In the highly regulated U.S. cosmetics market, even established brands may face situations where products must be withdrawn due to safety concerns, misbranding, or contamination. Under the Modernization of Cosmetics…
Correctly determining whether a product is regulated as a cosmetic, drug, or OTC hybrid is one of the most critical steps for companies entering the U.S. market. Misclassification can lead…
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marks the most significant update to U.S. cosmetic regulations since 1938. Enacted by the FDA, MoCRA introduces new mandatory requirements for…
Accurate and compliant labeling is one of the most important requirements for cosmetic products marketed in the United States. The FDA enforces 21 CFR Part 701 – Cosmetic Labeling Regulations,…
Cosmetic manufacturers, packers, and distributors selling products in the United States must be prepared for FDA inspections and audits. With the implementation of the Modernization of Cosmetics Regulation Act (MoCRA),…
For cosmetic and personal care products marketed in the United States, ingredient compliance and safety are top priorities. The FDA requires that all ingredients used in cosmetics must be safe…
Successfully importing food, beverages, dietary supplements, cosmetics, and OTC products into the U.S. requires strict adherence to FDA import compliance and U.S. Customs clearance regulations. Failure to meet these requirements…
Maintaining Good Manufacturing Practices (GMP) is essential for cosmetic companies that want to ensure product quality, safety, and regulatory compliance in the U.S. While the FDA does not require cosmetics…
Ensuring consumer safety is at the core of FDA regulations, and one of the most critical obligations for companies in the food, dietary supplement, cosmetic, and OTC product industries is…
The National Drug Code (NDC) is a unique identifier for medicines in the United States, assigned by the U.S. Food and Drug Administration (FDA). Click here to obtain an NDC…