Author: admin
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Cosmetic Ingredient Safety: How US FDA Evaluates and Enforces Safe Cosmetic Formulations
Ingredient safety is the foundation of cosmetic compliance in the United States. Every cosmetic product placed on the US market must be safe for its intended use, and the responsibility for ensuring this safety lies with the manufacturer and brand owner. Under the authority of the US FDA and strengthened by the Modernization of Cosmetics…
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Form FDA 3500A and Cosmetic Adverse Event Reporting: Regulatory Reporting Under MoCRA
The Modernization of Cosmetics Regulation Act (MoCRA) fundamentally changed how cosmetic safety issues must be reported in the United States. Cosmetic companies are now legally required to report serious adverse events associated with their products to the US FDA within defined timelines. One of the primary tools used to fulfill this obligation is Form FDA…
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US FDA Establishment Identifier (FEI) for Cosmetics: What It Is and Why It Matters Under MoCRA
As cosmetic regulation in the United States becomes more structured under the Modernization of Cosmetics Regulation Act (MoCRA), identification and traceability of manufacturing facilities have become central to compliance. One of the key identifiers used by the US FDA is the FDA Establishment Identifier (FEI). The FEI number is a unique numeric identifier assigned by…