In the first major update to the Food, Drug and Cosmetic Act since the 1930s, Congress sent a bill to President Biden’s desk that takes meaningful updates to an outdated industry. If you’re new to the issue, here is a quick primer on how toxic chemicals are frequently used in personal care and cosmetic products and to understand the existing policy flaws this bill seeks to address, check out this article.
The bill is called the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and was included in a large omnibus spending bill that helped avert a government shutdown. While the legislation has about 65% of the reforms needed to fully protect consumers, the timing of this was critical. Had Congress failed to pass these provisions, due to a split Congress and the following Presidential election, realistically we would have had to wait another five years for reform to pass.
As someone who has been on the front lines of lobbying for this bill since I first arrived in DC in 2009, I’m proud of what ended in the final compromise. (Picture above of the Beautycounter team, led by Gregg Renfrew, during one of our many Congressional Briefings on the need for reform. I led the company’s advocacy efforts for nearly eight years.)
Key Provisions Included in MoCRA:
Adverse Event Recordkeeping and Serious Adverse Event Reporting
Adverse events are considered when immediate harm happens as a result of the use of a cosmetic product. Newly added Sec. 605 requires companies to keep adverse event files on hand for six years and expanded what is considered a “serious adverse event” as “significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual.” The reason this is important is because there have been several instances of serious adverse events where the FDA previously had no recourse to act, including Wen Haircare’s shampoo which led to permanent baldness. In addition, companies have 15 days to report serious adverse events to the FDA.
Mandatory Registration and Product and Ingredient Listing
To date, the FDA didn’t know exactly who and where cosmetic products were made, which makes proper inspection and audits impossible. In newly added Sec. 607, contract manufacturers must register with the FDA and perhaps most importantly they need to annual report to the FDA which products they make and which ingredients are in them. If and when issues arise, the agency will quickly be able to identify who made a product and an action next steps to quickly protect consumers.
Cosmetic Safety Substantiation
Perhaps one of the most important parts of the legislation seems quite simple, brands will now need to have adequate safety substantiation on file showing how an ingredient is safe and at what levels. This will address one of the largest issues within the industry, which is rubber stamping of ingredients and the assumption that they are safe since they have been used for decades. Any ingredients that don’t have safety substantiation on file the FDA will consider the product adulterated, which provides them the regulatory ability to ask pressing questions. You can see how this could be particularly helpful with highly toxic chemicals used in products like PFAS, which are persistent and toxic or formaldehyde releasing preservatives (Sec. 608).
Fragrance Allergen & Professional Salon Ingredient Transparency
Similar to the EU, the FDA is required to create a rule for disclosure of known fragrance allergens. This is particularly helpful for sensitive populations or people undergoing chemotherapy. Mirroring legislation I helped advocate for in California, the bill requires professional salon products to have the same level of disclosure as products sold at retail, which includes all ingredients with the exception of fragrances. Both of these provisions are major improvements to existing law (Sec. 609).
Mandatory Recall Authority
For the first time the FDA will be able to demand a recall of a product that has egregious health implications. Examples from recent history of when this authority would have been used include: asbestos in children’s makeup, formaldehyde in hair straightening treatments, mercury in skin lightening creams, and shampoos that cause permanent baldness. To date the FDA has only been able to request a voluntary recall by the company, and in most of the instances listed above, the companies chose to leave the toxic products on the market (Sec. 611).
Clarity for OTC Drug & Cosmetic Jurisdiction
In Sec. 613, the bill makes it clear that when a product is both OTC and used for personal care—like sunscreens and acne treatments—they are regulated by OTC standards (which are more stringent).
Updates to Good Manufacturing Practices
Cosmetic Good Manufacturing Practices (cGMPs) are standards and protocols used by manufacturers to ensure clean facilities that help reduce issues with stability, microbial growth and more. The FDA is required to create a rule (which uses a process called rulemaking where stakeholders like individuals, companies and nonprofits can weigh in) that updates these standards. While this isn’t an improvement to ingredient safety, it will make products overall safer due to better manufacturing standards (Sec. 606).
PFAS and Talc
Standardized testing for asbestos in talc supplies is included which addresses a large issue with contaminated talc used in cosmetics and differing testing methodology (Sec. 3505). This will reduce confusion and the ability for brands to skirt responsibility for asbestos in their products. The FDA is also directed in Sec. 3506 to review the use of and safety of PFAS in cosmetics and generate a report on their position on this toxic and persistent class of chemicals used in longwear makeup. For consumer safety advocates this is an important step towards banning the class of chemicals outright.
One of the hotly debated provisions, the law does include some limited preemption of state laws, which is an expected trade off for federal legislation. The question is always, how severe is the state preemption? In this instance, states are prohibited from passing new legislation that is covered in the federal law including: registration, good manufacturing practices, records, recalls, adverse event reporting or safety substantiation. States can continue to pass explicit bans on toxic chemicals, protections for overexposed communities like people of color and transparency requirements that help close the fragrance loophole. Preemption is not the same as a rollback, it just prevents the states from going further than the FDA for the areas of statute updated. The importance of this limited preemption is important since it still allows states the ability to pass laws on the remaining areas not yet covered by federal law (Sec. 614).
Facility Suspension & Records Access
The FDA has the ability to suspend registration at a manufacturing facility, giving the agency new authority to take action if serious adverse events or other issues arise (Sec. 607). They are also given new oversight and power to ask brands to share records when safety threats transpire (Sec. 10).
Resources for FDA
Without the use of user fees (when companies have to pay in to fund the program) the law authorizes funding to fund the FDA for these updated programs. This is a welcomed improvement as it was reported in 2017 that the FDA only had 6 inspectors overseeing 3 million shipments of cosmetics.
There is much more work to do and much to celebrate. While we need to continue to push for outright bans of toxic chemicals in cosmetics, increased protections for women of color who bear the larger burden of toxic chemical exposures, and close the fragrance loophole, we should also pause to celebrate. This is a huge step forward to make personal care products safer.