If it’s Not in Writing, it Doesn’t Exist!

You’ve likely heard the term before in business and with FDA – if it’s not in writing, it doesn’t exist. But what is all the kerfuffle about with records under MoCRA, and why do cosmetic businesses really need to now make recordkeeping a priority?

Well for starters, it is required under the law! The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements for cosmetic businesses to develop and maintain records as follows:

• Adverse Event Reporting and record retention of adverse events (AE) records and serious adverse events (SAE). Information includes patient/product or ingredient’s name, type of reaction, classification (AE vs. SAE) and more. Records must be maintained for 6 years (3 for small businesses).
  
  
• GMP compliance and recordkeeping (current GMP standards are provided in existing federal and international standards (see prior post here), with FDA’s final rule anticipated in the next 1-2 years).
  
  
• Fragrance Allergen disclosures and recordkeeping: each fragrance allergen included in a cosmetic product must be disclosed (proposed rule anticipated by June 2024). Businesses should develop and maintain records of ingredient lists and fragrance allergens. If FDA has reasonable grounds to believe a fragrance or flavor contributed to a SAE, subject to reporting requirements, FDA also has the ability to request a list of such ingredients or categories of ingredients in writing.
  
  
• Records of site registration and product listing unless a small business (less than $1M for preceding 3 years); we recommend a letter be kept on file supporting exemption, as applicable.
  
  
• Safety Substantiation: businesses are required to maintain records substantiating safety, including for fragrances. This includes clinical testing, literature, and supplier information to support safety. See prior post here for more information on cosmetic product substantiation.
  
  
• Labeling, product formulation and product specification records
  
  
• Polyfluoroalkyl substances (PFAS) will have reporting requirements
  
  
• Talc Asbestos Records: FDA will establish and require standardized testing methods for detecting asbestos in talc-containing products, and therefore recordkeeping requirements to demonstrate that testing supports compliance.

As we discussed in our prior News & Insights article here, MoCRA provides FDA new inspection authorities and related required for the Responsible Person (RP), which is defined as the manufacturer, packer or distributor of a cosmetic product whose name appears on the product label. This includes FDA’s ability to request the above required records, as applicable, during a routine cosmetic inspection, and/or a for-cause inspection.

We recommend getting basic records in order now, as getting MoCRA and GMP compliant is a long-game. U.S. regulatory compliance is also not only mandated by governing bodies, but also critically, by big box retailers, other businesses, and consumers.

Ultimately, developing a system and culture of compliance, and strong recordkeeping and retention leads to better product, happy customers, and a strong FDA compliance record (pun intended!).

For more information on your cosmetic compliance obligations and considerations, please contact us at info@garg-law.com.