Buried within the 4155 pages of the Consolidated Appropriations Act, a mere 36 pages redefine the standards within the U.S. beauty industry: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). For the first time in 85 years, Congress has finally passed legislation that drastically alters the Food, Drug, and Cosmetic (FD&C) Act, and it affects companies and individual consumers alike.
Signed and passed into legislation by President Biden on December 29, 2022, MoCRA grants the U.S. Food and Drug Administration (FDA) greater control over standards and regulations within the cosmetics industry.
For the consumer, this means greater safeguards, quality controls, and more transparency.
For cosmetic companies, MoCRA brings about stricter guidelines and reporting. Much of which has arguably been long awaited by consumers and welcomed by more ethical cosmetic companies.
But how does the new cosmetics act specifically affect your company?
FDA Registration & Product Listing Requirements
According to Section 607 of MoCRA, registering your facility and product listings is now mandatory. This is regardless of whether your facility is located in the U.S. or internationally. If your facility manufactures or processes cosmetic products for the U.S., you must register your facility with FDA using SPL format through Cosmetic Direct, their new electronic submission portal.
Facility Registration Details
Most existing facilities subject to the new FDA MoCRA regulations are required to register within one year (December 29, 2023) — this includes contract manufacturers.
New facilities must also register within 60 days and must renew every two years as required by FDA.
If there is a change to a facility, it must report those changes within 60 days.
Product Listing Details
According to MoCRA’s new requirements, each product produced now requires the submission of a cosmetic product listing that details everything from the ingredients — including fragrance or flavor, and responsible party to the facility of manufacture and its location.
Listing submissions are required to be submitted by December 29, 2023, while new cosmetics must list with FDA 120 days after introduction to commerce in the United States.
Adverse Events — Record Keeping & Reporting
According to Section 605 of the MoCRA, you are now required to maintain records of as well as report serious adverse events. FDA requires these records to be available should a product pose a potential threat to the public health. Upon identification of a threat, FDA now reserves the right to enforce mandatory recalls of these products.
Any adverse health-related event reports must be submitted to FDA within 15 business days — including any updates that follow within a year.
Adverse events are also required to be accepted through a U.S. address, telephone number, or electronic contact information supplied on each of your product labels.
This section of MoCRA also expanded FDA’s definition of a serious adverse event to better cover cosmetics as a whole.
The definition now includes:
- Significant disfigurement, including serious and persistent rashes
- Second or third-degree burns
- Significant hair loss
- Persistent or significant alteration of appearance
MoCRA Labeling, Safety, & GMP
Under MoCRA, FDA has also adjusted how labeling, safety substantiation, and Good Manufacturing Practices (GMP) are handled for the cosmetics industry. For example, a key change put forth is that all professional grade cosmetics must identify on the label that they are for sole use by licensed professionals.
Cosmetics Product Safety Substantiation
Substantiating the safety of cosmetic products is now required under MoCRA. That means your company must register all its products with FDA. You must also provide safety substantiation for all ingredients and formulas.
Your cosmetics may be “adequately” substantiated through documented research and analysis. Tests, studies, and any other evidence that can be qualified by an expert to support the product’s safety is also admissible.
Fragrance Allergens Disclosures
Gone are the days when cosmetic companies could simply list “fragrance” as an ingredient rather than list each of the ingredients in the fragrance. MoCRA now requires that any ingredient deemed an allergen by FDA must become listed and fully disclosed on the label.
Proposed guidance on this subject should be released within 18 months of enactment with a final rule within 6 months following the proposed rule’s close of public comment. Though specifics are not yet known, we may see significant similarities to allergen disclosure rules as in the European Union.
Compounding the lack of current clarity, labeling errors are the leading cause of detainment for importers. Discover how Registrar Corp can safeguard your bottom line once the new rule is in place.
Good Manufacturing Practices
GMP is also no longer implied for cosmetic companies but mandated by FDA under MoCRA.
Though there is not yet an established guidance as it pertains to MoCRA, FDA is required to supply GMP guidance within two years of enactment and final guidance within three years.
