Is It Really 'FDA Approved'

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"FDA approved!"

Maybe you saw those words on a company's website or in an ad promoting a product or treatment. Some marketers may say their products are "FDA approved." 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 statutory authority means that the agency needs to focus on products after they are already for sale. That is determined by Congress in establishing the FDA's authorities. Here is a guide to how the FDA regulates products - and what the agency does (and doesn't) approve.

The FDA doesn't approve health care providers.

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 certain legal requirements that can affect the safety or quality of products produced or stored in those facilities.

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

Unless an exemption applies (like domestic manufacturing facilities), drug, foreign food, and most device facilities must register with the FDA before exporting products to the U.S. Mere registration of an establishment or listing of a drug or device does not denote approval of the establishment, the drug or device, or other drugs or devices of the establishment, nor does it mean that a product may be legally marketed.

Mammography facilities must be certified by the FDA, or by a state that has received FDA approval as a certifier and must display their FDA certificates where patients can see them. A mammography facility that receives Mammography Quality Standards Act (MQSA) certification has shown it is capable of providing quality mammography.

The FDA approves new human drugs and biological products.

With rare exceptions, new drugs and biological products for people must be FDA approved before they are marketed, offered for sale, or shipped in interstate commerce. This means 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 the benefits of a drug outweigh the risks for the intended use, or that a biological product is safe, pure, and potent.

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 they are able to make the drug or biological product according to federal quality standards.

The FDA also approves generic drugs and biosimilar medications for patient use. Biosimilars and generics are FDA-approved medicines that increase access to treatment options at potentially more affordable prices through increased competition with innovator medications.

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 certain biological products, which provides the agency with a real-time system to continuously monitor product quality, through review and testing.

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The FDA doesn't approve compounded drugs.

Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug 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.

Although they can be important parts of America's health care system, compounded drugs are not FDA approved. By statute, compounders do not need to prove to the FDA that their products meet the same standards that drug manufacturers need to meet. 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 medical 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, manufacturers of moderate-risk medical devices (Class II) (for example dialysis equipment and many types of catheters) may market such devices pursuant to so-called "510(k) clearance," allowing distribution once the manufacturer has demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval. Class II devices are subject to general controls and can also be subject to special controls. Special controls 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. 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 oversees the transplantation of vascularized human organs.

The FDA doesn't approve tobacco products.

There's no such thing as a safe tobacco product. By statute, 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 and benefits to the population as a whole, including users and non-users of the tobacco product.

To legally sell, market, manufacture, or distribute a new tobacco product in the U.S., an applicant 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, and exemption from substantial equivalence requests.

A marketing authorization does not indicate that the tobacco product is safe or "FDA approved," and many marketed tobacco products are not actually being legally sold. Rather, the issuance of a marketing authorization means that the applicant has complied with the requirements under the law to bring its product to market. The FDA lists all authorized tobacco products in its Searchable Tobacco Products Database.

The FDA approves food additives.

Although the FDA does not approve food products, certain ingredients must be approved by the FDA before they are used in food or in materials that contact food. Those include food additives (certain substances added intentionally to food, as well as certain substances that migrate to food from food contact products such as food packaging), and color additives, unless they are subject to an exception, such as the "generally recognized as safe" (GRAS) exception.

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 information submitted by companies, as well as other available safety data and information, to determine whether 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 GRAS by scientific experts under their conditions of intended use, 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 doesn't approve cosmetics.

Cosmetics must be safe for their intended use and properly labeled.

Examples of cosmetics include 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), which need to be approved by the FDA for their use.

The FDA generally doesn't approve medical foods.

A medical food is formulated to be consumed or administered enterally under the supervision of a physician and is 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.

Medical foods do not include products such as meal replacements or diet shakes, or products for the management of diseases 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 practice and registration of food facilities. Medical foods do not have to include a Nutrition Facts label on their labels. But any statements on their label or in other labeling must be truthful and not misleading.

The FDA doesn't approve infant formula, but infant formula is heavily regulated.

The FDA does not approve infant formulas before they can be marketed. But new infant formulas are subject to a premarket review by the FDA, and the FDA can object to product or ingredient being notified.

Manufacturers must ensure that their infant formula complies with federal nutrient and safety requirements and other regulations. Manufacturers must register all establishments at which they intend to manufacture new infant formula and provide the agency with a new infant formula submission at least 90 days before marketing a new formula. The FDA reviews the information in the submission for safety, nutritional adequacy, and to evaluate compliance with other important requirements. Both infant formulas and manufacturers of infant formula are subject to the FDA's regulatory oversight.

The FDA conducts at least yearly inspections of all facilities, including new ones, that manufacture infant formula and collects and analyzes product samples. If the FDA determines that an infant formula that has left the control of the manufacturer may not provide all required nutrients or is otherwise adulterated or misbranded, and that such formula presents a risk to human health, the manufacturer of the formula must conduct a recall. Examples of an adulterated infant formula include a formula that contains less than the minimum required amount of a nutrient, or a formula contaminated with bacteria that can make an infant sick.

The FDA doesn't approve dietary supplements.

By statute, the FDA does not approve dietary supplements for safety and effectiveness. In fact, many dietary supplements can be marketed without even notifying the FDA.

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

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 a product's food label, including its Nutrition Facts label.

The FDA does not approve individual labels before food products, including dietary supplements, 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 generally doesn't approve structure-function claims on dietary supplements and other foods.

Structure-function claims describe the role of a food, including dietary supplement, 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.

Conventional food manufacturers are not required to notify the agency about structure-function claims associated with their products or to include a disclaimer. By law, all such claims must be truthful and not misleading.

The misuse of the FDA's logo may violate federal law.

The FDA's logo is for official government use only. The FDA's logo should not be used to misrepresent the agency or to suggest that the FDA endorses any private organization, product, or service.

These are just some of the many ways the FDA is responsible for protecting the public health.