How Does the Food and Drug Administration Regulate Personal Care Products?

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How Does the Food and Drug Administration Regulate Personal Care Products?

A bunch of food on a table

Are Shampoos, Makeup, Skin Creams, Toothpaste, and Deodorant Approved for Safety by FDA?

Most of us take for granted that the personal grooming products we buy have been evaluated for safety. This would seem to be the responsibility of the Food and Drug Administration (FDA), which administers “The Federal Food, Drug, and Cosmetic Act.”

The truth is: it depends. According to “FDA Basics,” only some of the products commonly called “personal care products” fall into the category of cosmetics. Cosmetics include lip, eye, and face makeup, as well as skin moisturizers, nail polish, perfumes, many hair products, some toothpastes, and deodorants. Products marketed with a therapeutic claim, such as dandruff shampoo, acne cream, antiperspirants, and anti-cavity toothpastes are regulated as drugs. Some hair removal and microdermabrasion devices may be considered “medical devices” for regulatory purposes. Other related categories of products include consumer products, such as razors and manicure tools. How do these categories determine the regulatory scrutiny that a product receives?

Cosmetics

With the exception of color additives, cosmetic products and ingredients do not require FDA approval before they can be sold. The cosmetic firms themselves are responsible for establishing the safety of their products before marketing. Alternatively, a product can be labeled, “Warning–The safety of this product has not been determined.” Failure to comply is considered “misbranding,” which is a violation.

Certain ingredients, such as mercury and chloroform, are prohibited or restricted. FDA can pursue legal enforcement action against firms or individuals for products which are found to be misbranded or adulterated. Recalls of cosmetic products are voluntary actions on the part of manufacturers or distributers. FDA can monitor recalls or request them in writing, but does not have the authority to require a recall of cosmetics.

Drugs

Personal care products which fall into the category of drugs for regulatory purposes include:

— therapeutic lip balms
— diaper rash creams and ointments
— therapeutic mouthwashes
— antiperspirants
— dandruff shampoos
— acne treatments
— sunscreens

Drugs are subject to premarket approval by FDA. That means the manufacturing company must submit safety and efficacy data to the Agency for evaluation. Alternatively, new data would not be required for products conforming to the legal definition of “generally recognized as safe and effective.”

Some personal care products may be considered as both a cosmetic and a drug. Such products are required to comply with both sets of requirements. Examples would include shampoos formulated to clean hair as well as control dandruff, fluoride-containing toothpaste, and foundation makeup that contains sunscreen.

Medical Devices

Certain grooming devices meet FDA’s definition of a medical device, in that they are “intended to diagnose or treat a medical condition or affect the structure of function of the body.” Examples include hand-held cosmetic lasers designed to remove hair, stimulate hair growth, treat acne, or heal wounds. As is the case for drugs, manufacturers of medical devices are required by law to obtain marketing clearance from the FDA before the device can be sold.

Consumer Products

While items such as fake nails and false eyelashes are regulated by the FDA as cosmetics, items considered “Consumer Products” are not regulated by FDA at all. Non-medical tools and devices that people use for personal care and grooming fall under the remit of the Consumer Product Safety Commission. Consumer products include manicure tools, hair dryers, cotton swabs, razors, and electric shavers.

Safety evaluation of personal care products is a patchwork of definitions, regulations, and responsibilities, but there is an underlying thread of logic. Products and devices intended to actually alter or treat the body are given more attention than products of purely cosmetic intention.

Sources:

U.S. Food and Drug Administration, FDA Basics, “Are All Personal Care Products Regulated as Cosmetics?”

U.S. Food and Drug Administration, Cosmetics, “FDA Authority Over Cosmetics.”

U.S. Food and Drug Administration, FDA Basics, “Cosmetics Q & A: ‘Personal Care Products.'”

U.S. Food and Drug Administration, Cosmetics, “Warning Letters Highlight Differences Between Cosmetics and Medical Devices.”

U.S. Consumer Product Safety Commission.

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