Perhaps you saw those words on a company’s website, or in a commercial promoting a new product. Some marketers may say their products are “FDA approved,” but how can you know for sure what the U.S. Food and Drug Administration approves?
The FDA is responsible for protecting public health by regulating human drugs and biologics, 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 and effectiveness by FDA experts and agency approval before a product can be marketed. Here are some examples of what the agency does (and doesn’t) approve.
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, and each must be used only in compliance with its approved uses, specifications, and restrictions. In the approval process, FDA evaluates safety data to ensure that a color additive is safe for its intended purposes.
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 agency’s regulatory oversight.
Manufacturers must ensure that infant formula complies with federal nutrient requirements. Manufacturers must register with the FDA and provide the agency with a notification before marketing a new formula. The FDA conducts yearly inspections of all facilities that manufacture infant formula and collects and analyzes product samples. The agency also inspects new facilities. If FDA officials determine that an infant formula presents a risk to human health, the manufacturer of the formula must conduct a recall.
The FDA doesn’t approve the food label, including the Nutrition Facts panel
The FDA does not approve individual food labels before food products can be marketed. But FDA regulations require nutrition information to appear on most foods, including dietary supplements. Also, any claims on food products must be truthful and not misleading, and must comply with any regulatory requirements for the type of claim.
The FDA doesn’t approve dietary supplements
Unlike new drugs, dietary supplements are not reviewed and approved by the agency based on their safety and effectiveness. When public health concerns arise about a dietary supplement after the product is on the market, the FDA evaluates the product’s safety through research and adverse event monitoring.
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 is not appropriate for tobacco products. Instead, it regulates tobacco products based on a public health standard that considers the product’s risks to the population as a whole.
To legally sell or distribute a new tobacco product in the United States, manufacturers must receive a written order from FDA. A marketing order 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 does not approve cosmetics
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 before they go on the market. There’s one exception: color additives (other than coal-tar hair dyes). Cosmetics must be safe for their intended use and properly labeled.