The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is set to bring significant changes to the U.S. cosmetics industry.
MoCRA will establish a myriad of new requirements cosmetics companies will need to comply with to market their products in the U.S. Record-keeping requirements will be significantly impacted as a result of MoCRA's aim to increase transparency, strengthen compliance, and promote cosmetic safety.
The requirements are a component of a broader regulatory transition that includes inspections, GMPs, adequate safety substantiation, and adverse event reporting. Consistent record-keeping is critical for record access, which will be required during inspections and to demonstrate GMP compliance.
If you are unaware of what MoCRA entails, now is the time to educate yourself and begin preparing your products for upcoming requirements.
Inspections and GMPs
MoCRA requires FDA to establish Good Manufacturing Practices (GMPs) that are intended to protect the public's health and ensure that cosmetics 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.
FDA has 2 years from MoCRA’s enactment to publish a Notice of Proposed Rulemaking for the Cosmetic GMP, and the agency must issue a Final Rule no later than 3 years after enactment.
Adequate Safety Substantiation
Under MoCRA, cosmetics companies must maintain records supporting adequate cosmetic safety substantiation for their products.
The legislation defines 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 requires the person whose name appears on a cosmetic product’s label to maintain records establishing that there is “an adequate substantiation of safety” for the product. A product will be deemed adulterated if this requirement is not met.
The act 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.
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 3 years. FDA defines small businesses as those with average gross annual sales of cosmetic products in the U.S. totaling less than $1,000,000 for the previous three-year period.
FDA may request a written list of all ingredients in the product’s fragrances or flavors if it believes an ingredient or combination of ingredients has caused serious adverse events. This list must be submitted within 30 days of FDA’s request.
Solutions for Record Keeping
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 GMP includes record-keeping features that make it easy for companies to track their GMP documentation.
With Cosmetri GMP, companies access full electronic document management for GMP compliance. Users can also report an out-of-specification for any product formula, raw material, or manufactured product batch, and manage key performance indicators to drive continuous improvement.
To avoid becoming overwhelmed with paperwork, companies should prepare now for MoCRA’s record-keeping requirements. Facilities can plan ahead of the requirements by gathering records and using a comprehensive digital system to manage documentation.
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