Understanding the 2022 United States Cosmetic Regulation Changes with MoCRA

Inside the 4155 pages of the Consolidated Appropriations Act, Congress overhauled the FDA's oversight and regulatory framework on cosmetics. The 36 pages tucked inside, referred to as the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), majorly amended the FD&C Act that has governed our industry since 1938.

This reform has been in the process for over a decade, and we've provided regulatory updates as any movement or progress happens. Now that reform is here, let's catch you up to speed!

First and foremost, let's make a few things clear:

• Nothing is immediately changing. MoCRA includes specific compliance dates for each change and directs the FDA to issue guidance or final rule changes. So, for now, we can only read and understand the new law and wait for the FDA to work towards implementing the changes and giving us compliance information.
• Most small businesses will be exempt from the most drastic changes. MoCRA includes all of the exemptions that industry advocates have fought for over the years, including longer timelines for implementation, special consideration for budgets and size, and being entirely exempt from more demanding requirements.
• Product type classification (soap or cosmetic) has not been modified or updated. If you make a true soap from saponified oils without making any claims about the product beyond cleansing, the existing FDA regulations do not apply to your product, nor does MoCRA. (Other laws do, though, and we teach that inside our program, Soapmaker to Moneymaker.)

August 2023 Update: The FDA has issued draft guidance for MoCRA and definitions of key terms, which can be viewed here. 

Let's go through each section of MoCRA and talk about the changes it makes to the existing FDA regulations, section by section.

Section 605: Adverse Events

Under MoCRA, you must report adverse events and maintain records of adverse events.

MoCRA requires that you accept reports of adverse events through your address, telephone number, or electronic contact information listed on your labels. When you receive an adverse event report, you must submit it to the FDA within 15 days. Any subsequent updates given to you within one year must also be reported within 15 days.

Companies must maintain adverse event reports for six years. However, small businesses qualify for a reduced three-year period of maintaining a record if their average gross annual sales for the previous 3-year period is less than $1,000,000 and do not make any of the following:

• cosmetics that come in contact with mucus membranes of the eye
• cosmetics that are injected
• cosmetics that are intended for internal use
• cosmetics that intend to alter the appearance for more than 24 hours

(Inside Soapmaker to Moneymaker, we already talk about adverse event record keeping, so these changes codify the suggestion and give specific timeline requirements for submissions and recordkeeping.)

Section 606: Good Manufacturing Practice

Under MoCRA, good manufacturing practices (GMP) will become required rather than implied.

The FDA is responsible for issuing proposed guidance within two years of enactment and final guidance no later than three years. However, the GMP guidelines issued by the FDA must include simplified requirements for smaller businesses like yours, ensuring that they do not impose undue economic hardship and may have longer compliance times.

Additionally, small businesses are exempt from mandatory GMP if their average gross annual sales for the previous 3-year period is less than $1,000,000 and do not make any of the following:

• cosmetics that come in contact with mucus membranes of the eye
• cosmetics that are injected
• cosmetics that are intended for internal use
• cosmetics that intend to alter the appearance for more than 24 hours

(Inside Soapmaker to Moneymaker, we already teach the current standard of GMP, including a lengthy self-audit checklist, and provide templates for creating batch records and SOPs. These will be updated to comply with any necessary changes when the FDA issues guidance.)

Section 607: Registration and Product Listing

Under MoCRA, registering your facility and product listings are mandatory.

Existing facilities have one year to comply with facility registration, while new facilities must register within 60 days in the future. Renewal for facility registration will be required every two years. Contract manufacturers are subject to registration for their facility. Any changes to your facility must be reported within 60 days.

Each product you make will require the submission of a cosmetic product listing detailing the ingredients, responsible party, and facility where it is manufactured. Existing products have one year to comply with listing submission, while new products will be required to submit within 120 days in the future.

Products similar in formulation with slight variations in color or scent do not require individual submissions. (For instance, if you make many different soap scents and/or colors from the same base formula, you will only need to submit one listing for your soap.) Updates must be provided annually.

Additionally, small businesses are fully exempt from facility registration and product listing submission if their average gross annual sales for the previous 3-year period is less than $1,000,000 and do not make any of the following:

• cosmetics that come in contact with mucus membranes of the eye
• cosmetics that are injected
• cosmetics that are intended for internal use
• cosmetics that intend to alter the appearance for more than 24 hours

(Many students inside Soapmaker to Moneymaker opt for voluntary registration, so we hope the FDA absorbs existing registrations for compliance.)

August 2023 Update: Previously registered businesses will need to re-register. The FDA has stated they will not transfer previous registrations. Read more here.

Section 608: Safety Substantiation

Under MoCRA, ensuring you can substantiate the safety of a cosmetic is required rather than implied.

This is defined as tests, studies, research, analyses, or other evidence considered by experts with qualified training to support the product's safety.

(Inside Soapmaker to Moneymaker, we already teach students to maintain safety records and documentation for every ingredient in their formulations. Based on the language of the law, these records should be sufficient.)

Section 609: Labeling

Under MoCRA, there are a couple of changes to the existing labeling requirements.

Electronic contact information has been added as an option to the responsible party's contact information.

Fragrance allergens must be outlined on the label. The FDA must issue proposed guidance within 18 months of the enactment and issue a final rule within 180 days after the public comment period of the proposed rule closes. The FDA can establish threshold levels subject to disclosure, and we may see something similar to the EU allergen disclosure rules.

Lastly, professional-use products must identify that they are for licensed professionals only on the label, and otherwise compliant with the existing labeling requirements.

Section 610 and 611: Records and Mandatory Recall Authority

These sections of MoCRA authorize the FDA to inspect facilities and their records and provide the FDA with the ability to enforce a mandatory recall on specific products that may be adulterated or misbranded and pose a public health risk.

(Inside Soapmaker to Moneymaker, we talk about developing recall procedures, so the additions to the regulations codify the need to have recall procedures in place.)

Sections 612 and 613: Exemptions

Section 612 dictates exemptions we have included in other sections for simplification. Section 613 clarifies that drug requirements must be met if a product qualifies as a drug.

Section 614: Preemption

MoCRA preempts state or local laws that differ from the federal framework on registration, product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation. This means no more patchwork legislation can be introduced in individual states, counties, or towns.

Other Notes

Section 3504 gives the FDA the ability to inspect records as needed.

Sections 3505 and 3506 direct the FDA to investigate talc and PFAS in cosmetics. 

The FDA must issue regulations requiring testing methods for detecting asbestos in talc-containing products, which our industry generally does not use talc. A proposed rule must be issued within one year after enactment, with a final rule following no later than 180 days after the public comment period closes.

The FDA must also assess the use of PFAS in cosmetics, gather scientific evidence regarding their safe use, and issue the assessment results in a public report within three years.

Section 3507 addresses animal testing by stating that we should be phasing it out as an industry when able to do so (which has been happening).

Section 3508 appropriates funding to the FDA for implementation.

Want to learn more?

As noted throughout this article, our current Soapmaker to Moneymaker students and graduates are poised exceptionally well in the face of regulatory changes and don't have anything to worry about! If you want to learn how to build your soap and skincare business from the ground up the right way, we're ready and waiting for you. We've already included regulatory updates inside the program and will continue to do so as the FDA issues final guidance.