US Cosmetic Regulatory Requirements for Manufacturers (MoCRA)

US Cosmetic Regulatory Requirements for Manufacturers (MoCRA)

FDA cosmetic regulations


Behold the “Modernization of Cosmetic Regulation Act of 2022” that President Biden signed on December 29th 2022.  This law requires an increased FDA oversight of cosmetics and their ingredients. In this article we’ll discuss the key provisions, timelines for enforcement actions, new requirements and summarize the regulatory implementation mentioned in this Act.  This new U.S law includes amendments to FDA requirements around improvements in drug manufacturing and reauthorization of key FDA programs.  We wouldn’t be surprised in Amazon started to take a more proactive approach to this law even with a 3-year timeline before MoCRA goes into full effect.

What is the Modernization of Cosmetic Regulation Act of 2022 (MoCRA):

MoCRA will establish a process that to ensure cosmetic manufacturers provide assurances that their products are safe for consumer use.  The law put together responsibilities for the “responsible person” who is the packer, creator, or distributor of the cosmetic whose name appears on the cosmetic label.  MoCRA applies to importers and entities who manufacture or process cosmetics.

It does not apply to the following entities if they do not import, manufacturer, or process cosmetics: beauty salons; cosmetic product retailers; distribution facilities; pharmacies; hospitals; physicians’ offices; health care clinics; public health agencies and other nonprofit entities; entities that provide complimentary cosmetic products; trade shows and others giving free samples; entities that are only doing research; and entities that prepare labels, relabel, package, repackage, hold, and/or distribute cosmetic products.

Good Manufacturing Practices: The secretary of the Department of Health and Human Services (HHS) (through the FDA) will propose and finalize regulations to establish good manufacturing practices. The key is to ensure that products are not adulterated and will allow FDA to inspect records to ensure compliance. The proposed rulemaking shall be no later than two years after date of enactment (December 29, 2022) with final regulations no later than three years after date of enactment (December 29, 2022).

Process for Reporting Adverse Events: In compliance with the HHS secretary’s regulations, the responsible person shall file a report within 15 days and may supplement the report within one year. A serious adverse event report is similar to other safety reports and can include a statement released to the public (without any personal health information). The HHS secretary may exempt certain reports that do not involve a significant public health issue. Records must be kept by the responsible person for six years; three years for small businesses. There is a Rule of Construction that the submission of any report shall not be construed as an admission that the cosmetic product involved, caused, or contributed to the relevant adverse event.

Need help navigating the FDA MOCRA cosmetic regulations?

MoCRA Registration and Product Listing:

Cosmetic manufacturers must submit a registration no later than ONE YEAR AFTER ENACTMENT (December 29, 2022). New facilities must register within 60 days (or 60 days after deadline). Renewal is every two years. Updates or changes must be submitted within 60 days of the change.  The company registering their cosmetic products must list everything they import manufacture or process and include product categories, list of ingredients and product listing number. 

Flexibility may be given to the listing of multiple products with identical formulations colors, fragrances, quantity, or flavors.  FDA will not share confidential information included in a listing when a request for info is filed.

Cosmetic Entity Registration:

The HHS secretary may suspend registration if there is a potential for the product to cause serious negative health effects or deaths.  The HHS secretary will send a notice of suspension if health concerns arise after the manufacturing of the health products and may conclude that:

  1. the suspension remains necessary or
  2. the registrant must submit a corrective action plan to demonstrate remediation of the problem conditions. 

Within 14 business days the plan will be reviewed and is the secretary vacates the suspension FDA will restart the registration.  If the cosmetic manufacturing facility is suspended nobody will be allowed to introduce or deliver cosmetic products from the suspended facility.

Records: Records must be made available to authorised personnel for product examination if there is reason to believe a cosmetic product is adulterated or an ingredient may cause harm or violate other standards. Authorized personnel must provide written notice to gain access to records in a reasonable amount of time in order to determine whether the product poses a threat. Recipes or formulas for cosmetics, financial data, pricing data, personnel data (except qualifications), research data (other than safety substantiation), or sales data are not among the records to be reviewed (other than shipment data regarding sales).

Cosmetics containing PFAS: The HHS secretary must evaluate the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products, as well as the scientific evidence regarding cosmetic product safety, including risks. The Secretary of Health and Human Services may consult with the National Center for Toxicological Research. A report summarising the results of the assessment must be issued no later than three years after enactment.

The Congress’s position on animal testing is that it should not be used for the purposes of safety testing on cosmetic products and should be phased out except for appropriate allowances.

How Quality Smart Solutions can help

Need help ensuring your cosmetic ingredients are safe for use? Get assistance with your U.S cosmetic product compliance from our consultants. Contact Quality Smart Solutions today! We can help.

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