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
Category: FDA Compliance
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 One-Day Inspectional Assessments: What FDA-Regulated Companies Need to Know in 2026
The U.S. Food and Drug Administration (FDA) has officially launched a new inspection initiative known as One-Day Inspectional Assessments (ODIAs), signaling an important shift in how FDA-regulated companies may be inspected moving into 2026 and beyond. For manufacturers, exporters, and FDA-regulated businesses supplying products to the United States, this development reflects the FDA’s growing focus… Continue reading FDA One-Day Inspectional Assessments: What FDA-Regulated Companies Need to Know in 2026
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
Role of a US FDA Agent in Food Facility Registration: How Fiducia Globus Supports Food Importers into the USA
For companies importing food into the United States, regulatory compliance with the US Food and Drug Administration is mandatory. Under the Food Safety Modernization Act, all foreign facilities that manufacture, process, pack, or hold food for US consumption must complete FDA Food Facility Registration before shipping products to the US market. One of the most… Continue reading Role of a US FDA Agent in Food Facility Registration: How Fiducia Globus Supports Food Importers into the USA