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MoCRA and new FDA regulations for cosmetics

Since being signed into law in December 2022, the Modernization of Cosmetics Regulations Act (MoCRA) has brought about significant changes to the cosmetics industry in the United States. MoCRA introduces a new legal framework, focusing on enhancing safety and transparency for consumers. In this article, let’s explore with GOL the impacts of MoCRA on cosmetics businesses and consumers, as well as the necessary preparations to comply with the new regulations.

What is MoCRA?

On December 29, 2022, President Joe Biden signed into law the Modernization of Cosmetics Regulations Act of 2022 (MoCRA), as part of the Consolidated Appropriations Act of 2023. MoCRA provides the FDA with a broader legal framework to regulate the cosmetics industry and marks a significant change since the passage of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938.

The MoCRA Act has elevated the FDA’s authority in managing the cosmetics industry to the level of other industries regulated by the FDA, such as pharmaceuticals, medical devices, and food.

MoCRA includes provisions such as cosmetics registration, product listing, new labeling requirements, record-keeping, adverse event reporting, safety substantiation, Good Manufacturing Practices (GMP), and the recall of adulterated cosmetics, misbranded cosmetics, or cosmetics containing harmful ingredients.

Numerous new regulations have been enacted, imposing obligations on cosmetics manufacturers, packagers, distributors, and those who place or attempt to introduce cosmetics into the U.S. market to comply with.

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The New Regulations of the MoCRA (Modernization of Cosmetics Regulations Act)

Registration and Renewal of Cosmetic Manufacturing Facilities

According to the Modernization of Cosmetics Regulations Act of 2022 (MoCRA), registration with the FDA is mandatory for owners and operators of facilities involved in manufacturing or processing cosmetics for distribution in the United States. This registration needs to be renewed every two years.

  • For existing facilities: There is a one-year period from the enactment date to register the facility with the FDA.
  • For new facilities: Registration must occur within 60 days of commencing product distribution or 60 days after the registration deadline, whichever comes later.

Facilities must notify the FDA of any changes to registration information within 60 days of the change, and FDA registration must be renewed every two years.

Listing of Cosmetic Products

According to the Modernization of Cosmetics Regulations Act of 2022 (MoCRA), FDA registration is mandatory for owners and operators of facilities involved in manufacturing or processing cosmetic products for distribution in the United States, with registration renewal required biennially. Existing facilities have one year from the date of enactment to register their facility with the FDA. New facilities engaged in manufacturing or processing cosmetic products for distribution in the U.S. after the enactment date must register within 60 days of marketing a product or 60 days after the registration deadline, whichever is later.

Facilities are required to notify the FDA of any changes to registration information within 60 days of the change and renew their FDA registration every other year.

Good Manufacturing Practices (GMP) for Cosmetics

The Modernization of Cosmetics Regulations Act of 2022 (MoCRA) mandates that cosmetic manufacturing facilities adhere to Good Manufacturing Practices (GMP). GMP aims to safeguard public health and ensure that cosmetic products are free from contamination. This regulation allows the FDA to inspect facilities and access records deemed necessary to verify compliance with GMP established by the FDA.

At present, the FDA has a period of 2 years following enactment to release a Notice of Proposed Rulemaking regarding Cosmetic GMP. The Final Rule must be issued no later than 3 years after enactment.

Good Manufacturing Practices (GMP) for Cosmetics

New Requirements for Cosmetic Labeling

Cosmetic product labels must now include a domestic address, domestic phone number, or electronic contact information where a responsible person can receive adverse event reports.

Cosmetic products containing fragrance allergens must update their labels to list these allergens. Proposed fragrance allergens must be issued within 18 months of the enactment date, with the final ruling issued no later than 180 days after the close of the public comment period.

For professional cosmetic products, labels must prominently state that the product is intended for use only by licensed professionals and complies with existing cosmetic labeling requirements.

The new labeling requirements will come into effect as follows:

Within 1 year: Labels of professional cosmetic products must include all mandatory information and explicitly state that only licensed professionals are authorized to use the product.

Within 2 years: Labels must include contact information for the responsible person for adverse event reporting and must identify allergens from fragrances as determined by the FDA.

Reporting Adverse Events

Serious Adverse Events refer to adverse events that:

(A) Result in:

  • Death;
  • A life-threatening experience;
  • Inpatient hospitalization;
  • A persistent or significant disability or incapacity;
  • A congenital anomaly or birth defect;
  • An infection; or 
  • Significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual;

(B) Require, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (A) above.

In case of a Serious Adverse Event linked to a cosmetic product, the responsible person is required to submit a report, along with a copy of the label on or within the retail packaging, no later than 15 business days after receiving the report.

If a company obtains new and significant medical information related to the report within one year of the initial report, it must promptly submit this information to the FDA within five business days of receiving it.

Reporting Adverse Events - Mocra

Cosmetic Safety Assurance: Ensuring Consumer Peace of Mind

The Modernization of Cosmetics Regulations Act of 2022 (MoCRA) requires cosmetic companies to maintain comprehensive safety records for their products. This is a significant milestone in safeguarding consumer health and ensuring transparency in the cosmetics industry.

MoCRA defines “safety substantiation” as “tests, studies, analyses, or other evidence or information evaluated by qualified scientific and experienced experts to reasonably support the safety of cosmetics and their components, sufficient to provide reasonable certainty that a cosmetic product is safe.”

