Many cosmetic brands unintentionally create regulatory risk by using marketing claims that may cause the U.S. Food and Drug Administration (FDA) to classify their products as drugs rather than cosmetics. While product formulations are important, FDA often evaluates intended use based on labeling, website content, advertisements, social media posts, testimonials, and other marketing materials. A… Continue reading Cosmetic Claims That Can Trigger FDA Drug Classification: A Compliance Guide for Cosmetic Brands
Tag: FDA Cosmetics
MoCRA Serious Adverse Event Reporting: A Complete Compliance Guide for Cosmetic Brands Selling in the United States
A single customer complaint can become a regulatory issue much faster than many cosmetic brands realize. Under the Modernization of Cosmetics Regulation Act (MoCRA), companies marketing cosmetic products in the United States must carefully evaluate complaints and determine whether they qualify as serious adverse events requiring FDA reporting. For cosmetic manufacturers, private label brands, importers,… Continue reading MoCRA Serious Adverse Event Reporting: A Complete Compliance Guide for Cosmetic Brands Selling in the United States
FDA vs Health Canada Cosmetic Regulations: A Technical Comparison of Compliance Requirements for Cosmetic Products
Companies planning to commercialize cosmetic products in North America frequently target both the United States and Canada due to their large consumer markets and strong distribution networks. Although these markets are geographically close, cosmetic regulatory frameworks in the United States and Canada differ significantly in terms of ingredient restrictions, labeling requirements, facility obligations, and regulatory… Continue reading FDA vs Health Canada Cosmetic Regulations: A Technical Comparison of Compliance Requirements for Cosmetic Products