What is the Modernization of Cosmetics Regulation Act?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the first major amendment to the Food and Drug Administration’s (FDA) cosmetics regulatory framework in 85 years and sets federal standards for things like recalls and product listings.
The law was enacted Dec. 29, 2022 as part of the 2023 Consolidation Act to ensure that cosmetic product manufacturers provide assurances that their products are safe.
Since the legislation is so new, many companies are unsure of how (or if) this impacts them, and more importantly, how they can prepare and comply with the new FDA regulations. We’ll provide a high level overview of what MoCRA is, who it impacts, who is responsible, and how companies can start preparing to not only comply with the legal requirements, but the spirit of the law, which is to ensure consumer safety.
The introduction of MoCRA is the government’s way of standardizing how cosmetics organizations conduct business and how they maintain the safety of ingredients they are using within a regulatory framework. This is similar to how the FDA reviews food and drugs, where products, manufacturing processes, and labeling is more closely governed.
By the end of this year, all suppliers in the cosmetics industry will have to be compliant with facility regulations, product listings, serious adverse event (SAE) provisions, and safety substantiation.
Who Does MoCRA Impact?
The MoCRA amendment mostly impacts cosmetic manufacturers, importers, packers, and distributors of finished cosmetic products. Some small business entities are exempt from requirements, but many mid-size and large organizations will have to deal or participate in some aspect of MoCRA. For example, small businesses whose gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1M are not subject to Good Manufacturing Practices (GMP), registration, or listing requirements (but some restrictions apply).
MoCRA defines cosmetics products as “preparations of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”
MoCRA does not apply, however, to over the counter (OTC) drugs like sunscreens that make cosmetic claims. For such products, OTC drug regulations apply instead of MoCRA, except for new cosmetic provisions related to fragrance allergen disclosure and professional use labeling.
Who is Responsible for MoCRA
Part of MoCRA specifically calls out the concept of a “responsible person,” which in this case means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of the cosmetic product in accordance with 609(a) of the FD&C Act or 4(a) of the Fair Packaging and Labeling Act.
What are the Modernization of Cosmetics Regulation Requirements?
Good Manufacturing Practices
An important element of MoCRA is the concept of Good Manufacturing Practices (GMP), which provide guidelines on how to consistently and safely produce products that meet quality standards.
These are used in a variety of industries from pharmaceuticals to food and beverage.
According to MoCRA, the FDA must propose cosmetic GMP regulations no later than Dec. 29, 2024, and issue a final rule by Dec. 29, 2025. Furthermore, these GMP regulations must be consistent with current FDA and international standards (such as ISO 22716, which is a current GMP for cosmetics).
In anticipation of additional complexity, it’s important for companies to review existing requirements and standards used in facilities. MoCRA defines facilities as “any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the U.S.” There are some exclusions to this, such as beauty shops, cosmetic product retailers, or companies that relabel, pack, or repack products (as long as no filling is being done).
Mandatory product and ingredient listing
One of the biggest implications of MoCRA is around product and ingredient labeling requirements. Manufacturers, packers, or distributors of cosmetic products are required to list a cosmetic product’s ingredients and manufacturing information with the FDA.
- Products marketed prior to enactments of MoCRA must submit product listings before Dec. 29, 2023).
- Products first marketed after enactment must submit product listings within 120 days of marketing.
Furthermore, product listings must be updated annually. According to the legislation, “a single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations or formulations that differ only with respect to colors, fragrances, flavors, or quantity of contents.”
Adverse Event Recordkeeping
MoCRA extends beyond labeling to also include quality reporting, specifically around Serious Adverse Events to ensure product safety and preserve public health.
The legislation defines a serious adverse event (SAE) as “any event that is a result of death, life-threatening experience; inpatient hospitalization; persistent or significant disability or incapacity; a congenital anomaly or birth defect; and infection or significant disfigurement OR requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in the first definition of serious adverse event.”
Any serious adverse event associated with the use of a cosmetic product must be reported to FDA within 15 days after learning of the issue.
Companies must also provide any new and material medical information learned about the serious adverse event for one year following the initial submission to the FDA. They must also maintain records of any health-related adverse events associated with the use of the product for 6 years.
