In light of the recent FDA Guidance delaying Enforcement of Product & Facility Registration (only) until July 1, 2024, here’s revised guidance. To be clear, all of MoCRA has NOT been delayed until July 1, 2024.

Your product label should contain the declarative statement identifying the Responsible Person (ie: The Brand) in either of these formats:

Manufactured For Distribution By
Your Company Name
Your Company Address
Your Company Telephone Number

Or,

Manufactured For Distribution By
Your Company Name
Your Company Website
Your Company E-Mail

Your label is compliant with MoCRA if you have any combination of (1) Company Name (absolutely necessary); and (2) Mailing Address or Website; and (3) E-Mail Address or Phone Number. Any combination of these identifiers provides adequate information to consumers to contact your company to report an Adverse Event.

If your Company had revenues of $1.0 million or more (cumulative) in cosmetic product sales in the US over the previous 3 years, then here is what you must do to be in compliance with MoCRA:

DECEMBER 29, 2023 Deadline

(1)  Maintain a Safety Substantiation Dossier on each of your products comprised of
(a)  Preservative Challenge Test
(b) Cosmetic Ingredient Safety (Toxicology) Report (essentially an EU CSPR “lite”)
(c)  At your discretion, Patch Testing. Note, retailers may require Patch Testing for your products to be listed on their website or in their brick and mortar stores.

(2)  Set up an Adverse Event Reporting Standard Operating Procedure, maintain records of all Adverse Events that do not require medical attention and report all Serious Adverse Events (those that did require medical attention) to the FDA within 15 days of being notified by a consumer of the Adverse Event. Read more here: ( https://lnkd.in/eciwT6h6 ). AE/SAE Records must be maintained for a period of 6 years.

JULY 1, 2024 Deadline:

(1)  Register your products with the FDA in the upcoming Cosmetics Direct Portal

If your products contain Fragrances or Essential Oils, the FDA will finalize its list of Fragrance Allergens that must appear on your label by December 29, 2024.  Wait until the FDA finalizes its list of Fragrance Allergens (mid-year 2024) before making any changes to your product labels if your labels are currently compliant.

If you are non-US firm selling cosmetics products in the US market, then you must hire a US Agent to represent your firm for MoCRA product registration.

Contact Bloom Cosmetic Test Lab (https://lnkd.in/eiS2U2G4) if you need assistance with MoCRA compliance. We offer a comprehensive MoCRA Compliance Officer service and individual MoCRA Compliance services.