Tag: US FDA cosmetic compliance
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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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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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How to Get an FEI Number: Complete Guide for Cosmetic Facilities
The FDA Establishment Identifier (FEI) is a unique number assigned by the US FDA to identify facilities that manufacture, process, pack, or hold regulated products, including cosmetics. Under the Modernization of Cosmetics Regulation Act (MoCRA), facility identification and traceability have become central to cosmetic regulatory compliance, making FEI numbers increasingly important for cosmetic manufacturers and…
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Cosmetic Good Manufacturing Practices (GMP): Building Compliance Under US FDA and MoCRA
In today’s regulatory environment, product safety begins long before a cosmetic reaches the shelf. It starts inside the manufacturing facility. Cosmetic Good Manufacturing Practices (GMP) are the operational foundation that ensures products are consistently produced and controlled according to quality standards. Under the authority of the US FDA, and reinforced by the Modernization of Cosmetics…
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PFAS in Cosmetics: US FDA Regulatory Expectations and MoCRA Compliance Strategy
Per- and polyfluoroalkyl substances (PFAS) have become one of the most scrutinized chemical groups in consumer products, including cosmetics. Often referred to as “forever chemicals,” PFAS are valued for their water-resistant, oil-resistant, and long-lasting properties. However, concerns about persistence in the environment and potential health risks have drawn increased regulatory attention. Under the authority of…
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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…
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Annual Cosmetic Product Listing Update: Keeping Product Data Current Under MoCRA
The Modernization of Cosmetics Regulation Act (MoCRA) established cosmetic product listing as a mandatory requirement for all cosmetic products marketed in the United States. Beyond initial listing, MoCRA also requires companies to perform an annual cosmetic product listing update with the US FDA. An annual update confirms that product information on file remains accurate and…
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Biennial Cosmetic Facility Registration Renewal: Maintaining Continuous US FDA Compliance
The Modernization of Cosmetics Regulation Act (MoCRA) introduced mandatory cosmetic facility registration with the US FDA, but registration is not a one-time obligation. To remain compliant, cosmetic manufacturers and processors must complete a biennial cosmetic facility registration renewal—a renewal that occurs every two years. This renewal process ensures that the US FDA maintains accurate and…