What "FDA-Approved" Really Means

By Jane Farrell

Maybe you saw “FDA-Approved” on a company’s website or in a commercial promoting a product or treatment. Some marketers may say their products are “FDA approved.” But how can you know for sure what the U.S. Food and Drug Administration has approved?

The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.

But not all those products undergo premarket approval — that is, a review of safety, quality, and effectiveness by FDA experts and agency approval before a product can be sold to consumers. In some cases, the FDA’s enforcement efforts focus on products after they are already for sale. That is determined by Congress in establishing the FDA’s authorities. Even when FDA approval is not required before a product is sold, the agency has legal regulatory authority to act when safety issues arise.

Here is a guide to how the FDA regulates products for people — and what the agency does (and doesn’t) approve.

The FDA doesn’t approve facilities.

The FDA does not “approve” health care providers, including physician offices, or laboratories. The FDA does have authority to inspect regulated facilities to verify that they comply with current good manufacturing practices.

Although manufacturing facilities and contract manufacturers are often inspected as part of a product application for certain products that require premarket approval, the agency does not approve manufacturing facilities independently. The FDA does have authority to inspect regulated facilities to verify that they comply with applicable current good manufacturing practices and other requirements, including an adequately designed and controlled production process.

Unless an exemption applies, owners and operators of domestic or foreign food, drug, and most device facilities must register with the FDA before exporting products to the U.S. Owners and operators of establishments that manufacture blood products or cells, tissues, and cellular and tissue-based products must also register with the agency.

Mammography facilities must be FDA-certified and must display their FDA certificates where patients can see them. The certificate indicates that the facilities have met stringent standards for providing quality mammography.

The FDA does not have regulations specific to good manufacturing practices for cosmetics. Cosmetic companies are not required to register their products or facilities with the FDA but may do so voluntarily.

The FDA approves new human drugs and biological products.

New drugs and biological products for people must be FDA approved before they are marketed in interstate commerce. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards. If the FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.

Some examples of biological products that require approval are therapeutic proteins, vaccines, allergenic products, cellular and gene therapies, and products manufactured from plasma. Manufacturers must also prove that they are able to make the drug or biological product according to federal quality standards.

The FDA does not develop products before approving them. Instead, FDA experts conduct a careful evaluation of the results of laboratory, animal, and human clinical testing done by manufacturers. The FDA does perform lot release testing of many biological products, which provides the agency with a real-time system to continuously monitor product quality, through review and testing.

For more information, see:

A directory of approved and unapproved finished drugs on the market.

A complete list of licensed biological products.

The FDA doesn’t approve compounded drugs.

Compounding is generally a practice in which a pharmacist or a doctor combines ingredients to create medications that meet the needs of individual patients, including those who are allergic to ingredients in FDA-approved medicines or who cannot swallow an FDA-approved pill.

Be aware that compounded drugs are not FDA approved.

This means that the FDA does not conduct premarket review for compounded drugs to evaluate their safety, effectiveness, or quality.

The FDA uses a risk-based, tiered approach for regulating medical devices for people.

The FDA classifies devices according to risk and the level of regulatory controls needed to provide a reasonable assurance of the safety and effectiveness of the devices. The highest-risk devices (Class III), such as mechanical heart valves and implantable infusion pumps, generally require FDA approval of a premarket approval application before marketing. To receive FDA approval for these devices, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.

Generally, the FDA “clears” moderate-risk medical devices (Class II) (for example dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval. Class II devices are generally subject to special controls, which may include specific testing or labeling requirements for that device.

Devices that are low risk of harm to the user (Class I) (for example non-powered breast pumps, elastic bandages, tongue depressors, and exam gloves) are subject to general controls only, and most are exempt from premarket notification requirements.

The FDA uses a risk-based approach for human cells and tissues.

All human cells and tissues intended for use in people — collectively referred to as human cells, tissues, and cellular and tissue-based products (HCT/Ps) — are regulated to prevent the transmission of infectious disease. Examples of HCT/Ps include bone, skin, corneas, ligaments, tendons, dura mater, heart valves, and reproductive tissue.

Those HCT/Ps that pose an additional risk because of their processing or use also require FDA approval before marketing.

The FDA does not regulate the transplantation of vascularized human organ transplants such as kidney, liver, heart, lung, or pancreas. The Health Resources Services Administration (HRSA) oversees the transplantation of vascularized human organs.

The FDA doesn’t approve tobacco products.

There’s no such thing as a safe tobacco product, so the FDA’s safe and effective standard for evaluating medical products does not apply to tobacco products. Instead, the FDA regulates tobacco products based on a public health standard that considers the product’s risks to the population, including users and nonusers of tobacco products.

To legally sell or distribute a new tobacco product in the U.S., manufacturers must receive authorization from the FDA. There are three pathways available to bring a new tobacco product to market: premarket tobacco product applications, substantial equivalence applications, or exemption from substantial equivalence requests.

