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For foreign cosmetic companies seeking access to the U.S. market, appointing a U.S. Agent is not optional it is a mandatory requirement under FDA regulations. Any cosmetic facility located outside the United States that manufactures, packages, or processes cosmetic products for distribution in the U.S. must designate a U.S. Agent. [...]
In the highly regulated U.S. cosmetics market, even established brands may face situations where products must be withdrawn due to safety concerns, misbranding, or contamination.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 Regulation Act (MoCRA), the FDA now has stronger authority to oversee recalls and enforce corrective actions. This makes it critical [...]
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 to FDA enforcement actions, product recalls, detentions at ports, and costly re-labeling or reformulation. The U.S. FDA defines cosmetics as [...]
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 cosmetic manufacturers, packers, and distributors selling products in the United States. Compliance is no longer optional companies must adapt to [...]
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, which outline the standards for ingredient statements, net quantity of contents, warnings, and allergen declarations. Non-compliance can lead to misbranding, [...]
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), FDA inspections of cosmetic facilities are expected to increase, making compliance readiness more critical than ever. Companies that are unprepared [...]
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 for consumer use and must not include substances that are prohibited or restricted under U.S. regulations. Failure to comply can [...]
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 can result in costly delays, product detentions, or even refusals at the port of entry. The FDA, in coordination with [...]
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 to undergo pre-market approval (except for color additives), manufacturers must follow industry-recognized GMP standards to prevent contamination, mislabeling, and product [...]
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 adverse event and safety reporting. The FDA requires manufacturers, packers, distributors, and importers to maintain systems for documenting and reporting [...]