Consumer Safety Series: Are All Personal Care Products Regulated as Cosmetics?

 It is often mistakenly assumed that all personal care products are regulated as cosmetics, but this isn’t the case. The U.S. Food and Drug Administration (FDA) classification of a personal care product largely depends on its composition and intended use. Item categorization includes:

Cosmetics. Products categorized as cosmetics include moisturizer, perfume, lipstick, nail polish, makeup, shampoo, permanent waves, hair dye, toothpaste, and deodorant. With the exception of color additives, items in this group do not receive FDA premarket approval. Of course, companies that produce these goods are responsible for ensuring they’re safe for consumer use.

Drugs. Any item used to treat or prevent disease or designed to impact the structure of the body or its ability to function is considered a drug — including those affecting physical appearance. Examples of products that fall into this group include acne medication, dandruff treatments, antiperspirants, and diaper creams. Those requiring a prescription typically must receive FDA approval, while over-the-counter products are generally required adhere to category-specific monographs.

Cosmetics and Drugs. Some products can actually fall under both the cosmetic and drug categories. For example, moisturizers and makeup with SPF, anti-dandruff shampoos, and antiperspirant-deodorants are required to meet the standards for both classes.

Other Categories. Products that don’t fit into the cosmetic or drug groups may fall into a host of other classifications, including over-the-counter medications (i.e., anti-wrinkle creams), medical devices (i.e., hair removal and microdermabrasion products), dietary supplements (i.e., vitamins and minerals) and consumer products (i.e., as manicure sets).

Personal Care Product Safety

When consumers purchase a personal care item, they expect it to be properly tested and contain ingredients that are safe for use. Ensuring items are safe when used as directed is actually the responsibility of the manufacturer, as all personal care products are not subject to FDA approval.

While cosmetic items do not need the agency’s approval to enter the market, the FDA’s Center for Food Safety and Applied Nutrition does approve the color additives used in these items and regulates products to ensure they’re safe and labeled properly.

Check back soon for the second installment of our four-part consumer safety series, “How to Distinguish Between Cosmetics and Medical Devices.”

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