Tag: FDA approved cosmetics list
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OTC Cosmetic Products: How US FDA Regulates Cosmetics With Drug Functions
Many personal care products in the US marketplace appear to be simple cosmetics, yet they also perform therapeutic functions. These products are commonly referred to as OTC cosmetic products, meaning they have both cosmetic and over-the-counter (OTC) drug characteristics. Under the authority of the US FDA, products that both beautify and treat or prevent certain…
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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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Imported Cosmetics FDA Requirements: Complete Compliance Guide for Foreign Brands
Selling cosmetics in the United States is a major business opportunity—but it comes with strict regulatory obligations. Imported cosmetic products must fully comply with laws enforced by the US FDA, just like domestically manufactured products. There are no relaxed standards for foreign manufacturers. With the enactment of the Modernization of Cosmetics Regulation Act (MoCRA), the…
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Cosmetic Product Claims: How US FDA Regulates What You Can and Cannot Say
Cosmetic product claims are one of the most common sources of regulatory violations in the United States. While cosmetic labels and marketing materials are powerful tools for attracting consumers, they are also closely regulated by the US FDA. Claims that overstep legal boundaries can cause a cosmetic to be misbranded, reclassified as a drug, or…
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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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US FDA Cosmetic Regulations: Complete Compliance Guide for Cosmetic Manufacturers & Brands
The United States cosmetic market is one of the most highly regulated and competitive industries in the world. Any company planning to manufacture, distribute, import, or sell cosmetic products in the United States must comply with strict US FDA cosmetic regulations. Failure to meet these requirements can lead to warning letters, product seizures, import alerts,…
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US FDA Cosmetic Registration: Complete Guide for Cosmetic Brands Selling in the US Market
By XPRO America – US FDA Consultancy The global cosmetic industry is growing rapidly, but when it comes to selling cosmetics in the United States, FDA cosmetic registration is a critical compliance requirement that brands cannot ignore. Many cosmetic manufacturers and brand owners believe cosmetics are “free from regulation,” only to face shipment delays, buyer…