Effective Dec. 29, 2024, cosmetic product labels must include contact information through which the company can receive adverse event reports.
In Specright, companies can use the Quality Management module to log Serious Adverse Events, associate these records, and trigger corrective actions and reporting steps.
Safety Substantiation
In addition to maintaining records and documentation around SAE, MoCRA legislation requires that “records must be maintained that demonstrate adequate substantiation of the safety of the cosmetic product.”
Appropriate substantiation of safety includes tests/studies, research, analysis or other evidentiary measures or information that is considered, among qualified experts, adequate to prove a cosmetic or beauty product is safe.
These records need to be available to authorized FDA personnel to examine products if there is concern that a product is contaminated, poses a health threat or if an ingredient could cause harm. This requirement will have the greatest impact on small and medium-sized cosmetic companies that do not have qualified staff.
For many companies, they will need to obtain ingredient safety data from raw material suppliers. This will make collaborating and sharing data back and forth across the supply chain from brands, co-manufacturers, and suppliers critical.
In Specright, companies can store this critical data through Specright Files, which enables companies to easily manage documentation related to finished goods and individual specification components.
Labeling and Fragrance Allergen Transparency
Another critical labeling change is around fragrance ingredients and potential allergens.
Manufacturers, packers or distributors of cosmetic products are required to have information on file regarding the categories of chemicals contained in any fragrances used. A list of ingredients may also be requested by the FDA if there is suspicion that a fragrance/flavor contributed to a serious adverse event. Companies must provide lists of such ingredients or categories of ingredients within 30 days.
Cosmetic labels must also identify each fragrance allergen in a product in early 2025 after the FDA issues a fragrance allergen rule on June 29, 2024, with a 180-day comment period.
The FDA is considering international allergen listing requirements, such as those of the European Union. There are currently 26 such requirements, but it may expand to 82.
Another labeling change goes into effect Dec. 29, 2023, which, according to legislation, requires “professional cosmetics products to include the same information that is required of cosmetic products intended for sale to consumers and to state that only licensed professionals may use the product.”
In Specright, companies can manage ingredient listings and formula specifications and associate critical files, testing, and documentation in a digital, single source of truth.
Talc, PFAS and Animal Tests
Since MoCRA covers labeling and allergens, it’s only natural to wonder if it provides guidance on important topics like the use of animal testing and controversial ingredients like Talc, per- and polyfluoroalkyl substances (also known as PFAS). According to the EPA, “PFAS are widely used, long lasting chemicals, components of which break down very slowly over time.” There are health and safety concerns around using both talc and PFAS. While the initial passing of MoCRA does not give exact guidance at this time, it does say that the FDA must provide additional rules and guidance over the next few years.
For talc, the FDA must issue a proposed rule to establish and require standardized testing methods for detecting asbestos in talc-containing cosmetics by Dec. 29, 2023, with finalization 180 days after the comment period ends.
For PFAS, the FDA must assess the use of PFAS substances in cosmetics products and the scientific evidence regarding the safety of their use by Dec. 29, 2025 (although most U.S. states have banned PFAS in cosmetics by Jan. 1, 2025.
While animal testing doesn’t have specific guidance, it has been encouraged to be phased out except for “appropriate allowances.”
What are MoCRA Facility Requirements?
In addition to regulations around labeling, MoCRA also makes way for additional facility requirements, including Mandatory Facility Registration.
Mandatory facility registration
According to MoCRA, U.S. and foreign facilities that manufacture or process cosmetic products for U.S. distribution must register with FDA.
Existing facilities are required to complete registration within one year after the date of enactment of MoCRA. Any new facilities must register within 60 days from when they start production of cosmetic products or 60 days after Dec. 29, 2023 (whichever is later).
Furthermore, mandatory facility registration isn’t a one-time thing: all registrations must be renewed biennially.
MoCRA Exemptions
Oftentimes, new regulations mean new costs – but when passing MoCRA, congress was conscious that it wouldn’t add undue burden to small businesses. As such, they outlined specific exemptions to this new legislation.
