On FDA Regulation of Cosmetics Products
Importers introducing cosmetic products into the United States must be mindful of FDA regulations, which can present a barrier to market entry if the appropriate steps are not taken to ensure compliance. The U.S. Food & Drug Administration (“FDA”) works in conjunction with the U.S. Customs and Border Protection (CBP) to monitor cosmetic products at the time of entry. Noncompliance with FDA regulations can result in a shipment being refused entry into the United States or a product being recalled from the market after entry.
However, one may mistakenly assume that cosmetic products are subjected to the same FDA scrutiny as foods or medical device products. In fact, this is not the case; instead, the FDA’s focus on the cosmetics industry differs from the regulation of other FDA-regulated products. Unlike the FDA’s regulation of many other FDA-regulated, cosmetic products and their ingredients (with the exception of color additives) do not require FDA premarket approval and registration or approval requirements are largely inapplicable.
Cosmetic Products and Import Alerts
Due to the high volume of cosmetics imported into the domestic market, as a practical matter, not all cosmetics are inspected or sampled upon entry into the country. Rather than implement blanket inspections, the FDA focuses its inspection efforts on potentially risk-laden products in addition to conducting inspections of randomly-sampled products. As part of these targeted efforts, the FDA issues Import Alerts, which provide a risk monitoring system for the FDA and a signal to importers on the agencies regulatory focus. According to the FDA, Import Alerts for cosmetic products focus on cosmetic products marketed with therapeutic claims, those that are adulterated with microbial contamination, and products which fail to meet FDA requirements for color additives. As explained below, issues surrounding color additives present one of the more complex and important regulatory issues in the cosmetics industry.
Cosmetic Products and Color Additives
Under the authority of the Federal Food, Drug and Cosmetic Act (“FFDCA”), cosmetic products containing color additives are subject to a strict system of approval prior to entering the market. Certain color additives must be batch certified by FDA if they are to be used in cosmetics. Although some colors are exempt from batch certification, these colors are considered artificial colors, and when used in cosmetics or other FDA-regulated products, they must comply with the identity, specifications, uses, restrictions, and labeling requirements stated in the regulations.
Further, all color additives must meet the requirements for identity and specifications. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product. With the exception of coal-tar hair dyes, failure to meet U.S. color additive requirements causes a cosmetic to be adulterated which may subject the product to removal from the market or detention. Accordingly, even when marketing cosmetics, there are important considerations from a FDA regulatory perspective, and compliance with these regulations will ensure smooth importation and marketing of cosmetics.
Navigating the web of regulations governing cosmetic products can be a daunting task. If you have any questions about FDA regulations or how these regulations relate to the marketing of a cosmetics products, please contact us at [email protected].
