Food Drug and Cosmetic Act
On October 03, 2023, the Biden administration announced indictments and sanctions against 28 individuals and entities, including China-based companies and their employees related to the trafficking of chemicals needed for the manufacturing of fentanyl. The sanctions aim to interrupt the global supply chain of fentanyl as the administration have increased their efforts on tackling the opioid epidemic. However, rising tensions in the U.S.-China relationship have delayed progress. On September 15, 2023, President Biden added China to the list of the world’s major illicit drug producing and drug transit countries. In response, China’s Ministry of Foreign Affairs stated that the designation is a malicious smear against China. The Ministry further urged the U.S. to do things in ways that are conducive to cooperation with China, not otherwise. With growing international tensions and an epidemic still afoot, the U.S. faces a challenging uphill battle with fentanyl.
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.
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.
Regardless of opinions on legalization, many people accept the idea that medical marijuana, and more specifically CBD, can be a powerful treatment for many medical conditions. However, there has been one major roadblock: the FDA. According to the FDA, more than 90 warning letters over the past 10 years have been released to companies claiming that their cannabis products cure various symptoms. The most common is the claim that marijuana prevents or treats cancer. In 2017, as the medical properties of marijuana continue to be trumpeted to the general public, the FDA is still working to protect the public by issuing warning letters to marijuana providers making unsubstantiated claims.