When buyers search for "FDA certified eyeliner" on Alibaba.com, there's often confusion about what this actually means. Unlike drugs or medical devices, cosmetics do not require FDA pre-market approval (with one important exception: color additives). This is a critical distinction that many suppliers misunderstand.
The FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). However, the regulatory landscape changed dramatically with the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, which represents the most significant expansion of FDA's cosmetics authority since 1938 [1].
Under MoCRA, cosmetics manufacturers and processors must now comply with several new requirements:
• Facility Registration: All facilities manufacturing or processing cosmetics must register with FDA every 2 years • Product Listing: All cosmetic products must be listed with FDA annually, including ingredient information • Safety Substantiation: Manufacturers must maintain records demonstrating adequate safety substantiation for each product • Adverse Event Reporting: Serious adverse events must be reported to FDA within 15 business days • Labeling Requirements: Labels must include contact information for adverse event reporting [2][3]
For eyeliner specifically, there is no small business exemption. While MoCRA provides exemptions for businesses with less than $1 million in average annual sales over the previous 3 years, this exemption does NOT apply to eye cosmetics due to their higher risk profile [3].
"Look into FDA cosmetic labeling requirements. You need ingredient labels and basic compliance before scaling." [5]
