U.S. FDA (Food and Drug Administration) regulates all cosmetic products that are intended to be sold and used in the US. In addition, the state of California has imposed additional requirements for cosmetic products intended for sale in California. ALN provides assistance for both United States-based and non-US-based companies with FDA registration who wish to sell cosmetics products in the United States and the state of California.
“From Ingredient Statement filings to Labeling Assistance, we help U.S. and Non-U.S. companies in the Cosmetic Products Industry.”
FDA Cosmetic Labeling & Ingredient Reviews
The FDA has strict laws regarding both the ingredients and labeling of cosmetic products with Labeling errors being one of the leading causes of FDA detentions. We can assist you with your cosmetic labeling and ingredient compliance by providing a detailed report which cross references your labeling against the Code of Federal Regulations, VCRP Cosmetics Dictionary and other FDA guidance documents.
FDA Cosmetic Color Additive / Color Batch Certification
In the U.S., all color additives—including dyes, pigments, or any other substances that add color to a cosmetic product—are subject to regulation by the U.S. FDA. Our team can prepare reports on the specific requirements, lend guidance on protocol, and help you file for certification to help the process go more quickly and smoothly.
FDA Cosmetic Product Registration and Reporting
ALN assists companies with reporting required by the California Safe Cosmetics Program as well as filings of Cosmetic Product Ingredient Statements (CPIS) and registrations of cosmetic product establishments through the FDA Voluntary Cosmetic Registration Program (VCRP)
Companies shipping products to the United States may find their shipments to be non compliant and subject to detention by FDA at the US port of entry (DWPE) Detention Without Physical Examination. We will work with you to solve the problem so the product can move past the Port of Entry and delivered to the intended final consignee.