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 it specifically affect your company? 

 

MoCRA Registration & 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 it processes, packages, or manufactures cosmetics for commercial use in the United States, you must register with the FDA. 

Facility Registration Details 

All existing facilities subject to the new FDA MoCRA regulations are required to register within one year (December 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  

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 2023, while new cosmetics must list with FDA 120 days after introduction to commerce in the United States. 

 

Adverse Events — Recordkeeping & Reporting 

According to Section 605 of the MoCRA, you are now required to maintain records of as well as report 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 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 your cosmetics 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 a cosmetic company 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.  

 

MoCRA Exemptions 

Responsible persons such as facility owners and operators — or their responsible parties — that 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 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 

 

Enforcement of MoCRA 

With MoCRA, FDA is provided three new enforcement powers to help regulate the cosmetics industry: 

Full Preemption 

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. 

Facility Suspensions 

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. 

 

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. 

Discover how Registrar Corp can help you navigate the new FDA regulations and assist with everything from labeling updates to acting as your adverse event contact.