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INSIGHTS

August 9, 2023

Can’t Conceal This!

What You Need to Have in Place Now for MoCRA Cosmetic Product Substantiation

While FDA cosmetic product safety has always been required, MoCRA ups the ante and ensures that companies can no longer hide behind cover-up. As we discussed in our June 26 News and Insights issue, “Prep + Prime for MoCRA”, MoCRA’s new safety substantiation requirement provides that responsible persons are required to ensure and maintain records supporting adequate product safety substantiation of cosmetic products by December 29, 2023. This requires Responsible Persons to show a cosmetic product is safe to be marketed in the U.S. and meets established safety standards to avoid being considered adulterated (prohibited U.S. entry or sale).

To be clear, this applies to all cosmetics products, and should be in place before December 29, 2023.

Although neither MoCRA nor the FDA prescribe required tests, the optimal way for businesses to establish product safety is to have a certified Safety Assessment. As several other countries require this to place a product on the market, having a complete product information file as required by the EU or UK is likely to provide adequate safety substantiation.

Short of a Safety Assessment, a cosmetics business may use the following sources in combination, as appropriate, to help substantiate safety:

  • CIR reports (as long as you are in the “safe as used” category with recommended use levels
  • EU Scientific Committee on Consumer Safety (SCCS Opinions)
  • Raw Material Specifications, SDS and Safety Test Data
  • We recommend having consumer in use tests to support claims, with information concerning any physiological reactions to the product
  • HRIPT Sensitization (recommend 100 or 200-member panel)
  • Products should have some indication of microbiological acceptability-either preservation testing or if nonaqueous, a water activity test is recommended. All aqueous products should be subject to microbiological activity testing as a product release requirement.

Businesses must readily have this information available and have the information stored in an organized way, not just on file. Additionally, the Responsible Person is responsible for reviewing the data, maintaining it, and acting if there is questionable information.

We recommend putting these Safety Assessment together and maintaining records now by adopting the following approach:

  • Conducting a GAP analysis of your records for each of your cosmetic products/SKUs and identify what you need
  • Arrange and conduct testing: If testing is required, it can take 6-8 weeks or more to complete. Identify and work with testing labs to have this in place in a timely manner
  • Receive and assess results
  • Develop recordkeeping system
  • Maintain records

So don’t hide under concealer – prepare now and have cosmetic product substantiation in place before December 29, 2023.

 

For more information on MoCRA and cosmetic product safety substantiation, please contact us at info@garg-law.com. 

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Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
R.G. Client
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Mike H. Client
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
Dr. Sastry Client
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
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