Tag: FDA Cosmetics regulations
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Drug vs Cosmetic Intent: How US FDA Determines Product Classification
One of the most critical regulatory questions for any personal care product is whether it is legally considered a cosmetic, a drug, or a combination product. This determination is driven primarily by product intent, which is evaluated based on claims, labeling, marketing, and consumer perception. Under the authority of the US FDA, product intent defines…
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Adulterated Cosmetics: Understanding US FDA Enforcement and MoCRA Compliance
Under United States law, cosmetic products must be safe for consumers under their intended conditions of use. When a cosmetic fails to meet safety or manufacturing standards, it may be classified as adulterated. An adulterated cosmetic is illegal to distribute in the United States and may trigger enforcement action by the US FDA. With the…
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Misbranded Cosmetics: How US FDA Defines, Detects, and Enforces Violations
Under United States law, cosmetic products must be labeled and marketed in a truthful, accurate, and non-misleading manner. When a cosmetic fails to meet these legal standards, it is considered misbranded. A misbranded cosmetic is illegal to distribute in the United States and may trigger enforcement action by the US FDA. With the implementation of…
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Prohibited Cosmetic Ingredients: Understanding US FDA Restrictions and Compliance Obligations
Cosmetic safety in the United States is grounded in the principle that products must not contain ingredients that are harmful to consumers. Under the authority of the US FDA and reinforced by the Modernization of Cosmetics Regulation Act (MoCRA), cosmetic companies are legally responsible for ensuring that their products do not contain prohibited cosmetic ingredients.…