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 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 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. 

 

Revealing the reality of cosmetics regulation—breaking news: it’s virtually nonexistent

The cosmetic industry’s 85-year record of relatively lax regulation and oversight contributed to several landmark examples of significant and even lethal consumer harm from unsafe products, including the massive litigation against Johnson & Johnson (“J&J”), a U.S.-based consumer healthcare and pharmaceutical business. Specifically, J&J’s talc-containing products, including baby powder, are directly linked to ovarian cancer and mesothelioma. Internal reports show that, since at least 1971, J&J was aware that their talc-containing products also contained asbestos, but only within the last couple of decades did the issue gain public traction, with the first lawsuit filed against them in 2009. As of 2023, there are over 38,000 lawsuits filed against J&J, all of which claim their products cause cancer. Famously, a Missouri jury awarded one of the largest personal injury verdicts in history–$4.69 billion– to 22 women who claimed J&J’s talc-based products directly caused their ovarian cancer.

 

The issues within the cosmetic industry were further amplified through various media platforms, particularly documentaries and television shows. For instance, “Not So Pretty,” a docuseries released in 2022, delves into the unregulated beauty industry and the undisclosed dangerous ingredients in everyday cosmetics. The negative media scrutiny was intense, and consumers demanded improved product safety and oversight. The market also began to take notice and a number of celebrities and entrepreneurs joined the “clean beauty movement,” advocating for and even marketing their own “clean” beauty products. The Honest Company, for example, was co-founded by actress, Jessica Alba in 2012 and claims to provide safe and effective products for children, cleaning, and personal care. In 2022, the company was estimated to have made about $314 million. But is this self-regulation model sufficient to protect consumers?

 

The FDA’s cosmetic oversight: the FDCA’s limitations and the need for change

Before the implementation of MoCRA last year, the Federal Food, Drug, and Cosmetic Act (FDCA), enacted in 1938, served as the sole regulatory framework for cosmetics under the FDA’s purview. The FDCA, however, often faces strong criticism for its lack of stringency in regulating cosmetics.  Under the FDCA, cosmetic products, such as moisturizers, shampoos, and deodorants, are considered “FDA regulated” rather than “FDA-approved,” indicating that these products do not require preapproval before entering the market. Additionally, the FDCA lacks mandates for the safety testing of products or their ingredients, and surprisingly, it does not grant the FDA the authority to initiate product recalls. The FDCA places a strong emphasis on self-regulation and gives little power to the government, stating that companies and individuals who manufacture cosmetics have the primary responsibility of ensuring the safety of their products. However, the J&J fiasco serves as indisputable proof of the shortcomings of self-regulation.

 

Shining a light on MoCRA—the future of cosmetic regulations

The MoCRA aims to address many of these concerns, as well as the FDCA’s shortcomings. First and foremost, MoCRA will now require companies to disclose the ingredients of their products to the public. Additionally, labels must now contain contact information for lodging consumer complaints, and further, companies must notify the FDA of serious problems with their product. MoCRA also aims to develop a standard for measuring whether talc products contain asbestos. Most notably, however, MoCRA now gives the FDA the authority to issue a mandatory recall of cosmetic products that are deemed unsafe.

 

Certainly, MoCRA is a giant leap in the right direction to ensure the safety of products on the market, but it has not been immune to scrutiny; safety standards would still reportedly be at issue. MoCRA’s language is not only vague, but still fails to require the FDA to run tests on products to ensure their safety. With most MoCRA provisions slated to take effect this December 2023, one year after enactment, the question remains: will MoCRA be effective in assuring the safety of cosmetic products in everyday use?

 

MoCRA, however, might encounter a comparable negative response as the FDCA did, particularly due to its almost non-existent testing standards. Those responsible for crafting future regulations in the cosmetic industry may contemplate the adoption of more stringent measures aimed at thwarting the release of hazardous products into the market. For instance, they could consider implementing randomized product testing conducted by the FDA to ensure compliance with safety standards. This move could potentially compel companies to take more responsibility for regulating their products, thereby contributing to a safer overall market. Only time and careful monitoring, however, will reveal to what extent MoCRA contributes to a safer and more transparent cosmetic industry.