Cosmetics · United States

FDA Cosmetics — FD&C Act & MoCRA 2022 Compliance

FDA Cosmetics — FD&C Act & MoCRA 2022 is issued by US Food & Drug Administration and has applied since 2022-12-29. It applies to products sold in US. Below: what it covers, which products trigger it, the documents a supplier must provide, and how Complyra checks a product against it.

Authority: US Food & Drug Administration
Jurisdiction: United States
Regions: US
Effective: 2022-12-29
Evidence renewal: every 730 days
Official source: https://www.fda.gov/cosmetics/cosmetics-laws-regulations

What FDA Cosmetics — FD&C Act & MoCRA 2022 covers

FDA Cosmetics — FD&C Act & MoCRA 2022 is a cosmetics requirement in United States. In Complyra's dataset it is triggered by products in the following categories and by product descriptions that mention the keywords listed below.

Product categories affected

personal care

Keywords that trigger a check

cosmetic
skincare
makeup
shampoo
lotion
sunscreen
lip
nail
hair dye

Who it applies to

Buyers importing or placing the affected products on the market in US, and the suppliers who manufacture or distribute them. In a procurement workflow the buyer is responsible for obtaining the evidence listed below from the supplier before the order is placed.

Consequences of non-compliance recorded in the dataset: FDA Warning Letter, import alert, recall

Restricted substances and materials

Substance	Limit	Unit
Color additives	—	must be FDA-approved

Materials and conditions that fail the check

color additives not approved by FDA
chloroform
halogenated salicylanilides

Supplier requirements and compliance evidence

Documents a supplier should be able to provide for products in scope. Ask for these in the RFQ rather than after the goods ship.

Document
FDA Facility Registration (MoCRA)
Product Listing with FDA
Serious Adverse Event Reporting procedure
Safety substantiation records
Full ingredient list (INCI names)
Warning statements if required

Certification types recorded for this regulation

FDA facility registration
product listing

How Complyra checks FDA Cosmetics — FD&C Act & MoCRA 2022

When a product is searched or sourced in Complyra, its category and description are matched against the trigger categories and keywords above. If FDA Cosmetics — FD&C Act & MoCRA 2022 applies, the product and its supplier are checked against the materials, substance limits and required documents recorded for the regulation, and the result is shown alongside the supplier match, before an RFQ is generated.

Suppliers on Complyra register and upload certifications that are reviewed by an administrator; see supplier compliance for how that review works and supplier sourcing for how compliant suppliers are found and matched.

Complyra checks product and supplier information against regulatory requirements to support procurement decisions. It does not issue certifications or guarantee legal compliance; final responsibility for compliance remains with the buyer and supplier.