Original source
Guidance / Q&A
pdf Compliance Policy for Cosmetic Product Facility Registration and Cosmetic
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Instrument: Compliance Policy Guide (CPG). Issued by: U.S. Food and Drug Administration (FDA). Scope: Cosmetic product facility registration and cosmetic product listing under the Modernization of Cosmetics Regulation Act (MoCRA). Purpose: Provides guidance to FDA staff on enforcement priorities and circumstances under which FDA may exercise enforcement discretion. Key points: The CPG describes factors FDA may consider when deciding whether to initiate enforcement action for failure to register or list. Note: This is a guidance document, not a regulation; it does not create legally enforceable rights or obligations.
FDA has issued a compliance policy guide addressing registration and listing obligations under MoCRA. The document outlines FDA's enforcement approach for cosmetic facility registration and product listing. Businesses should review the policy to understand current compliance expectations.
Official text
English translation — the official-language text prevails
This document is a Compliance Policy Guide (CPG) issued by the U.S. Food and Drug Administration (FDA). It provides guidance to FDA staff on the agency’s enforcement policy regarding registration of cosmetic product facilities and listing of cosmetic products, as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Modernization of Cosmetics Regulation Act (MoCRA). The CPG outlines the circumstances under which FDA may exercise enforcement discretion and the factors FDA may consider in determining whether to initiate enforcement action. This guidance does not establish legally enforceable responsibilities and does not bind the public or FDA.