February 07, 2025
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has ushered in a new era of regulatory oversight for the cosmetic industry. With the FDA now actively enforcing these new rules, cosmetic businesses must ensure compliance—or face the consequences. Recent warning letters issued by the FDA highlight the growing scrutiny under MoCRA, emphasizing the urgent need for businesses to understand and implement the necessary regulations.
MoCRA Enforcement Is Here: What You Need to Know
The FDA has begun issuing warning letters to companies that fail to meet MoCRA’s regulatory requirements. Some of the most common violations include:
Failure to Comply with Good Manufacturing Practices (GMPs):
The FDA now mandates GMP compliance for cosmetic manufacturers to ensure product safety and quality.
Some companies have been cited for inadequate ingredient testing, improper sanitation procedures, and lack of quality control measures.
Unreported Adverse Events:
MoCRA requires companies to report serious adverse events associated with their products within 15 business days.
Some firms have already been warned for not maintaining proper records of customer complaints and failing to report safety concerns.
Lack of Facility Registration and Product Listing:
Under MoCRA, all manufacturing facilities must register with the FDA, and every cosmetic product must be listed.
Non-compliant companies have faced regulatory scrutiny for operating without proper registration.
Misleading or Unsubstantiated Claims:
The FDA has flagged cosmetic companies for making drug-like claims about their products, such as anti-aging, acne treatment, or skin healing benefits, without appropriate approvals.
Recent FDA Warning Letters: Who’s Been Caught?
While MoCRA is still in its early enforcement stages, several companies have already faced FDA action. Some notable examples include:
Little Moon Essentials, LLC (USA) – Cited for GMP violations and unapproved drug claims related to cosmetic products.
Multaler et Cie SAS (France) – Flagged for non-compliance with MoCRA regulations and failure to maintain proper safety documentation.
Landy International (China) – Issued a warning due to concerns over ingredient safety and product contamination risks.
These warning letters serve as a wake-up call for the entire cosmetic industry. The FDA is serious about enforcement, and companies that fail to comply risk product recall, import bans, and even legal action.
How Provision Consulting Group Can Help
Navigating MoCRA’s complex regulations can be overwhelming, but you don’t have to do it alone. Provision Consulting Group offers expert guidance to ensure your company meets all MoCRA requirements, including:
GMP Compliance Audits – Assess your manufacturing processes to identify and correct compliance gaps.
Adverse Event Reporting Systems – Implement tracking and reporting protocols to ensure regulatory adherence.
FDA Facility Registration & Product Listing – Get your business registered and ensure every product meets the required standards.
Labeling & Marketing Compliance – Avoid FDA warnings by ensuring your claims align with regulatory guidelines.
Take Action Before It’s Too Late
MoCRA compliance is no longer optional—it’s a legal requirement. With the FDA cracking down on non-compliant businesses, now is the time to ensure your company is fully prepared.
Provision Consulting Group is here to help you stay ahead of the regulations and keep your business safe from FDA enforcement actions. Contact us today to schedule a compliance consultation and safeguard your cosmetic brand’s future!
Don’t wait for a warning letter—take proactive steps to secure your business today.
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