MoCRA Compliance Notice

Last updated: 2026-05-01

The Modernization of Cosmetics Regulation Act of 2022 ("MoCRA") gives the U.S. Food and Drug Administration significant authority over cosmetic products. This notice explains how Cosmixxology approaches MoCRA. It is informational; it is not a substitute for legal advice.

[TODO before launch: confirm with FDA-cosmetics counsel which entity is the "Responsible Person" for each product made on the Cosmixx Machine, complete facility registration in FDA Cosmetic Direct, and finalize labeling artwork.]

1. Responsible Person

MoCRA assigns a "Responsible Person" for each cosmetic product distributed in the United States — typically the manufacturer, packer, or distributor whose name appears on the product label. For products formulated by Cosmixxology and dispensed via the Cosmixx Machine at a partner Salon, our intended structure is:

  • Cosmixxology, Inc. acts as the Responsible Person for facility registration and product listing under 21 U.S.C. §§ 364a–364b.
  • Partner Salons act as our authorized operators of the dispensing equipment, follow our published Standard Operating Procedure, and route any adverse-event report to us.

The exact allocation will be finalized in the order form Salons sign and may differ for jurisdictions outside the United States.

2. Facility registration & product listing

We register each manufacturing facility (including any third-party blender that mixes ingredients on our behalf) with FDA via Cosmetic Direct, and we file a product listing for each cosmetic product distributed in the United States. We renew registrations and update listings on the cadence required by FDA regulations.

3. Labeling

Every product label includes the information required by 21 CFR Part 701 and 21 U.S.C. § 363b, including:

  • Identity of the product and its intended use;
  • Net quantity of contents;
  • Name and place of business of the Responsible Person;
  • An ingredient declaration in INCI nomenclature, in descending order of predominance;
  • For products containing fragrance allergens, the disclosures required by 21 CFR § 701.13(c) and any applicable state-level requirements;
  • For products marketed as "professional use only", the additional warning statements required under MoCRA;
  • A means for U.S. consumers to report an adverse event (email or U.S. address).

4. Adverse-event reporting

4.1 Tell us

If you experience a serious adverse event after using a Cosmixxology product — for example, persistent rash, hair loss, infection, or an effect that requires medical attention — please report it to support@cosmixxology.com with the product name, batch number, date of use, and a description of what happened. You can also contact FDA directly at FDA MedWatch.

4.2 We tell FDA

For any serious adverse event we receive, we will submit a report to FDA within fifteen (15) business days as required by MoCRA, and we will keep records for at least six (6) years.

5. Good Manufacturing Practice (GMP)

We maintain a Good Manufacturing Practice program covering the Cosmixx Machine, ingredient handling, sanitation, batch records, calibration, and complaint handling. Salons are trained on the GMP elements that apply to their on-site operations.

6. Safety substantiation

Each formula combination that the Cosmixx Machine can dispense is substantiated as safe for its intended use under § 364d of MoCRA. Substantiation includes published safety data, in-house assessments by qualified persons, and the allergen-screening logic the AI applies before producing a recipe.

7. Recalls

If we issue a voluntary recall, we will post notice here and email affected customers. Where FDA orders a mandatory recall, we will comply on the timeline specified.

8. State-specific requirements

Some states impose additional cosmetics requirements (for example, California Proposition 65 warnings, or state "clean beauty" ingredient bans). Where a state ban applies, the Cosmixx Machine will not produce a formula containing the prohibited ingredient for shipment to that state.

9. Outside the United States

For shipments to other countries we comply with the local cosmetics regime (for example, the EU Cosmetic Products Regulation 1223/2009, the UK Cosmetic Products Enforcement Regulations 2013, Health Canada Cosmetic Notification, etc.). Local requirements may add labeling, registration, or formulation restrictions and may prohibit certain ingredients we offer in the United States. See also our Shipping & Returns Policy.

10. Contact

support@cosmixxology.com (consumer reports) · legal@cosmixxology.com (regulator inquiries)