New FDA Guidelines: A Major Shift in Cosmetics Safety
The U.S. Food and Drug Administration (FDA) has recently issued an extensive update to the guidance on cosmetic product facility registration and listing requirements. This comes under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The updated guidance, which was published in October 2024, includes crucial safety measures for tattoo inks and expanded requirements for cosmetic manufacturers.
Addressing Safety Concerns in the Beauty Industry
The FDA’s October 2024 guidance, titled “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination”, addresses the growing safety concerns in the beauty industry.
This guidance provides manufacturers with detailed requirements for preventing microbial contamination in tattoo ink preparation, a significant public health concern.
Additional Updates in the Guidance
Additionally, the FDA has finalized a list of frequently asked questions about facility registration requirements. This includes:
- New provisions for U.S. agents of foreign manufacturers
- Guidelines for free sample product listings
The agency has also expanded the definition of eye-area products that disqualify companies from small business exemptions. This now includes eye shadow products that are “intended to be applied in the proximity of the eye.”
A Significant Update in Cosmetics Safety
These regulatory changes represent the most significant cosmetics safety updates since 1938. Full compliance is required by manufacturers to continue distributing products in the United States.