Tag: What are the FDA rules for cosmetics?
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Cosmetic Adverse Events: US FDA Requirements, MoCRA Rules, and Compliance Obligations
Cosmetic safety does not end once a product reaches the market. Under United States law, cosmetic companies are legally responsible for monitoring, documenting, and reporting cosmetic adverse events. With the enactment of the Modernization of Cosmetics Regulation Act (MoCRA), adverse event reporting has become a mandatory and enforceable requirement under the authority of the US…
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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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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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Warning Statements in Cosmetic Labeling: US FDA Requirements and Compliance Obligations
Warning statements are a critical component of cosmetic labeling in the United States. Their purpose is to alert consumers to potential hazards associated with product use and to provide instructions that reduce the risk of injury or misuse. Under the authority of the US FDA, and reinforced by the Modernization of Cosmetics Regulation Act (MoCRA),…
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Net Quantity of Contents on Cosmetic Labels: US FDA Requirements Explained
The net quantity of contents statement is one of the most fundamental and strictly enforced cosmetic labeling requirements in the United States. It tells consumers exactly how much product they are purchasing and allows fair comparison between products. Under the authority of the US FDA, and reinforced by the Modernization of Cosmetics Regulation Act (MoCRA),…
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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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Cosmetic Product Safety Substantiation: Building Scientific Proof of Safety Under MoCRA
Cosmetic safety in the United States is no longer based on informal assurances or internal opinions. With the enactment of the Modernization of Cosmetics Regulation Act (MoCRA), cosmetic companies are now legally required to maintain adequate safety substantiation for every cosmetic product marketed in the United States. Under the authority of the US FDA, cosmetic…
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US FDA Mandatory Cosmetic GMP: What MoCRA Means for Cosmetic Manufacturing Compliance
The regulatory expectations for cosmetic manufacturing in the United States have changed dramatically with the passage of the Modernization of Cosmetics Regulation Act (MoCRA). One of the most important outcomes of MoCRA is the clear movement toward mandatory Cosmetic Good Manufacturing Practices (GMP) under the authority of the US FDA. While cosmetic GMP was historically…