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How FDA's New Cosmetic Regulations Impact Cosmetic Safety

Written by Registrar Corp

MoCRA will introduce a host of new obligations that cosmetics firms must adhere to in order to sell their products in the U.S. The Act's goal to boost transparency, reinforce compliance, and advocate for cosmetic safety will most notably affect record-keeping requirements.

These regulations form part of a wider regulatory shift that encompasses inspections, Good Manufacturing Practices (GMPs), sufficient safety validation, and reporting of adverse events. Regular record-keeping is vital for record accessibility, which will be necessary during inspections and to show GMP adherence.

If you are not familiar with what MoCRA involves, it's crucial to inform yourself now and start readying your products for the new FDA requirements going into affect as early as December 29, 2023 and beyond. 

GMPs & Inspections: Key Cosmetic Safety Factors

MoCRA legislation requires the Food and Drug Administration to establish Good Manufacturing Practices (GMPs) that are intended to protect the public's health, ensure that cosmetics safety is intact, and products are not adulterated.

The regulations will allow FDA to inspect facilities and review all records it deems necessary to verify GMP compliance as defined by FDA. Products will be deemed adulterated if they do not adhere to GMP requirements.  

The FDA defines a two-year timeframe for FDA to release a Notice of Proposed Rule-making for Cosmetic GMPs. Furthermore, the agency is required to issue a Final Rule within three years following the enactment. 

Adequate Safety Substantiation 

Under MoCRA, cosmetic companies must maintain records supporting adequate cosmetic safety substantiation for their products.  
The new regulations define substantiation as “tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.” 

MoCRA mandates that the Responsible Person whose name is displayed on the label of a cosmetic product must keep documents proving that the product has "adequate safety substantiation". A product will be deemed adulterated if this requirement is not met.  

The act also grants FDA authority to issue a mandatory recall if the use of, or exposure to, an adulterated cosmetic will cause serious adverse health consequences or death. 

Adverse Events

Cosmetic companies are also now required to maintain records of, and report, adverse events. FDA requires these records to be available should any of your products pose a potential threat to public health. Upon identification of a threat, FDA now reserves the right to enforce detentions, refusals, and mandatory recalls of these products.  
Cosmetic serious adverse event reporting must be conducted and submitted to FDA within 15 business days — including any updates that follow within a year of the original submission.  
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.  
Section 605 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 

Records of adverse event reports must be maintained for 6 years, and FDA must be able to access them during inspections.   

If considered a small business, the responsible person is required to maintain records for no less than 3 years. The FDA categorizes small businesses as those whose average annual gross sales have not exceeded $1,000,000 over the past three years for cosmetic products marketed in the U.S. 

If the FDA suspects that an ingredient or a mix of ingredients in the product's fragrances or flavors has led to severe adverse events, it may ask for a written list of all the ingredients. This list must be submitted within 30 days of FDA’s request.

Record Keeping Solutions

Because substantial records must be maintained for each cosmetic, obtaining a specialized system and learning how to use it is crucial to keeping records organized and easily accessible if FDA requests them.  

Cosmetri PM & GMP include record-keeping features that make it easy for companies to track their GMP documentation. This industry leading software enables your teams to collaborate quickly and easily on the development of safe and compliant cosmetic products. 
Through a user-friendly interface, cosmetic professionals can manage innovative projects more quickly and with less human error than ever before. Cosmetri even allows for efficient and effective management of your raw material inventory, manufacturing orders, and packaging in a secure and centralized location.  
Manufacturers and cosmetics industry experts can ensure compliance with all traceability requirements in the locations where the products are manufactured and distributed. 
Cosmetri is crafted to boost innovation, reduce time-to-market, and simplify cosmetic compliance. It uses a 30,000+ ingredient database, a regulatory check functionality, a project and document management feature, and more...  
When employing a comprehensive digital platform like Cosmetri for document management, cosmetics professionals can feel confident knowing that their work is producing effective and safe products for consumers around the world. 

About the Author

Since 2003, Registrar Corp has been the global leader in FDA compliance, serving over 30,000 companies each year in over 190 countries with tech-enabled compliance services, online compliance training, and supply chain software. Headquartered in Hampton, Virginia, Registrar Corp has 19 worldwide offices actively helping businesses understand the complexities of U.S. FDA regulations.


Content provided by Registrar Corp. References are provided for informational purposes only. The information is the opinion of the author and its appearance in this blog is not considered an endorsement by the SCC. SCC makes no representation, express or implied, regarding the accuracy, adequacy, validity, reliability, availability or completeness of any information contained therein.