Once FDA enacts these new regulations, they will be the first federal regulations to require cosmetic companies to both install and adhere to GMP.
For smaller organizations, FDA is also required to supply simplified requirements ensuring the new GMP guidelines are not causing undue economic hardship. They may even grant a longer compliance window for qualifying entities.
Responsible persons such as facility owners and operators — or their responsible parties — that average gross annual sales in the United States less than $1,000,000 USD over the past three years are now defined as a small business under MoCRA.
These entities are only required to maintain adverse event reports for three years. They are also exempt from GMP, facility registration, and product listing requirements as set forth by MoCRA.
However, if a company manufactures or processes any form of a cosmetic product that falls into any of the below, it loses exemption regardless of annual sales:
- Cosmetic products that make contact with the mucous membrane of the eye
- Injectable cosmetic products
- Cosmetic products intended for internal use
- Cosmetic products intended to alter appearance for more than 24 hours
The Responsible Person Under MoCRA
According to section 609(a) of the FD&C Act — or section 4(a) of the Fair Packaging and Labeling Act — MoCRA defines a “responsible person” as the manufacturer, packer, or distributor of a cosmetics product whose name appears on the label of that cosmetic product.
The responsible person will be liable for Product Listings, Adverse Event Reporting, Product Labeling requirements, Safety Substantiation, Fragrance Allergen Disclosures, and Recalls.
Enforcement of MoCRA Law
With MoCRA, FDA is provided three new enforcement powers to help regulate the cosmetics industry:
MoCRA will now preempt any and all state or local laws that differ from FDA on product listings, adverse event reporting, facility registrations, records, GMP, recalls, or safety substantiation. MoCRA preemption also supersedes state mandates already in place like the California Safe Cosmetics Act and is intended to work as an extra layer of regulation.
This means no more introduction of jumbled legislation in individual states, counties, or towns.
Mandatory Recall Authority
Under the new regulations, MoCRA now authorizes FDA to inspect cosmetics facilities and their records. It also gives FDA the ability to enforce a mandatory recall on any products that they deem as misbranded, adulterated, or pose public health risks.
MoCRA gives FDA the authority to suspend a facility’s registration if it determines that a cosmetic product either manufactured or processed by that facility has:
- A reasonable probability of causing serious adverse health consequences
- Other products manufactured by the facility that may be similarly affected
Once a facility gets suspended, FDA will not allow introduction of any cosmetic products into United States commerce until the registration becomes reinstated.
How to Gain & Maintain MoCRA Compliance
It is clear MoCRA compliance is critical to the cosmetics industry and ensuring your product reaches the U.S. market without disruption. With the new expansion to FDA’s authority, it is imperative that companies begin preparations now to ensure product labeling, safety, and GMP standards are being followed before and as the new rules become finalized.
If you’re looking to keep your cosmetics company ahead of the MoCRA changes, Registrar Corp makes both MoCRA and your cosmetics R&D compliance quick and easy.
We’ve spent the last 20 years helping over 30,000 companies each year across 175+ countries understand the complexities of U.S. FDA regulations. From facility registration and cosmetic product listings to adverse event contact and reporting, we know how to help you navigate and achieve compliance.
Discover how Registrar Corp can help you navigate the new FDA regulations with ease.
Frequently Asked Questions:
What is MoCRA?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use daily.
Who is exempt from MoCRA?
Thanks to the long and hard work of the HSCG and others, there is an exemption in MoCRA for a “small business.” If your business qualifies, you are exempt from several provisions of MoCRA, including: Compliance with Good Manufacturing Practices to be issued in regulations. Facility Registration. Product Registration.
What is the MoCRA statute?
MoCRA provided new authorities to FDA including: Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.
What Did the Cosmetic Draft Guidance Cover?
FDA’s Cosmetic Draft Guidance established that cosmetic registration and listing data must be submitted electronically using the same format for submission of drug products: Structured Product Labeling (SPL) using their new Cosmetic Direct portal.