Many products advertised online and on TV claim to be "FDA approved." But in many cases, that claim is not true.
The U.S. Food and Drug Administration is reminding Americans that not every product it regulates goes through the same approval process. While some medicines and medical devices must be approved before they can be sold, many other products do not.
The agency oversees a wide range of products, including prescription drugs, vaccines, medical devices, food, cosmetics, dietary supplements, tobacco products, and infant formula. But the rules are different for each category.
Drugs and vaccines must meet strict standards
New prescription drugs and biological products such as vaccines, gene therapies, and certain blood products must be approved by the FDA before they can be sold.
To win approval, manufacturers must show that a product is safe and works as intended. They also must prove they can make it consistently and meet federal quality standards.
Generic drugs and biosimilar medicines also undergo FDA review before they reach patients.
Not every medical device needs FDA approval
Medical devices are regulated based on their level of risk.
High risk devices, such as artificial heart valves, usually need FDA approval before they can be sold.
Many moderate risk devices can reach the market through a different process that shows they are similar to devices already being sold legally.
Lower risk products, such as bandages, exam gloves, and tongue depressors, generally do not need approval before they are sold.
Dietary supplements are not FDA approved
One of the biggest areas of confusion involves dietary supplements.
The FDA does not approve vitamins, herbal supplements, or other dietary supplements for safety or effectiveness before they are sold.
Instead, companies are responsible for making sure their products are safe and properly labeled. The FDA can inspect facilities and take action if safety problems arise.
Compounded drugs also are not FDA approved
Compounded drugs are custom made medications prepared for individual patients, often when an approved drug does not meet a patient's specific needs.
Although these medications can play an important role in patient care, they do not go through the FDA's approval process before being used.
Cosmetics usually do not need approval
Products such as makeup, shampoo, lotion, perfume, and face wash do not need FDA approval before they are sold.
However, companies are responsible for making sure these products are safe and properly labeled.
One important exception is color additives, which usually must be approved before they can be used.
Food is regulated differently
The FDA does not approve most food products before they appear on store shelves.
Instead, the agency approves certain food additives and color additives that are used in food. Companies must show those ingredients are safe before they can be used.
Food labels also are not approved before products are sold, but they must follow federal labeling rules and cannot mislead consumers.
Infant formula faces close oversight
Infant formula is not FDA approved, but it is heavily regulated.
Manufacturers must meet strict nutrition and safety requirements, notify the FDA before marketing a new formula, and undergo regular inspections. The agency also monitors products and can require recalls if safety problems are found.
Tobacco products are not FDA approved
The FDA authorizes certain tobacco products for sale, but that does not mean they are safe or approved.
The agency says there is no safe tobacco product. An authorization only means a product has met legal requirements for marketing under federal law.
The FDA does not approve doctors or hospitals
The FDA also does not approve doctors, medical offices, or laboratories.
Instead, it inspects certain facilities that make or handle regulated products to make sure they follow federal safety and quality standards.
Mammography centers are one exception. Those facilities must be certified by the FDA or by an FDA approved state certification program.
Watch out for misleading claims
The FDA says consumers should be cautious when companies advertise products as "FDA approved."
In many cases, the claim is inaccurate because the product was never required to go through the agency's approval process, especially for categories such as dietary supplements, cosmetics, and many food products.
Understanding the difference can help consumers make better decisions about the products they buy and use.