A marketing authorization does not indicate that the tobacco product is either safe or “approved.” It means that the manufacturer has complied with the requirements under the law to bring its product to market.

The FDA approves food additives in food for people.

Although the FDA does not have premarket approval of food products, it has the authority to approve certain ingredients before they are used in food or intended to contact food. Those include food additives (substances added intentionally to food, as well as substances that migrate to food from food contact products such as food packaging), and color additives.

Companies that want to add new food additives to food are responsible for providing the FDA with information demonstrating that the additives are safe. FDA experts review the results of appropriate tests done by companies to ensure that the food additive is safe for its intended use. An approved food additive must be used in compliance with its approved uses, specifications, and restrictions.

Certain food ingredients, such as those that are considered “generally recognized as safe” (GRAS) for their intended conditions of use by scientific experts, do not require premarket approval by the FDA. The FDA has a voluntary notification process under which a manufacturer may submit a conclusion that the use of an ingredient is GRAS.

The FDA approves color additives used in FDA-regulated products.

This includes those used in food (including animal food), dietary supplements, drugs, cosmetics, and some medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the agency before market entry, and each must be used only in compliance with its approved uses, specifications, and restrictions.

In the approval process, the FDA evaluates safety data to ensure that a color additive is safe for its intended purposes.

The FDA does not approve cosmetics.

Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. Cosmetic products and ingredients, and their labeling, do not require FDA approval.

There’s one exception: color additives (other than coal-tar hair dyes). Cosmetics must be safe for their intended use and properly labeled.

The FDA doesn’t approve medical foods.

A medical food is formulated to be consumed or administered enterally and intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. An example of a disease or condition that a medical food could be used to manage is phenylketonuria, a genetic disorder. Someone with this disorder may need medical foods that are formulated to be free of the amino acid phenylalanine.

A medical food is intended for use under the supervision of a physician. It doesn’t include products such as meal replacements or diet shakes, or products for the management of diseases, such as diabetes, that can be managed through modification of the normal diet alone.

Medical foods do not undergo premarket approval by the FDA. Still, medical food companies must comply with other requirements, such as current good manufacturing practices and registration of food facilities. Medical foods do not have to include a Nutrition Facts label on their labels; however, any statements on their label or in other labeling must be truthful and not misleading.

The FDA doesn’t approve infant formula.

The FDA does not approve infant formulas before they can be marketed. But manufacturers of infant formula are subject to the FDA’s regulatory oversight. Manufacturers must ensure that their infant formula complies with federal nutrient requirements and other regulations. Manufacturers must register with the FDA and provide the agency with an infant formula submission before marketing a new formula.

The FDA conducts yearly inspections of all facilities that manufacture infant formula and collects and analyzes product samples. The FDA also inspects new facilities. If the FDA determines that an adulterated or misbranded infant formula presents a risk to human health, the manufacturer of the formula must conduct a recall.

The FDA doesn’t approve dietary supplements.

The FDA is not authorized to approve dietary supplements for safety and effectiveness. In fact, many dietary supplements can be marketed without even notifying the FDA.

But companies are required to submit a premarket safety notification to the FDA at least 75 days before marketing dietary supplements containing certain “new dietary ingredients” (that were not marketed in the U.S. before Oct. 15, 1994).

Dietary supplement companies must ensure their products are safe before marketing and comply with other labeling and quality requirements, such as good manufacturing practices.

The FDA inspects facilities for compliance and monitors adverse event reports. When public health concerns arise about the safety of a dietary supplement or an ingredient, the FDA has the authority to take action to protect the public.

The FDA doesn’t approve the food label, including the Nutrition Facts label.

The FDA does not approve individual food labels before food products can be marketed. But FDA regulations require specific labeling elements, including nutrition information, to appear on most foods, including dietary supplements. Also, any statements on food products must be truthful and not misleading – and must comply with any regulatory requirements for the type of statement, as applicable.

Manufacturers must provide the serving size of the food and specified information about the nutrient content of each serving on the “Nutrition Facts” label (or on the “Supplement Facts” label for dietary supplements).

The FDA doesn’t approve structure-function claims on dietary supplements and other foods. Structure-function claims describe the role of a food or food component (such as a nutrient) that is intended to affect the structure or function of the human body. One example is “calcium builds strong bones.”

Dietary supplement companies that make structure-function claims on labels or in other labeling must submit a notification to the FDA. Structure-function claims on dietary supplements carry a disclaimer stating that the claim has not been evaluated by the FDA, and that the product is not intended to diagnose, treat, cure, or prevent any disease.

The FDA does not require conventional food manufacturers to notify the FDA about their structure-function claims or to carry a disclaimer.  By law, all such claims must be truthful and not misleading.

Reprinted courtesy of FDA Health Information