While MoCRA provides a small company exemption from FDA Product Registration, all companies regardless of size, must maintain on file a Safety Substantiation Dossier documenting that their products are safe for human use. This is the most significant new requirement in MoCRA affecting Indie Beauty Brands.

Here’s the language from the FDA MoCRA Draft Guidance For Industry

“Safety Substantiation: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.”

“A Responsible Person (ie: the Brand) is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products. Manufacturers (Brands) can use relevant safety data that is already available to support the safety of their products. Animal testing is not a requirement for marketing a cosmetic product. It’s important, however, that all data used to support the safety are derived from scientifically robust methods.”

The FDA is somewhat vague in its requirements to establish Safety Substantiation, but clearly states that neither MoCRA nor the FDA require specific tests to establish Safety Substantiation.

So, what exactly is Safety Substantiation?

Here’s some guidance for Indie Beauty Brands:

(1). Preservative Challenge Testing: Conduct either static Preservative Challenge Tests or In-Use PCT on all of your products

(2). Conduct 48 Hour Patch Testing or HRIPT (Human Repeat Insult Patch Test) on all of your products. If you want to distribute through third-party online channels such as Amazon, you will need to conduct HRIPT

(3). Commission an Ingredient Toxicology Safety Assessment Report on the ingredients in each product. If you plan on selling in the EU you will need to commission an EU Safety Assessment compiled by a qualified EU Safety Assessor.

With these records in hand, you will be able to provide a Safety Substantiation Dossier should the FDA request to see your records.