NCQM — National Committee for Quality Management

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Industry reference

Cosmetics & Personal Care

Ingredients, intended use and claims determine whether a personal care product is a cosmetic, a drug or both. MoCRA responsibilities, safety substantiation and labeling need a product-specific review rather than a generic claim that cosmetics are FDA certified.

A product-specific review

Move from scope to evidence

  1. Define the product and activity

    Examine ingredients, intended use and promotional presentation to establish whether the product is a cosmetic, drug or both. Claims can change the pathway even where the formulation is unchanged. Resolve color additive and other ingredient-specific questions as part of the product review.

  2. Connect requirements to evidence

    Connect safety substantiation to the actual formulation, use conditions and intended users. Review applicable MoCRA facility and product responsibilities with their exemptions and conditions. Keep the basis of the safety conclusion accessible to the responsible organization rather than relying on a generic supplier assurance.

  3. Review interfaces and changes

    Maintain labeling, adverse event and complaint controls for the released product. Distinguish current requirements from proposed rules and agency guidance. Reassess evidence when ingredients, exposure, packaging or claims change; do not describe a future rulemaking obligation as an already completed certification pathway.

3 source profiles

Requirements and technical resources

Review the references relevant to your product and activity. This selected federal collection does not replace a separate review of applicable state, local or contractual requirements.

Statutory or administrative frameworkFDA

Cosmetics: MoCRA Registration, Listing and Safety Responsibilities

FD&C Act sections 605–609 and 612, as added by MoCRA

MoCRA expanded FDA’s cosmetics authorities and imposed responsibilities concerning adverse events, safety substantiation, facility registration and product listing. Covered facilities and responsible persons have different roles. Registration and listing are operational reporting requirements, not approval of products or facilities. Exemptions must be assessed against the statutory conditions, while separate rulemaking subjects must be tracked according to their actual status.

Cosmetics & Personal Care

Federal regulationFDA

Cosmetics: Product Identity, Ingredients and Label Presentation

21 CFR Part 701; related warnings in Part 740

Cosmetic labeling combines product identity, business information, net contents and ingredient declarations with readable presentation. Requirements differ between the immediate container and outer retail packaging, and particular exceptions must be checked carefully. A truthful cosmetic label also depends on the product’s intended use: therapeutic or body-function claims can raise drug requirements. MoCRA adds responsibilities that must be considered alongside the established labeling rules.

Cosmetics & Personal Care

Statutory or administrative frameworkFDA

OTC Drugs: Monographs and Administrative Orders

FD&C Act section 505G; applicable OTC monograph administrative orders

The OTC monograph pathway permits qualifying nonprescription drugs to be marketed without an approved drug application when section 505G and other applicable requirements are met. Administrative orders establish or change the relevant conditions. The assessment concerns a therapeutic category, active ingredients, uses, doses, routes, labeling and testing, not simply whether a product is sold without a prescription.

Pharmaceuticals & BiologicsCosmetics & Personal Care

Build a defensible review record

Identify the product configuration, the controlling provision and edition, the evidence required and the person authorized to make the decision. Keep a reason for exclusions and unresolved questions alongside confirmed requirements.

Revisit the record when design, materials, suppliers, software, claims or the applicable source changes. An earlier report remains useful only to the extent that it supports the current configuration and requirement.

Practice guidance