A Milestone in Cosmetic Safety: The Modernization of Cosmetics Regulation Act of 2022

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a monumental shift in the way cosmetic products are regulated in the United States; not since the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938  – the best part of a century ago – has there been such a comprehensive update. Given that the average American uses between 6 to 12 cosmetics products daily, the new legislation is particularly consequential.

Unveiling MoCRA: What it Means for Consumers and Manufacturers

MoCRA grants the FDA several new authorities, ranging from the ability to access and copy safety records, to the power to enact mandatory recalls. Manufacturers, packers, or distributors – referred to as ‘Responsible Persons’ in the Act – are now required to report ‘Serious Adverse Events’ to the FDA within 15 business days. This requirement aims to increase transparency and bolster consumer safety.

Additional industry requirements under MoCRA include facility registration every two years and mandatory product listings with the FDA, including specific ingredient information. Furthermore, should a facility’s registration be suspended due to safety concerns, it becomes illegal to sell any products from that facility in the United States.

Cosmetic Industry Under Scrutiny: Why MoCRA is Crucial

The push for updated regulation comes amidst rising concerns about harmful substances in cosmetics. Asbestos, now a well-known, insidious carcinogen, has been a significant point of concern, particularly when found in talc-containing products, such as everyday powders and eyeshadows. MoCRA mandates standardized tests for detecting and identifying asbestos, providing a level playing field and setting a uniform safety standard.

The Importance of Asbestos Testing in Makeup

Asbestos exposure can lead to serious health problems, including lung cancer and mesothelioma; therefore, the standardized testing for asbestos is one of MoCRA’s key provisions. While the FDA is still working on developing a standardized testing methodology, the overall objective is crystal clear: to prevent ‘Serious Adverse Events’ resulting from exposure to harmful substances.

The Controversial Talc-Asbestos-Cancer Link

Doctors who claim to have uncovered a compelling link between talc and various forms of cancer (particularly ovarian cancer) have found themselves in hot water, with legal battles being hurled at them from corporation giants like Johnson & Johnson. In these lawsuits, Johnson & Johnson has taken legal action against these professionals, arguing that their claims are not supported by sufficient scientific evidence to warrant the accusations. The controversies around talc raise important questions about the level of scrutiny needed in the cosmetics industry.

Using caution in selecting your cosmetics

To minimize the risk of exposing yourself to harmful chemicals when using makeup or other cosmetics, you can consider the following approaches:

• Familiarize yourself with brands that have been identified as manufacturers of asbestos-containing makeup and personal care products

• Opt for cosmetics that are specifically labeled as talc-free

• Conduct asbestos testing on your products

While asbestos testing might be the least budget-friendly option among the three, it offers the most certainty that your talc-based products are free from asbestos; test kits for asbestos are available online for this purpose.

Alternatively, if you prefer not to invest time in testing the chemical composition of your cosmetics, you can instead focus on researching and choosing brands that are both talc-free and asbestos-free for the simplest route to peace of mind.

Although it is not yet definitively proven whether asbestos-contaminated talc contributes to ovarian cancer, the comprehensive framework offered by MoCRA may pave the way for more thorough investigations into such health concerns. This framework could be critical in providing the kind of robust, evidence-based conclusions needed to resolve ongoing debates and legal battles.

Mandatory Adverse Event Reporting: Why it Matters

The adverse event reporting process outlined by MoCRA is a significant departure from prior practices, which were voluntary and often opaque; this system aims to bring about much-needed transparency and accountability.

A comprehensive electronic reporting system is being developed to manage these health-related complaints better, and it will be accessible through the FDA’s Safety Reporting Portal (SRP).

Small Business Exemptions: A Balanced Approach

MoCRA also takes into account the unique challenges faced by smaller businesses by offering exemptions from certain requirements like Good Manufacturing Practice (GMP), registration, and product listing. However, these exemptions are certainly by no means to be considered as blanket allowances; they do not apply to manufacturers of certain high-risk cosmetic products, such as those that come into regular contact with sensitive areas like the eyes’ mucus membranes.

The Future of Cosmetic Safety: What Lies Ahead

The FDA stopped its Voluntary Cosmetic Registration Program (VCRP) as of March 27, 2023, signifying a commitment to the more stringent requirements under MoCRA. For consumers, this signals an impending increase in the overall safety standards in the cosmetics industry.

The Act also requires stricter industry compliance with new FDA regulations around Good Manufacturing Practice (GMP), as well as fragrance allergen labeling requirements, emphasizing its comprehensive nature. These future-focused provisions ensure that the Act will have a lasting impact on cosmetics safety.

Conclusion: A New Era in Cosmetic Safety

The Modernization of Cosmetics Regulation Act of 2022 serves as a cornerstone for consumer safety in an industry that, given its nature, likely impacts virtually every American. These welcome new rules aim to bring about the kind of transparency, accountability, and scientific rigor that has, sadly until now, been woefully lacking; they represent an ginormous step toward resolving longstanding safety debates, including the asbestos-talc controversy and more.

Although the Act may not resolve every issue immediately, it certainly does lay the groundwork for a safer, more scrutinized, and better-regulated future for the world of American cosmetic products.