Exploring cosmetic chemical legislation changes in the US

Coming into law just days before the 2023 New Year, MoCRA was added to the Consolidated Appropriations Act, 2023 (H.R. 2617 – Public Law No: 117-328) only one week before its final passage. This may seem as though MoCRA snuck into the bill right before the finish line. However, as this is the first major piece of cosmetics legislation since the passing of the Federal Food, Drug, and Cosmetics (FD&C) Act in 1938, MoCRA has been a long time coming.

At first glance, the number of new requirements might seem daunting. This article’s objective is to break down those new requirements and offer tips and insights into how various stakeholders are being impacted.

The making of MoCRA

MoCRA has been in the works for years. It’s been championed by NGOs, clean beauty brands, and other industry advocates acting on behalf of a public concerned about the role chemicals play in their daily lives. These groups all share the belief that it’s the responsibility of government agencies to help regulate those chemicals and keep consumers safe.

Some examples of how MoCRA has been building momentum over the years can be seen when looking at prior bills introduced at the federal level.

The Personal Care Products Safety Act (S.2100), introduced in 2021, sought to require cosmetic brands and manufacturers to register with the FDA and to provide the department with additional regulatory authority to order mandatory recalls of cosmetics products, inspect cosmetics records, and more.

At the same time, the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2021 (HR 5538) focused on amending the FD&C Act to require brand owners to disclose information on fragrance ingredients, flavor ingredients, and fragrance allergens present in cosmetics products.

Neither bill moved past their initial introductions into the Senate and the House, respectively. However, the primary goal of each does appear in MoCRA.

Expanded FDA authority

MoCRA essentially helps to bring the Federal Food & Drug Administration’s (FDA) authority over cosmetics products more in line with other FDA-regulated consumer products.

Here are some of the main authorities MoCRA empowers the FDA with:

Product recalls

This new authority allows the FDA to issue mandatory product recalls for cosmetic products, kicking in one year after the bill’s enactment on 29 December 2023. The recall process outlined in MoCRA mirrors what the FDA implements for other product types. MoCRA also explicitly outlines that the FDA must allow responsible parties to voluntarily recall or discontinue the distribution of a harmful product before issuing the mandatory recall.

Facility inspections

Another authority the FDA will now be able to apply to cosmetics products more efficiently will be the ability to inspect facilities. The FDA has always had the authority to inspect registered facilities however, historically, manufacturing and processing facilities working only with cosmetics products were not required to be registered with the FDA. With new facility registration requirements implemented under MoCRA, not only will the FDA be able to conduct physical inspections (section 3504), but MoCRA also expands the FDA’s inspection authority to include all records and other information related to safety substantiation for ingredients and products.

Facility suspensions

If the agency determines that a product “has a reasonable probability of causing serious adverse health consequences or death to humans,” then the agency also has the authority to suspend a facility’s registration, which would prohibit the facility from distributing or selling cosmetic products from the facility in the US. This process mirrors the FDA’s authority to suspend food facility registrations for safety violations.

FDA regulatory obligations and their impacts

MoCRA also requires the FDA to issue three new rules on asbestos testing, good manufacturing practice (GMP) regulations, and PFAS testing.

Asbestos testing

One year after enactment, the FDA must issue a proposed rule to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. This means the industry can expect to see a draft proposal by the end of 2023. After publication, a new timeline will be initiated whereby the rule must be finalized 180 days after the public comment period on the proposed regulations is closed (section 3505).

Good manufacturing practice regulations

Two years after the enactment of the Act — 29 December 2024 — the FDA is required to propose GMP regulations for cosmetic products, with the finalization of the rules to follow a year later. The MoCRA regulations require the FDA to “consult with cosmetic manufacturers, including smaller businesses, consumer organizations, and other experts” to ensure the developed GMP regulations are consistent with national and international standards.

Additionally, the developed GMP considerations must be based on the size and scope of the businesses manufacturing cosmetics and the size and type of facilities in question. The first public virtual listening session for consulting with stakeholders was held on 1 June 2023.

Preparing for the FDA’s MoCRA GMP implementation

It’s important to note that GMP implementation can be challenging and time-consuming — so the earlier stakeholders can start to plan, the better. A good place to begin would be to consider the draft GMP guidance the FDA issued in June 2013. In the decade since this guidance was issued, concerns for product safety and technology have both advanced drastically, so it’s prudent to expect new regulations to be more comprehensive. However, it is a good starting point.

It’s also worth noting that GMP requirements are already in place for over-the-counter (OTC) drugs — such as sunscreens and dandruff shampoo — so these requirements could also serve as a frame of reference for those looking to do research ahead of the draft proposal. Once implemented, if a cosmetics product has been manufactured or processed under conditions that do not meet GMP requirements, it will be deemed adulterated.

PFAS safety and risks

While the FDA is working on these other developments, MoCRA also directs the FDA to assess the scientific evidence regarding the safety of, and risks associated with, the use of perfluoroalkyl and poly-fluoroalkyl substances (PFAS) in cosmetic products. This report, coupled with new industry reporting requirements, could help inform future federal regulations for these chemicals. The information on these findings is due to be finalized three years after MoCRA’s enactment on 29 December 2025 (section 3506).

New requirements for the industry

MoCRA formally obligates that the cosmetics industry implements what many prominent players have already been doing. The main requirements include:

Registration

MoCRA obligates manufacturers to register all facilities manufacturing or processing cosmetics products, with the following specifications:

• Facilities that existed before the passage of MoCRA have until 29 December 2023 to register.
• Any new facilities must register within 60 days of initial operations.
• Facilities in the supply chain who are not manufacturing or processing cosmetic products for distribution in the US are exempt from registering with the FDA.
• Registration is applicable to domestic and international facilities and must be renewed biannually.
• The FDA must be notified of any changes to the information included in the registration within 60 days of the change.

Marketing obligations

Each cosmetic product and its ingredients are also required to be registered.

• If the product was already on the market as of MoCRA’s enactment, it must be registered by 29 December 2023.
• Products first marketed after the enactment must be listed within 120 days of marketing.
• Product listings also require information on where the product is being manufactured.

These requirements apply to any manufacturer, packer, or distributor of a cosmetic product whose name appears on the label as defined within the regulation as a “responsible person.”

Additional industry considerations

For those who already have all the information they need to submit, plenty of new aspects of MoCRA are left to consider.

Labelling requirements

First, there are new labeling requirements, and not only for professional salon products, which now legally require “for professional use only” statements. All cosmetic products will be required to disclose all fragrance allergens, a list of which the FDA is required to issue by 1 July 2024. Additionally, labels must be updated to include contact information specifically for consumer adverse event reports.

Record keeping

For those without the infrastructure already in place to receive adverse event reports (and even for those who already have some program in place), this aspect of MoCRA could require a lot of internal resources. Companies must report any serious adverse events to the FDA within 15 days of receiving a report, and then maintain records of all serious adverse events for a minimum of six years.

Safety substantiation

The last compliance hurdle that stakeholders may face will be the new substantiation requirements for safety. MoCRA defines a cosmetic product as “safe” if it’s “not injurious to users under the prescribed conditions of use”. Under MoCRA, businesses must maintain records to demonstrate a “reasonable certainty” that a cosmetic product is safe. This substantiation could include tests, analysis, research, and more. Without adequate substantiation data, cosmetic products would be considered adulterated.