This means that cosmetic companies cannot simply claim their products are safe without supporting evidence. Instead, they need to:

  • Conduct appropriate scientific research: This may involve clinical trials, toxicity studies, and risk/benefit assessments.
  • Maintain comprehensive records: These records must include all data and documents related to the safety substantiation of the product.
  • Be willing to cooperate with the FDA: If the FDA requests additional information about the safety substantiation of the product, the company must be prepared to provide it.

Safety substantiation for cosmetics is a significant responsibility for companies. By complying with the requirements of MoCRA, companies can help build consumer trust and ensure the safety of the community’s health.

Cosmetic Safety Assurance

Inspection of Cosmetic Records

Empowers the FDA to access and duplicate specific records concerning a cosmetic product if there is a reasonable suspicion that the product or its ingredients pose a risk of serious adverse health effects or death to humans upon use.

Mandatory Recall Authority

The U.S. Food and Drug Administration (FDA) has the authority to mandate the recall of cosmetic products in certain serious cases. Here is a summary of the conditions and procedures for recall:

Conditions for recall:

FDA determines there is a reasonable probability that the cosmetic product:

  • Is contaminated: Contains harmful or unsafe ingredients.
  • Is mislabeled: Information on the product label is inaccurate or misleading.

The use or exposure to this cosmetic product may cause serious health hazards.

Record-Keeping for Cosmetic Adverse Event Reports

Records of adverse event reports must be retained for a period of 6 years, and the FDA must have access to them during inspections. If the FDA suspects that an ingredient or combination of ingredients in the product’s fragrances or flavors has caused serious adverse events, it may request a written list of all ingredients. This list must be provided within 30 days of the FDA’s request.

Some cases are exempted

The Modernization of Cosmetics Regulation Act (MoCRA) offers certain exemptions for small businesses from complying with Good Manufacturing Practices (GMP), facility registration, and product listing requirements. However, these exemptions do not apply to manufacturers or facilities that produce or handle specific types of cosmetic products deemed higher risk. These include:

  1. Eye Contact: Products that, under normal use, regularly come into contact with the mucous membrane of the eye.
  2. Injectable Products: Products intended for injection.
  3. Internal Use: Products intended for internal consumption.
  4. Long-Lasting Appearance Alteration: Products that significantly alter the user’s appearance for more than 24 hours under normal use, even if removal is not part of the intended use.

Additionally, certain products and facilities subject to drug or device regulations may also qualify for exemptions.

Remember: Even if your business falls under the small business exemption category, it’s crucial to carefully review the details and ensure your products don’t fall into any of the excluded categories. If you’re unsure, consulting with a regulatory expert is always recommended.

Some considerations when MoCRA is enacted

With the enactment of the MoCRA, there may be some significant changes as follows:

FDA has the authority to initiate recalls of dangerous cosmetic products

Until now, the FDA couldn’t mandate the recall of beauty products containing harmful substances like asbestos and lead on the market. Therefore, brands have been slow to voluntarily recall beauty products under the new MoCRA law enacted earlier this year.

Some types of sunscreen lotions, spray-on dry shampoos, and dry conditioners have been recalled after an independent laboratory found them contaminated with benzene, a highly carcinogenic substance to humans. Additionally, various moisturizers and cleansing agents sold in bulk have been recalled because they contained bacteria that could harm the health of consumers.

Before the advent of the MoCRA, the FDA may have requested some companies to recall their products, but they were not compelled to do so. Therefore, the new law has been amended to allow the FDA to request companies to submit cosmetic safety reports and specifically recall unsafe products.

cosmetic products - Mocra

Consumers may become more aware of other hazardous ingredients in cosmetics

MoCRA will conduct more frequent checks on cosmetic companies. Hazardous substances such as mercury, lead, benzene, and asbestos are expected to be reviewed by the FDA in all types of cosmetics by the end of 2025. Products containing talc (such as finely powdered minerals) are closely monitored for asbestos in these types of cosmetics.

You may read more articles about harmful ingredients in beauty products in the future. Manufacturers do not, however, recommend testing products to detect cancer-causing agents below the level that the FDA considers “safe”.

Even extremely hazardous ingredients like benzene and mercury can be present at FDA-approved safe, non-toxic levels in everyday cosmetic products.

All ingredients of the product must be disclosed in the ingredient list

Previously, some irritants in beauty products may not have been listed in the ingredient list. A classic example is the ingredient list of perfumes often not being fully disclosed, and stimulants are often hidden under the term “fragrance” commonly found on many perfume bottles. But now companies are required to disclose every ingredient in the ingredient list of cosmetic products. Irritants that may be present in perfumes include limonene, linalool, and citral.

As a result, consumers can make informed decisions about which products are best for themselves and their families. Everyone has the right to know what’s in their products.

Compliance with MoCRA can be time-consuming and resource-intensive, impacting your business operations. However, don’t let MoCRA cause you worry! GOL Service for MoCRA Compliance is designed to help you address all compliance-related issues. GOL’s service will assist your business in:

  • Saving time and money: Our intelligent automation system helps you automate MoCRA tasks, saving time and costs for your business.
  • Minimizing risks: GOL’s experienced team of experts will guide you in complying with MoCRA accurately, avoiding errors and legal risks.
  • Avoiding penalties: GOL’s service ensures your full compliance with MoCRA regulations, avoiding hefty fines from the FDA.

Contact GOL today for a free consultation on GOL Service for MoCRA Compliance!

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