Experien Health Sciences understands that the cosmetic and personal care products industry is highly competitive and relies heavily on marketing and branding. But gone are the days when only the big brands could afford the cost of advertising and maintaining enough inventory to keep brick-and-mortar shelves full.

Consumers are shifting away from the big brand products towards new direct-to-consumer brands marketed by savvy social media influencers. This shift has raised concerns among regulators around the world about product safety and, as a result, they have begun to impose new requirements on the industry. In 2022, the U.S. Food and Drug Administration (FDA) passed the Modernization of Cosmetics Regulation Act (MoCRA) resulting in the most significant expansion of FDA’s authority to regulate cosmetic and personal care products since 1938. For the big brands who have long understood that product recalls are bad for business, MoCRA imposes a level playing field on the entire industry, excluding small businesses with < $1M in annual sales and no manufacturing or processing facilities, and is forcing smaller brands to step-up their product safety assurance game. It’s no longer just about keeping adulterated and misbranded products out of the hands of consumers, but now is about having robust and verifiable systems in place to convince regulators that consumers are being protected.

While MoCRA has been structured in a way that still gives companies a great deal of flexibility in how to demonstrate compliance, regulators will ultimately look for sophisticated and well-documented systems like those of the bigger brands. That’s where we come in. We know what is expected and can help put the following systems in place, as required by MoCRA, or audit what you already have to identify areas for improvement:

  • Serious Adverse Event Reporting.
  • Current Good Manufacturing Practices (cGMP), including audits of suppliers and contract manufacturers.
  • FDA Facility Registration, Product Listing, & Ingredient Reporting.
  • Safety Substantiation and Toxicological Risk Assessment (TRA).
  • Product Testing and Keeping PFAS out of Cosmetics.
  • Product Recall Procedures.
  • Access to Records and Documentation.
  • Product Labeling Compliance and Review of Marketing Claims.
  • Fragrance Allergen Disclosures.


Learn more about how Experien Health Sciences can help you.