July 17, 2015 Practice Points

Time for a Makeover: Newly Proposed Cosmetic Safety Legislation

By Whitney Frazier Watt

The use of cosmetic products is prevalent in American culture. In the United States, the cosmetics industry grosses more than 50 billion dollars per year. Both the widespread use of personal care products and frequent media reports of dangerous products in the market have incited public concern about the deficiencies in the regulation of cosmetics.

Currently, the Food and Drug Administration (FDA) is limited in its authority to regulate cosmetics. Under the Food, Drug, and Cosmetic Act and the Fair Packaging Act, the FDA regulates cosmetics to ensure that they are not adulterated or misbranded and may bring actions against hazardous products. Yet, the FDA does not require premarket approval for cosmetic products. Further, manufacturers are not required to register with the agency or disclose consumer reports of adverse effects. As a result, the safety of cosmetic products and the ingredients is regulated by the industry itself.

Many believe that the current federal laws inadequately protect consumers from harmful cosmetic products. Critics of the current scheme argue that the cosmetics industry is primarily concerned with its profits. Thus, the industry lacks the objectivity that is necessary to properly regulate the safety of products.

In response to such concerns, on April 20, 2015, Republican Senator Diane Feinstein (CA) and Democratic Senator Susan Collins (MA) introduced "The Personal Care Products Safety Act." This bill proposes a significant expansion of the FDA's authority to regulate cosmetics. Among its provisions, the bill would require facilities involved in the manufacturing, processing, packing, or holding of cosmetic products to register with the FDA. Additionally, cosmetic companies would be compelled to submit annual ingredient statements. The bill would also require that the FDA conduct a yearly evaluation of five ingredients found in cosmetic products to assess their overall safety. Further, the proposal would allow the FDA to recall harmful products and would mandate that companies submit annual reports about the adverse effects of each product.

To be enacted, however, the bill must overcome some obstacles. For over 70 years, federal law regarding the regulation of cosmetics has remained essentially unchanged and numerous attempts to pass similar legislation have failed. Nevertheless, this bill has qualities that distinguish it from previous proposals and make it ripefor adoption. First, the bill has gained support from numerous organizations. Supporters of the bill include industry giants such as Johnson & Johnson, Procter & Gamble, Revlon, Estée Lauder, Unilever, and L'Oreal. In addition, the Environmental Working Group, the Society for Women's Health Research, HealthyWomen, and the National Alliance for Hispanic Health have expressed their support. Another distinguishing characteristic is the bill's bipartisan support, several democrats and a republican have co-sponsored the bill. Finally, the bill proposes less stringent requirements than its historical equivalents. Notably, the bill does not regulate nanomaterials, sets reasonable objectives for the evaluation of ingredients, and does not require a full list of ingredients on the label of each product.

The bill, if enacted, will revolutionize the cosmetics industry. Opponents of the bill contend that the bill will cause companies to spend more in the research and development of products introduced into the market. They argue that increased spending in these areas may, in turn, increase the price of cosmetics for consumers and negatively impact small businesses. Proponents of more stringent regulations, however, maintain that the bill will benefit all involved parties, as it will promote more accountability within the cosmetics industry about the safety of personal care products and will increase quality standards for consumers.

Keywords: products liability, litigation, cosmetics, personal care, proposed legislation, safety, Dianne Feinsten, Susan Collins, Personal Care Products Safety Act

Whitney Frazier Watt is with Stites & Harbison PLLC in Louisville, Kentucky.


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