Any consumer brand operator knows navigating from product development to warehouse inventory audits is a highly specific process.
Fortunately, at Factored Quality (FQ), we’re experts on all aspects of audits that founders and ops teams don’t have the capacity to worry about. And we’re going to outline all of them in this series.
In Part 7, we unpack the ins and outs of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and what it means for your brand.
Let’s dive in.
MoCRA is the FDA’s most significant cosmetics regulation since 1938
Signed into law on December 29, 2022, MoCRA is the most significant expansion of FDA authority in the cosmetics industry since the Federal Food, Drug, and Cosmetic Act in 1938.
The law arrived after over a decade of lobbying for product safety reform. Today, it ensures constant innovation to protect consumers from harmful cosmetics and personal care products.
MoCRA gives the FDA modernized federal regulatory oversight for product safety, including:
- Adverse Event Recordkeeping and Reporting: Manufacturers must keep records of any health-related adverse events for six years (three years for some small businesses) and report any adverse events to the FDA within 15 days after discovering the issue.
- Mandatory Facility Registration: Facilities that manufacture or process cosmetics products for distribution in the U.S. must be registered with the FDA.
- Product and Ingredient Listing: Cosmetics manufacturers must list each product with the FDA, including its ingredients and where it is manufactured.
- Cosmetics Safety Substantiation: Manufacturers must ensure a cosmetics product is “safe” and maintain records demonstrating “adequate substantiation” of safety standards. Products must meet these standards to be marketed in the U.S.
- Cosmetics Labeling and Fragrance Allergen Transparency: Cosmetics product labels (for both consumers and professionals) must identify each fragrance allergen in the product and include contact information to report potential adverse events. Professional product labels must state that only licensed professionals may use the product.
While some brands and manufacturers provide more product information than required by law, these good manufacturing practices (GMP) are now mandated under MoCRA. The law will improve transparency and align the FDA’s oversight standards for the beauty and personal care industry with other categories.
These regulations simplify how consumers understand cosmetics products, empowering them to make informed decisions about what is best for their needs.
Here’s how MoCRA could affect your cosmetics production
MoCRA preempts state and local laws that differ from federal law — enshrining the FDA’s expanded authority for greater consistency for consumers nationwide. The law does not prevent states from prohibiting or limiting the use of ingredients in cosmetic products.
This extensive reform of FDA cosmetics regulations entails a three-year implementation timeline: beginning in December 2023 and concluding by December 2025:
December 29, 2023
- MoCRA comes into effect
- Facilities are encouraged to register
The FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the Dec. 29, 2023, deadline.
July 1, 2024
- Facilities must be registered
- Existing products must be listed
- MoCRA will be enforced
June 29, 2024
- Fragrance allergens must be identified
December 29, 2024
- Labeling requirements enforced
No later than December 29, 2025
- FDA publishes GMP Final Rule
Beyond establishing new requirements for the industry, MoCRA provides the FDA with new authorities to enforce the law:
- Facility Suspension: The FDA can suspend a facility’s registration if a cosmetics product manufactured by that facility has a reasonable probability of causing serious adverse health consequences or death.
- Records Access: The FDA can access and copy certain records (i.e., safety records) related to a cosmetic product if the agency has “reasonable belief” that exposure poses a threat of serious adverse health consequences or death to humans.
- Recall Authority: The FDA has the authority to issue mandatory recalls if it is determined that a cosmetic product has been adulterated or misbranded and that exposure to the product will cause serious adverse health consequences or death.
Is every cosmetics producer expected to comply with MoCRA?
MoCRA does offer exemptions from GMP, registration, and product listing requirements to certain small businesses. A brand must be considered a “very small business” with average gross sales of less than $1 million over three years to qualify for an exemption.
However, these exemptions do not apply to manufacturers or facilities that manufacture or process the following cosmetic products:
- Injectable products
- Products intended for internal use
- Products that regularly come into contact with the mucus membrane of the eye under customary or usual conditions of use
- Products intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer
Factored Quality helps 100+ DTC brands maintain regulatory compliance
It’s crucial to stay ahead of regulatory changes and understand how they may impact your brand. At Factored Quality, we leverage the latest expertise to help 100+ leading consumer brands conduct comprehensive quality control.
With countless steps from selecting manufacturers to MoCRA compliance to safety testing, make sure you're doing everything possible to ensure consumer safety.
Book a personalized demo today.