The Modernization of Cosmetic Regulations Act (MoCRA) was signed into law by President Joe Biden on Dec. 29, 2022, but the US cosmetics industry is only now feeling the impact of the legislation coming into effect after being delayed, and delayed again. At Cosmoprof Las Vegas, Natalie Obermann, VP-global strategies, Personal Care Products Council (PCPC), detailed how the Act is impacting cosmetics companies.

“I’m getting the word out about this exciting reform taking place in the US,” explained Obermann. “The legislation puts new responsibilities on cosmetics companies and gives the US Food and Drug Administration new authority.”

What is MoCRA, Anyway?

The Modernization of Cosmetic Regulations Act (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Food Drug & Cosmetics (FD&C) Act of 1938. The law helps ensure the safety of cosmetic products used by consumers including makeup, haircare products, moisturizers, skincare, nail polishes, perfumes, face and body cleansers, shaving cream and other grooming products.

Obermann was quick to emphasize that MoCRA is NOT a pre-approval process.

MoCRA impacts a range of issues that have affected the cosmetics industry since the passage of the FD&C Act of 1938. Some of these issues include:

• Adverse Effects

• Labeling

• Fragrance Allergen Disclosure

• Safety Substantiation

• Good Manufacturing Practices

• National Uniformity

• Facility Registration and Product Listing

• Records Access, Facility Suspension and Recalls

• Talc Rule & PFAS Report

The speaker also provided a timeline of key MoCRA activities. Some of them, including adverse event reporting, safety substantiation, mandatory recall authority and professional use labeling remain unchanged and in effect. Others, like registration and product listing and testing methods for asbestos rule went into effect this year. In 2025, FDA will implement a labeling of fragrance allergen rule and labeling contact information. In 2026, MoCRA will implement a Good Manufacturing Practice Rule and issue a PFAS in Cosmetics Report.

Dive Deeper: Navigating MoCRA: Recent Updates and Key Strategies for Compliance

Key MoCRA Definitions

With this new legislation comes some affiliated jargon. Here are some of the most common terms used within MoCRA and how to make sense of them:

Responsible Person

Obermann also provided Key MoCRA definitions for a “responsible person.” The responsible person (RP) can be “a manufacturer, packer or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of [FD&C Act} or section 4(a) of the Fair Packaging and Labeling Act [FPLA].”

It includes international brand owners.

“We tell international companies that if you sell to a third party and the third party sells it in the US, you are impacted by MoCRA,” advised Obermann.

The RP does not have to be located in the US, and could be an individual, partnership, corporation or association. Interestingly, the RP cannot be a consultant.

Cosmetic Product

Under MoCRA, a cosmetic product is defined as a “Preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”

A cosmetic product is defined as final formulation before or after filling in a product container. It does not include cosmetic ingredients.

Facility

Under MoCRA a facility is defined as “any establishment that manufactures or processes cosmetic product distributed in the US. That includes international establishments and filling a product container with a cosmetic product. Moreover, according to FDA’s draft FAQ, it also includes batch release testing laboratories. It does not include R&D laboratories.

What “facilities” are exempt under MoCRA?

The list includes:

• Beauty shops and salons

• Retailers, direct sellers, retail distribution facilities & pharmacies

• Hospitals, physicians’ offices and healthcare clinics

• Public health agencies

• Entities that provide complimentary cosmetics incidental to other services, such as hotels and airlines

• Trade shows and other venues that provide free samples

• Establishments that manufacture cosmetics solely for use in research or evaluation, including production testing and not offered for retail sale

• Establishments that solely perform labeling, relabeling, packaging, repackaging, holding or distributing

And where does MoCRA place these new responsibilities?

For facilities, it includes facility registration and GMPs. For the RP, it includes product testing, adverse events, safety substantiation, labeling, fragrance allergen disclosure and fragrance record access. As already noted, while MoCRA does not impact ingredients, the RP could be clients of raw material suppliers. They could need information on fragrance allergen disclosure, fragrance record access and ingredient safety substantiation.

On July 1, 2024, facility registration and product listing requirements went into effect. Foreign facilities need a US agent so that FDA can get in touch with a representative.

“Owners or operators must register all their facilities that manufacture or process cosmetic products for distribution in the US,” noted Obermann. “Alternatively, any RP may register their contract manufacturers. (That) includes facilities located outside the US.”

The RP must list all cosmetic products marketed in the US, or must ensure that such are made—including brand owners located outside the US.

Adverse Event Reporting

MoCRA’s adverse event reporting requirement went into effect on Dec. 29, 2023. Companies must report adverse events, per use in the US, to FDA within 15 business days; plus “new and material” medical information within one year of report.

FDA is developing an electronic portal for adverse effect reporting, but for now, companies must submit FDA’s MedWatch 3500A Form. Adverse event records must be maintained for six years, subject to inspection. Certain small businesses must maintain adverse event records for just three years, according to Obermann. Further, MoCRA requires companies to ensure/maintain records supporting adequate safety substantiation.

“’Safe’ means a cosmetic product is not injurious to users under the conditions of use prescribed in the labeling thereof, or under customary or usual use,” Obermann said, adding it is the same as the current standard.

