The FDCA and Cosmetics Enforcement: Better Late than Never

Sei Unno

Associate Editor

Loyola University Chicago, JD 2019

In March 2019, the FDA issued a statement explaining that asbestos was found in certain cosmetic products sold at retail stores Claire’s and Justice. The Food, Drug, and Cosmetics Act (FDCA) has always granted the FDA similar authority to monitor cosmetic products for adulteration or misbranding as it does food. However, litigation in this area was notably silent. The FDA’s change in position on its authority is long overdue.

Overview of FDCA and Cosmetics

The FDCA contains provisions for adulteration and misbranding of cosmetics. Cosmetics are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body . . . for cleaning, beautifying, promoting attractiveness, or altering the appearance.” Adulteration includes things such as containing “poisonous or deleterious substance[s],” contains “any filthy, putrid or decomposed substance,” “has been prepared, packed, or held under insanitary [sic] conditions,” among other provisions. A cosmetic is considered to be misbranded if its container or labeling is misleading, the label does not state the name and place of business of the manufacturer, packer, or distributer, an inaccurate statement of the contents in terms of weight, measure, or numerical count, along with other considerations.

Although the FDA does not require cosmetic products and ingredients to obtain pre-market FDA approval, cosmetics are regulated after they are introduced into interstate commerce. Interstate commerce is defined as “commerce between any State or Territory and any place outside thereof, and commerce within the District of Columbia or within any Territory not organized with a legislative body.” In 2018, online sales of cosmetics increased by 24% in the United States. This rate is greater than the overall United States e-commerce growth rate. Not only have domestic e-commerce retailers like Glossier expanded, Japanese skincare and cosmetics retailer Kosé Corporation’s online sales grew by 85% in 2018.Asian skincare in general has experienced an increase in sales in the United States.

The FDA works with U.S. Customs and Border Protection to monitor imported cosmetics. Imported cosmetics are subject to review by the FDA at the time of entry into the United States and products that do not comply are subject to refusal of admission. Although the FDA does not inspect every shipment of cosmetics into the United States, they are still subject to FDA laws and regulations in the United States after entry. Clearly, however, this self-regulation of both imported and domestic products has not been successful and the FDA needs to be more involved in monitoring cosmetics.

Current Trends

The products sold at Claire’s and Justice were considered adulterated and misbranded because they contained asbestos. Although the FDCA contains similar provisions regulating drugs and food, the FDA has not been using its power to regulate the cosmetic market. Even though the FDA mentioned that it will change its approach to cosmetics, this is far overdue. The global cosmetics products market is expected to reach $805.61 billion by 2023. Makeup may be associated with young consumers, but one of the major drivers for the expansion of the cosmetics market is the aging global population. There is a strong desire among both men and women to retain a youthful appearance.

The trend towards beauty products with ingredients that are natural and pronounceable also presents a challenge to the FDA. In the last year, cosmetics free from parabens has grown 2.3%. The trend towards paraben-free and more natural makeup is challenging for the FDA because misbranding also includes what is stated on the label and what is omitted.

The rapid growth of the cosmetics industry and the rise in popularity of cosmetics from all around the world demands greater attention from the FDA. The FDA recently announced that they will work with cosmetics manufacturers and request information about how they ensure their cosmetics are safe and talc used in cosmetic products are free from asbestos, which is a start. However, as the cosmetics market continues to expand and evolve, the FDA will face more challenges, requiring more attention from the FDA.