Tag: FDA cosmetic regulations 2025
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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 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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Responsible Person for Cosmetics Under US FDA: Legal Role, Duties, and Compliance Requirements
The Modernization of Cosmetics Regulation Act (MoCRA) introduced a major structural change in how cosmetic products are regulated in the United States. One of the most important concepts established under MoCRA is the designation of a Responsible Person for cosmetic products. The Responsible Person is the legally accountable party for ensuring that each cosmetic product…
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Modernization of Cosmetics Regulation Act of 2022 (MoCRA): Comprehensive Compliance Guide for Cosmetic Brands
In December 2022, the United States enacted a landmark law that fundamentally reshaped cosmetic regulation—the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This legislation represents the most significant update to cosmetic law in over 80 years and dramatically expanded US FDA authority over cosmetic products marketed in the United States. Before MoCRA, cosmetic regulation…
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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…