Some good news for industry is that MoCRA preempts any state or local laws that differ on registration, product listing, GMPs, records, recalls, adverse event reporting or safety substantiation. But states may limit or ban use of cosmetic ingredients in cosmetic products and may continue ingredient reporting requirements that predate MoCRA.

Record Access and Facility Registration Suspension

MoCRA gives FDA several new tools, including mandatory product recall authority by the Commissioner. These recalls will occur if there is a reasonable probability that a cosmetic is adulterated or misbranded, and the use of or exposure to such cosmetic will cause serious adverse health consequences.

MoCRA also gives FDA record access during routine inspections, but access is limited to adverse events and GMPs.

“If FDA has a reasonable belief that a cosmetic product or ingredient is likely to be adulterated and presents a threat of serious adverse health consequences, each responsible person and facility shall at reasonable times, limits and manner, allow FDA to have access to records necessary to determine if the cosmetics is adulterated,” explained Obermann. That access includes safety substantiation and shipment data, but does not extend to cosmetic formulas, financial, pricing, sales, personnel or research data.

MoCRA also gives the FDA Commissioner the authority to suspend facility registration. But the suspension can only occur if FDA determines that a cosmetic product distributed in the US has a reasonable probability of causing serious adverse health consequences and a reasonable belief that other products from the facility may be similarly affected because of a failure that cannot be isolated or is sufficiently pervasive. In addition, cosmetic products from facilities with suspended registrations may not be introduced into US interstate commerce.

MoCRA Exemptions

Obermann detailed several exemptions for registrations and listing.

Potential registration exemptions include:

• Did not manufacture cosmetic product on/after December 29, 2022

• No cosmetic product is for US distribution or produced in the US

• All cosmetic products are also drug or device

• Facility owner/operator is a small business

Listing potential exemptions include:

• Not marketed on/after December 29, 2022

• Not marketed for US interstate commerce

• Cosmetic product is also a drug or device

• Responsible person is a small business

The good news for small businesses is that they don’t need to list facilities or products if they meet certain requirements. MoCRA defines “small” as a business with average gross annual sales in the US for the previous three-year period of less than $1 million, adjusted for inflation.

However, the small business exemption does not exempt any business engaged in the manufacturing or processing of cosmetic products that:

• Come in regular contact with mucus membrane of the eye; e.g., “eye makeup remover,”  “liquid or mucosal eyeliner” or “false eyelash adhesive;”

• Are injected;

• Intended for internal use;

• Alter appearance for more than 24 hours and removal by the consumer is not customary; e.g., “certain nail polishes,” “some hair products,” “some eyebrow dyes” and “certain leave-on skin preparations.”

Ensure You’re Compliant: Prepare for the Modernization of Cosmetics Regulation Act

Registration and Listing Deadlines

Facilities must register within 60 days after engaging in manufacturing or processing for distribution in the US. The registration must be renewed every two years and updated within 60 days of any change, including a canceled registration. Product listings must occur within 120 days after the product is first marketed for the US. Listings must be renewed every year, with any updates, including a discontinued listing. Data must be submitted via Cosmetics Direct, the FDA’s MoCRA portal. Obermann explained that FDA removed some, but not all, validation codes in Cosmetics Direct that were requested by PCPC.

“We’re helping the industry with facility registrations and product listings,” she added.

Obermann warned that additional labeling requirements are expected by Dec. 29, 2024. These requirements will include a domestic (US) address or phone number or electronic contact information (such as a website) for adverse event reporting.

FDA has yet to determine new label disclosure requirements for fragrance allergens. Obermann noted that if there is reasonable evidence that a product or ingredient contributed to a serious adverse event, FDA may request the list of flavor/fragrance ingredients. The RP must ensure that requested information is submitted to FDA withing 30 days. However, FDA cannot disclose the fragrance list, she added.

FDA is also expected to introduce a draft regulation on Good Manufacturing Practices by the end of year.

“These regulations must be focused only on requirements needed to protect public health and ensure that cosmetic products are not adultered,” explained Obermann.

GMP regulations will be sufficiently flexible for all sizes and types of facilities and simplified requirements for smaller businesses; small businesses are fully exempt, she added. During Q&A, Obermann noted that FDA received more than 2000 comments with many noting that ISO is the global GMP standard.

“But we don’t know what FDA will do,” admitted Obermann.

Read More:  MoCRA Electronic Submission Portal Is Open

Key MoCRA Dates

Portions of the Act are already in effect. For example, serious adverse event reporting, safety substantiation and professional use labeling went into effect on Dec. 23, 2023. On July 1, registration and listing went into effect. Later this year, on December 29, contact information on labels for adverse events goes into effect.

Upcoming rules include a talc test method draft, which has been delayed. Similarly, a fragrance allergen draft has been delayed. A GMP draft is expected by Dec. 29, 2024 with a final GMP regulation by Dec. 29, 2025 (effective date to be determined).

While the arduous MoCRA process continues, the Personal Care Product Council continues to advocate for its members and the beauty industry, concluded Obermann. PCPC recently commended MoCRA funding for Fiscal year 2025, including a proposed $8 million.

“We’ve had substantive meetings with FDA and held working group meetings. PCPC continues to advocate for industry and partner with stakeholders.”