FDA OTC Sunscreen Compliance: A Complete Guide for U.S. Market Registration Introduction Sunscreens are considered Over-the-Counter (OTC) drug products in the United States and are subject to strict regulatory oversight by the U.S. Food and Drug Administration (FDA). If you’re a cosmetic brand, private labeler, or manufacturer looking to sell sunscreen products in the U.S., […]
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How U.S. Tariffs Affect Imports of FDA-Regulated Products: What Importers Need to Know Introduction Importing FDA-regulated products into the U.S. involves more than just regulatory compliance. Rising U.S. tariffs on specific goods can significantly affect your business strategy, especially if you’re importing cosmetics, dietary supplements, food, or medical devices. This article explores how tariffs and
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How to Import Cosmetics into Canada: A Step-by-Step Guide for Global Brands If you’re looking to expand your cosmetic brand, learning how to import cosmetics into Canada is a critical first step. The Canadian market offers incredible potential for growth, but it’s also governed by strict regulations. From labeling laws and ingredient restrictions to product
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Québec’s Bill 96 introduces strict French-language requirements for cosmetic brands selling in the province. From product labels to websites and customer service, brands must ensure French is clearly and equally displayed across all consumer touchpoints. This includes translating ingredient lists, marketing claims, and even parts of registered trademarks by 2025. Failure to comply can lead to fines, product removal, or reputational damage. In this guide, we explain how Bill 96 affects cosmetics, what changes are mandatory, and what steps brands must take to remain compliant in the Québec market.
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When selling cosmetic products in the European Union, understanding the difference between shelf life and Period After Opening (PAO) is crucial for regulatory compliance. This article explains these two concepts as defined by EU Cosmetic Regulation (EC) No 1223/2009, including when to use each, what documentation is required, and how to remain compliant.
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The EU introduces Omnibus Act VII, banning new CMR substances in cosmetics effective September 1, 2025. Learn what ingredients are affected and how to stay compliant.
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Navigating Amazon Dietary Supplements Requirements: A 2025 Compliance Guide Selling dietary supplements on Amazon USA can be highly profitable, but it also involves strict compliance with both Amazon’s internal policies and U.S. federal regulations. In recent years, Amazon has significantly tightened its oversight on supplement listings, making it critical for sellers—both domestic and international—to understand
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Understanding DSHEA: The Framework for Dietary Supplement Regulation in the U.S. What is DSHEA? The Dietary Supplement Health and Education Act (DSHEA) of 1994 is a U.S. federal law that defines and regulates dietary supplements. Passed as an amendment to the Federal Food, Drug, and Cosmetic Act, DSHEA established a distinct regulatory framework for dietary
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FDA Cosmetic Registration: MoCRA Product Listing Requirements Understanding FDA Cosmetic Registration and MoCRA Obligations FDA cosmetic registration is now a requirement under the Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022. This regulation introduces mandatory listing obligations for all cosmetic products marketed in the United States. Every cosmetic item must be
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FDA Proposes Mandatory Asbestos Testing for Talc-Based Cosmetics: What It Means for Industry Compliance Overview On March 25, 2025, the U.S. Food and Drug Administration (FDA) proposed a long-anticipated rule requiring mandatory, standardized testing for asbestos in talc-based cosmetic products. This move is a direct response to consumer safety concerns and past reports of asbestos
