MoCRA (Modernization of Cosmetics Regulatory Act)

MoCRA

What is MoCRA?

MoCRA stands for Modernization of Cosmetic Regulation Act, and represents the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.

This is a substantial change, as it introduces obligations for manufacturers and strengthens the FDA’s power to intervene.

What updates has MoCRA introduced?

As of December 29, 2023, the MoCRA has been enacted, bringing forth notable innovations concerning cosmetic products in the US market. These include:

  • The identification of a US Responsible Person, who must be indicated on the label and must be in contact with the FDA;
  • More powers to FDA;
  • Manufacturers and processors must register their facilities with the FDA and renew their registration every two years. The FDA has the authority to suspend a facility’s registration if it determines that a cosmetic product manufactured or processed by the registered facility and distributed in the United States has a reasonable likelihood of causing serious adverse health consequences or death to humans;
  • The production of cosmetics must take place in factories that apply GMP. A new regulation regarding GMP must be promulgated by 29 December 2025;
  • Every cosmetic product must be labeled with the list of ingredients, including “allergens”;
  • Businesses and entrepreneurs involved in creating or promoting cosmetics bear the duty to guarantee their offerings are safe for consumer use. While neither legislation nor FDA guidelines mandate explicit testing to confirm the safety of particular items or components, it is imperative for a designated responsible party to verify and keep documentation that validates the sufficient safety substantiation of their cosmetic goods. Producers have the option to utilize existing relevant safety information to back the safety claims of their products. It’s not obligatory to conduct animal testing to market a cosmetic item. Nonetheless, it’s crucial that any data employed to underpin the safety claims is obtained through scientifically sound methodologies.

The FDA’s expanded authorities now grant them privileged access to specific documents related to cosmetic products, encompassing safety records. Additionally, they possess the authority to withdraw cosmetic products deemed unsafe from the market.

Obligations of the chosen responsible person:

  • The responsible person is required to report any adverse events encountered to the FDA. A contact address must be provided on the label that allows consumers to report any adverse effects;
  • The responsible person must list each marketed cosmetic product with the FDA, including the product’s ingredients, and provide any updates annually;
  • The responsible person is required to secure and maintain documentation to support adequate evidence of the safety of their cosmetic products. Manufacturers can use already available safety data to support the safety of their products. Animal testing is not a requirement for the marketing of a cosmetic product. It is important, however, that all data used to support safety comes from scientifically sound methods.

Safety substantiation:

Cosmetic products must be safe for consumer use as directed on their labels or as commonly expected.

As for the safety assessment, manufacturers have the option to utilize existing safety data for individual ingredients and products with similar formulations, including information from cosmetic ingredient suppliers, scientific journals (e.g., PubMed, TOXNET), and the Cosmetic Ingredient Review (CIR) website. The CIR, an industry-funded panel, reviews the safety of cosmetic ingredients, and while the FDA participates in these meetings without voting rights, it considers CIR reviews in its safety evaluations.

In addition to existing data, manufacturers may need to conduct toxicological tests to address any information gaps, ensuring the safety of ingredients and the final product. Animal testing is not mandatory for cosmetics, but all tests must be scientifically valid. The FDA doesn’t refer private testing labs but suggests consulting resources under “Trade and Professional Associations of the Cosmetics Industry” for assistance.

Cosmetics aren’t required to be sterile but shouldn’t contain harmful microorganisms, with strict limits on aerobic microorganisms. Manufacturers are advised to use microbiological methods to prevent contamination and may need to consult with experts if they lack the technical knowledge to ensure product safety.

Excemptions:

MoCRA exempts certain small businesses from GMP, registration, and product listing requirements.

“Small Businesses” as defined in Section 612 of the FD&C Ac: responsible persons, owners and operators of establishments, whose average annual gross sales of cosmetic products in the United States for the preceding three-year period are less than $1.000.000, adjusted for inflation.

These exemptions do not apply for:

  • Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use;
  • Products that are injected;
  • Products that are intended for internal use;
  • Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.

 

To conclude, MoCRA represents a major change to US cosmetics regulation by giving more power to the FDA and greater responsibilities for cosmetics manufacturers, significantly changing how companies approach the US market.

ToxHub’s team of experts (one of whom is a Qualified Cosmetic Safety Assessor) can assist you with MoCRA compliance activities, helping your company successfully market your cosmetic products in the United States. Do not hesitate to contact us for any inquiry!
Article issued by Maria Labianca
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