What is the FDA, what do they do, and what don’t they do? And perhaps most importantly, does something that’s FDA-approved mean it’s safe?
The FDA is a federal government agency that works to make sure our foods, medicines, and other products we use are safe and effective. It's part of the Department of Health and Human Services, and the FDA also alerts the public when a product is not safe.
What Does the FDA Do?
The FDA regulates (or has control over) certain foods, medicines, and medical devices -- including the way products are made. It can also make sure that these products and manufacturers follow safety laws. In some cases, the FDA makes sure you know about the risks associated with products (like they do with cigarettes).
When the FDA regulates something, such as medicine, it requires approval before the product goes on the market. They can monitor products to make sure they’re being produced safely -- and continue to be safe and effective. The FDA can inspect facilities that produce foods and drugs and can take samples to make sure manufacturers and facilities are following the laws. In other cases, they can step in after something is being sold if it’s not being marketed accurately, like if something says it will help with a medical condition when that hasn't been proven, or if people complain about it.
One way they promote product safety is by making sure items are labeled properly -- and that manufacturers comply with labeling standards.
The FDA also manages the process to get new drugs on the market and has special power to speed up the process in certain instances (like when it got COVID-19 vaccines on the market so quickly).
Tobacco products fall under the FDA umbrella. But the agency doesn’t approve them for safety or effectiveness. Instead, they make sure that manufacturers are following the rules and warning people about the risks of those items.
What Does the FDA Regulate?
Drugs and biologics. The FDA can approve (or reject) new drugs and biological products such as medications, vaccines, and gene therapies before they go on the market. The FDA regulates over-the-counter drugs, but only after they’re for sale. They don’t approve compounded drugs -- that’s when a doctor mixes ingredients to create custom medications. FDA approval means a product is safe and effective to the best of the agency’s knowledge. But, it doesn’t mean your insurance will cover it.
Medical devices. The FDA approves items like mechanical heart valves and stents. Devices with a lower risk only have to meet baseline requirements.
Human cells and tissues. The FDA regulates bone, skin, tendons, heart valves, and reproductive tissue to avoid the spread of infectious disease. But they don’t handle human organ transplants (like kidneys and livers). That falls under the Health Resources Services Administration (HRSA).
Tobacco products. These aren’t safe or effective, but the FDA authorizes them if the manufacturer meets their rules for alerting the public to safety risks before it goes on the market. They also have oversight over products that contain nicotine but not tobacco, such as vapes. The department works to make sure the products are not marketed to, sold to, or used by youths.
Animal medications. The FDA gives the go-ahead to animal prescriptions. The drugs must be safe and work well, and the company must show the drug is made the same from batch to batch. A drug company also must have labels that show how to use the drug and warn people about its risks.
The FDA doesn’t approve devices -- like surgical instruments and syringes -- but they can take action if they’re different than advertised. Pet food and pet treats don’t need FDA approval to go on the market. The same goes with animal feed, which can include food given to animals that are later eaten.
Vaccines for animals don’t fall under FDA jurisdiction. The U.S. Department of Agriculture (USDA) handles that.
Food. The FDA doesn’t regulate poultry, livestock, and eggs – that’s the USDA’s job. They can OK food additives that are put in food or come into contact with it, though it can be a long process. Ingredients that are “generally recognized as safe,” or GRAS, don’t have to be approved. Instead, the manufacturer can voluntarily submit a statement that the additive falls into that designation.
The FDA can inspect bottled water facilities and make sure manufacturers follow laws governing drinking water safety.
Color additives. The FDA regulates these substances in food, drugs, dietary supplements, cosmetics, and some devices.
Products that give off radiation. The FDA regulates electronics that emit radiation -- everything from microwaves to X-ray machines.
What Doesn’t the FDA Regulate?
Cosmetics. While makeup, lotions, perfumes, shampoos, hair dyes, and similar products aren’t regulated by the FDA, color additives in them must be approved before going on the market. The FDA has oversight on other cosmetics after they are on sale. Ingredients must be properly labeled, and the FDA can enforce those laws if a product doesn’t comply.
Medical foods. If you need a food to manage a disease or condition -- a medical food -- the FDA doesn’t have oversight on it. The manufacturing processes must stick to certain rules, but it doesn’t need a Nutrition Facts label on it (though the labeling must be truthful).
Dietary supplements. Products like multivitamins are regulated by the FDA, but it works a little differently than how they manage medicines and medical devices. With dietary supplements, the FDA manages the finished product – it doesn’t approve them before they go on the market. The FDA can take action if a product's ingredients don’t match what’s on the label.
The FDA has faced criticism for not taking more authority over these products before they’re sold. They say they don’t have enough data about what’s actually in them. Some people say the agency doesn’t do enough to ensure supplements don’t contain fraudulent, or false, material, which can include prescription substances.
Baby formula. These don’t have to be approved before a company sells them, but the company must meet federal nutrient requirements and other rules. For instance, a formula-maker has to register with the FDA and submit the product. The FDA inspects manufacturing facilities yearly. They can collect and evaluate samples.
Is It Safe to Use Something That’s Not FDA Approved?
Not necessarily. But FDA approval doesn’t guarantee safety, either.
The FDA approves items for safety and effectiveness, but there can still be risks involved in FDA-approved products. Sometimes, a product deemed safe isn’t actually so when it’s rolled out to the masses. In those cases, the FDA can issue a recall -- and it can’t be sold anymore.
Does the FDA Manage Off-Label Drugs?
If your doctor prescribes a medicine for you on an “off-label” basis, that means the medicine is FDA-approved, but you’re not using it for its approved use. The medicine is considered safe (though not without risk). Drugs are approved for specific uses. Sometimes doctors find they are effective for other purposes that don’t fall under the approved use. The FDA will let your doctor prescribe it based on the doctor's judgment.
For example, if your doctor gives you a diabetes medication to help you lose weight and you don’t have diabetes, that is considered off-label use. (In that case, many people have found the drug helps people lose weight; the FDA just hasn’t approved it for that.)
How Does the FDA Impact Public Health?
By regulating drugs, devices, food, and other items, the FDA can protect public health. They provide a level of protection to try to prevent infectious diseases, as well as false substances and products. If a product doesn’t meet standards, the FDA issues a product recall that alerts the public not to use a product. They can also notify you about risks from a product.
What Other Power Does the FDA Have?
The FDA can speed up innovations to help people under its “emergency use authorization,” or EUA. In an emergency, the department can OK unapproved medical products if another alternative doesn’t exist -- and it has to be when the known benefits outweigh the risks. Products approved under an EUA are only approved so long as an approved public health emergency. (This is the case with COVID-19 vaccines.)
EUA differs from the FDA’s “fast track” designation. That’s when the FDA can speed up the review of a drug without a current therapy.
There’s also something the FDA manages called “compassionate use.” That’s when the FDA can approve a drug, biologic, or medical device for someone who has a life-threatening disease or condition (and there’s no alternative) -- even though the drug hasn’t gone through clinical trial requirements.