Small businesses whose gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1M are not subject to:
- Good Manufacturing Practices
- Registration
- Listing Requirements
Small businesses must also maintain records of any health-related adverse events for 3 years, rather than 6 years.
There are some some small business exemptions that do not apply to companies with:
- Cosmetic products that contact the eye/eyeball
- Injectables
- Products intended for internal use
- Products intended to alter appearance for more than 24 hours
Federal Preemption
One thing to note about MoCRA is that it will preempt any state laws or local laws that differ to its framework, specifically regarding:
- Registration
- Product listing
- Good manufacturing practice
- Records
- Recalls
- Adverse event reporting
- Safety substantiation
The term “preempt” essentially means the higher level of government, in this case federal, has the authority to overrule the lower, in this case state, level. However, nothing prevents any state from prohibiting the use of an ingredient in a cosmetic product, or continuing requirement of any state in effect at time of enactment (e.g., CA Proposition 65, CA Safe Cosmetics Act).
New FDA Enforcement Authorities
Of course, regulations aren’t very effective if there aren’t any ways to enforce them. That’s why MoCRA has multiple provisions (and consequences) to ensure companies comply, including:
- Registration Suspension: Gives FDA the authority to suspend the registration of a facility if it determines that a cosmetic product manufactured by that facility has a reasonable probability of causing serious adverse health consequences (adulteration). If this happens, a facility cannot create new products until registration is restored.
- Access to Records: FDA has the authority to access and inspect records relating to a cosmetic product if it reasonably believes that a product or its ingredients are adultured and present a threat of serious adverse health consequences.This does not include information on recipes, formulas, financial data, etc.
- Recall Authority: Provides FDA with mandatory recall authority if it determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and exposure to the product will cause serious adverse health consequences or death.
How Companies Can Start Preparing for MoCRA
Evaluate how this regulation impacts your organization and identify compliance requirements
- Review, assess and communicate important MoCRA requirements and develop an implementation strategy that’s specific to your company
- Conduct gap analyses to understand changes that need to be made to current practices (develop a timeline and review activities that require longer lead times and/or additional resources)
- Stay up-to-date on on emerging FDA Proposed Guidances and rules, ask questions now and speak up to help these regulations take shape
FDA Guidance for Registration and Listing of Cosmetic Products and Facilities
On August 7, 2023, the FDA added draft guidance under the original MOCRA legislation, to provide additional recommendations and instructions for companies registering and listing cosmetic products and facilities. The additional draft covers a wide range of products, from makeup and nail polishes to perfumes and haircare products.
Prior to this draft submission of cosmetic product listings, ingredients, and production facilities was not required. The goal of this additional legislation is to ensure that all cosmetic information is readily available to further support the safety of all cosmetics.
This additional guidance to MOCRA will further pressure cosmetic companies to assess their impacts on their consumers and overall public health.
How Beauty and Cosmetics Companies Can Prepare for Increasing Cosmetics Regulation
One thing is certain: the FDA will only pursue additional rulemaking surrounding the governance of the cosmetics industry.
Over the next few months, impacted companies should start to evaluate the implications of this new legislation and identify compliance requirements.
Supplier collaboration will be especially important, and companies should start speaking with suppliers to facilitate compliance with safety substantiation requirements and fragrance provisions (e.g., allergens).
Companies should also get a head start on updating Standard Operating Procedures (SOPs) to close gaps between current practices and new requirements including AE/SAE reporting and record keeping, facility registration, product listing, safety substantiation, and labeling.
The general effective date for FDA enforcement is Dec. 29, 2023, which will be here before you know it.
And while there aren’t any user fees and, and this mostly impacts manufacturers, importers, packers, and distributors of finished cosmetic products, the law empowers the FDA to force mandatory recalls, which is a game changer from a brand and revenue perspective.
How Specright Can Help you Comply with MoCRA
Specright’s patented Specification Data Management (SDM) platform was designed as a single source of truth for critical product and packaging data.
You can easily collaborate and share data with suppliers, link specs to facility information, track adverse event reporting, and identity allergens and labeling requirements, and more.
Contact us to learn more about how a spec-first approach can help you comply with MoCRA.
