NUTRITION&FOOD Published January13, 2015 By Staff Reporter

What the U.S. FDA Does Not Approve

(Photo : Tim Boyle | Getty Images News)

What does the U.S. Food and Drug Administration (FDA) not approve?Find out in the succeeding fact sheet shared by the FDA:

FDA does not approve companies.

FDA does not "approve" health care facilities, laboratories, or manufacturers. FDA does inspect product manufacturers to verify that they comply with good manufacturing practices.

Owners and operators of domestic or foreign food, drug, and most device facilities are required to register with FDA. Blood and tissue facilities also must register with the agency.

Mammography facilities must be FDA certified. Mammography facilities are required to display their FDA certificates where patients can see them. The certificate indicates that the facilities have met stringent standards and can provide quality mammography.

FDA does not approve infant formula.

FDA does not approve infant formulas before they can be marketed. However, manufacturers of infant formula are subject to FDA's regulatory oversight.

Manufacturers must ensure that infant formula complies with federal nutrient requirements. Manufacturers are required to register with FDA and provide the agency with a notification before marketing a new formula.

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 do not require FDA approval before they go on the market, with one exception: color additives (other than coal tar hair dyes.) Cosmetics must be safe for their intended use and properly labeled.

FDA field investigators inspect cosmetic companies, examine imports, and collect samples for analysis. FDA may take action against non-compliant products, or against firms or individuals who violate the law.

FDA does not approve dietary supplements.

Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety and effectiveness. Most dietary supplements that contain a new dietary ingredient (a dietary ingredient not marketed in the United States before October 15, 1994) require a notification to FDA 75 days before marketing.

The notification must include the information that was the manufacturer or distributor's basis for concluding that the dietary supplement will reasonably be expected to be safe. After dietary supplements are on the market, FDA evaluates their safety through research and adverse event monitoring.

 

From FDA.gov

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