Implementing MoCRA: FDA Releases New Draft Guidances on Insanitary Conditions for Tattoo Ink and Cosmetic Product Registration & Listing - Food and Drug Law Institute (FDLI)
FDA released two new draft guidances under MoCRA: one on insanitary conditions for tattoo ink and another on cosmetic product registration and listing. These guidances clarify compliance expectations for facility registration, product listing, and safety substantiation.
Aforeworn detected this change in the Cosmetics & Personal-Care (MoCRA) space on July 7, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Indie beauty brands, contract manufacturers, private-label makers, importers/distributors should confirm how it applies to their specific situation before acting. There is a time constraint attached: Comment period ends 60 days after publication in Federal Register; compliance expected by end of 2024.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Cosmetics & Personal-Care (MoCRA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA issued draft guidances detailing insanitary conditions for tattoo inks and procedures for cosmetic product registration and listing under MoCRA.
Who it affects
Indie beauty brands, contract manufacturers, private-label makers, importers/distributors
What you must do
Review draft guidances and prepare to update registration and listing processes; ensure tattoo ink products meet sanitary standards.
Deadline
Comment period ends 60 days after publication in Federal Register; compliance expected by end of 2024.
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- Illinois Governor Signs Bill Banning Intentionally Added PFAS in Certain Consumer Products and Requiring IEPA to Prepare Report on Fluoropolymers by August 1, 2027 - Bergeson & Campbell
- FDA Final Guidance on Cosmetic Facility Registration and Product Listing: Take Two - ArentFox Schiff
- FDA Launches Cosmetics Direct and Issues Final Guidance on Facility Registration & Product Listings Required under MoCRA - Crowell & Moring LLP