Labeling Laws for Personal Care Products: Potential Pitfalls for the Consumer

Evelyne Tantry; Ariadna Perez-Sanchez, MD; Shelly Fu; Shravya Potula; Rajani Katta, MD


Skin Therapy Letter. 2021;26(5):1-6. 

In This Article


For consumers choosing among the wide variety of personal care products available, an understanding of current labeling laws and regulations is important. Consumers may be interested in choosing products for sensitive skin, searching for products that are suitable for children, or seeking out products that lack specific allergens. Unfortunately, current regulations limit the utility of many labeling terms to effectively inform the consumer, making it imperative that physicians counsel patients on the specifics of these terms. In this paper, we review areas where consumers may find labels confusing. For each area, we highlight potential pitfalls for consumers when choosing personal care products.

"Personal care products" are not defined by law but rather serve as a general category that can consist of cosmetics, drugs, medical devices, dietary supplements and consumer goods based on the nature of intended use.[1] Use of such products may result in allergic contact dermatitis (ACD). Data from the North American Contact Dermatitis Group (NACDG), published in 2018, found that of the top 10 allergens identified by patch testing, nine could be found in personal care products.[2] This included six fragrance additives and preservatives, two topical antibiotics (neomycin and bacitracin), and one chemical found in hair dyes (p-phenylenediamine). The treatment of ACD centers on allergen avoidance, and thus an understanding of labeling laws and regulations is critical.

As consumers are faced with a multitude of personal care products, physicians can help by educating them on pertinent regulations and labeling laws. It is important consumers recognize that marketing and safety of personal care products is the responsibility of the manufacturer and is not subject to premarket approval from the US Food and Drug Administration (FDA).[3] "Cosmetics", as defined by the FDA, are any articles intended to be applied to the human body for appearance-altering purposes and include moisturizers, shampoos and makeup.[3] 'Soaps' fall into a separate category when they are mainly composed of "alkali salts of fatty acids,"[4] although the product becomes a "cosmetic" if it contains synthetic detergents or is intended to moisturize or deodorize the body.[4]

The FDA primarily governs cosmetics and other personal care products through the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) and the Fair Packaging and Labeling Act of 1967 (FPLA).[3] With these acts, Congress created broad parameters to enable effective regulation of a burgeoning industry. Since their establishment, however, these mandates have not undergone any substantial reform to accommodate the explosive growth of available personal care products.

Table 1 outlines several pertinent regulatory policies that consumers should be made cognizant of when evaluating personal care products. It is vital that consumers recognize that current labeling laws permit the use of language that may be applied solely for marketing, may be incomplete, or may be misinterpreted. Table 2 provides a brief overview of potential pitfalls for the consumer due to current labeling regulations.