On December 29, 2022, President Joe Biden signed a massive $1.7 trillion omnibus federal spending bill into law. Most notably, as tweeted out by Biden, this comprehensive legislation focused on investing in medical research and safety, veteran’s healthcare, disaster recovery, funding for the Violence Against Women Act, and military aid to Ukraine. Importantly, the bill also establishes the Modernization of Cosmetic Regulation Act of 2022 (MoCRA), which according to Biden, is “the most significant expansion of FDA’s authority to regulate the cosmetics industry since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.” This legislation ushers in long overdue and stepped-up regulatory oversight, compliance, and consumer protection in the previously loosely regulated cosmetics industry. This blog will discuss the need for the updated regulations, the landmark litigation that illustrated the negative impacts on consumer’s health from an industry that was less than transparent and under-regulated, and the intent of the new legislation including if the legislation goes far enough to protect consumers from potentially harmful products.
Whether it is recognized or not, humans are exposed to a variety of products containing fragrances every single day. However, for something that is so common in the average human’s life, these chemicals are not as highly regulated as consumers would expect. While the Food and Drug Administration has requirements in place that fragrance formulas must meet in order to be incorporated in products, these formulas can also be considered “trade secrets.” This means that the formulas do not have to be disclosed to the public after FDA review. As a result, consumers should become more educated about potentially hazardous fragrance chemicals. These chemicals may lead to negative health consequences because they have gone unnoticed by the public.
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.
It is no secret that the beauty industry in America is frighteningly under-regulated. Cosmetics companies and beauty brands have managed to escape meaningful regulatory oversight for roughly a century and are largely left to self-regulate. In 2017, the global cosmetic products market was valued at $532 billion and is expected to reach a market value of $806 billion by 2023, registering a compound annual growth rate of 7.14%. Despite the colossal financial growth, regulatory shortcomings leave much to be desired by consumers. On the back of numerous harmful side-effects scandals and multi-million dollar class-action settlements, the FDA must grapple with renewed demand for cosmetics regulation as new beauty trends emerge.
The cosmetics industry, unknown to many, is essentially not regulated by a federal regulatory agency. Cosmetics technically fall under the purview of the Food and Drug Administration (“FDA”), but there are few requirements that manufacturers must comply with. The FDA only requires that manufacturers comply with several labeling regulations so companies can avoid listing a product’s total ingredients, and the FDA does not require manufacturers to report health complaints. The FDA instead relies on direct reports of adverse events from consumers, which has the potential to delay remedying a potentially dangerous situation. A study published in JAMA Internal Medicine found that between 2015 and 2016, the number of complaints of adverse health results related to cosmetic products more than doubled from the previous years. Additionally, the FDA only has the equivalent of six full-time inspectors to monitor three million shipments of cosmetics that come into the United States each year. Last year, inspectors only conducted tests on about 364 of those shipments, and 20 % of those shipment that were inspected led to adverse findings.