A young cosmetics manufacturer observes a new product as he contemplates the impact of MoCRA on his business.
Author

Jaclyn Bellomo

Senior Director of Cosmetic Science and Regulatory Affairs

The Complete Guide to MoCRA: Cosmetics Regulations 101

Jun 12, 2023

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).

This transformative legislation, signed into law by President Biden on December 29, 2022, significantly enhances the FDA’s oversight of cosmetic safety and consumer transparency. It represents the most extensive update to cosmetic regulations since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.

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, particularly the MoCRA labeling requirements and MoCRA small business exemption, specifically affect your company?

FDA Registration & Product Listing Requirements

According to Section 607 of MoCRA, registering your facility and complying with MoCRA product listing requirements 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 the 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 be listed 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, the FDA has made significant adjustments to labeling requirements, safety substantiation, and Good Manufacturing Practices (GMP) within the cosmetics industry.

A pivotal part of these new requirements is the MoCRA safety assessment, which demands comprehensive safety substantiation for all cosmetic ingredients and formulas. Each product must undergo rigorous safety checks validated through documented research and expert analysis, ensuring it meets the highest consumer safety standards.

For example, it is now mandatory for all professional-grade cosmetics to explicitly state on their labels that they are for use only by licensed professionals. Additionally, the MoCRA fragrance allergens disclosure requirements mean that any allergenic ingredient in fragrances must now be fully listed on product labels.

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 each of the ingredients in the fragrance. MoCRA now requires that any ingredient deemed an allergen by FDA must be listed and fully disclosed on the label.

In addition to fragrance allergen disclosures, MoCRA mandates a comprehensive safety assessment for all cosmetic products. This assessment ensures that each product is adequately substantiated through scientific studies and expert opinions, confirming that they pose no harm to consumers.

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 howRegistrar Corp can safeguard your bottom line once the new rule is in place.

Good Manufacturing Practices

Enhanced Good Manufacturing Practices, especially MoCRA GMP, are no longer implied but mandated under the new regulations. These practices are critical for ensuring product safety and compliance.

Though there is not yet 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

Understanding the MoCRA small business exemption is crucial for smaller enterprises operating within the U.S. cosmetics industry.

Under MoCRA, businesses and 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 and are exempt from several stringent requirements.

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:

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.

Overview and Timeline of MoCRA Implementation

The MoCRA, detailed in a concise summary, equips the FDA with robust tools to enforce cosmetics safety. Essential dates include mandatory product listings and facility registrations by December 29, 2023, and stringent adverse event reporting protocols.

Companies must now meet heightened safety assessments, involving detailed documentation and expert evaluations, to verify product safety before market introduction. These measures streamline the safety verification process and set a new standard for industry accountability.

How to Gain & Maintain MoCRA Compliance

It is clear MoCRA cosmetics regulations grant the FDA unprecedented control over standards and regulations within the cosmetics industry and compliance is critical to 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.

Stay ahead of these transformative MoCRA regulations—from product labeling to safety compliance—with Registrar Corp’s expert guidance.

We’ve spent the last 20 years helping over 30,000 companies each year across 190+ 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 About MoCRA:

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.

 

Author


Jaclyn Bellomo

Senior Director of Cosmetic Science and Regulatory Affairs

A seasoned expert on the cosmetic industry, Jaclyn's deep understanding and insights on cosmetic regulations brought on with the passage of the Modernization of Cosmetics Regulation Act (MoCRA) are unmatched. Her experience and reputation throughout the global cosmetic industry helps companies worldwide meet the newly enacted FDA regulations under MoCRA.

Related Article


Subscribe To Our News Feed

To top
This site is registered on wpml.org as a development site. Switch to a production site key to remove this banner.