Federal registration

US Cosmetics Law Guide (MoCRA)

The Modernization of Cosmetics Regulation Act of 2022 () is the biggest change to US cosmetic law in more than 85 years. It added registration, listing, safety records and adverse event reporting on top of the labeling rules that already existed. Here is what it means for a small brand.

Small business exemption screener

Two questions. This tells you whether you are exempt from facility registration and product listing — nothing else.

Is your average gross annual sales in the US for the previous 3 years under $1,000,000?

Does any product you sell fall into one of the excluded categories below?

Products that regularly contact the eye mucous membrane — Such as eyeliner or mascara applied inside the lash line, under normal conditions of use.
Injected products — Anything intended to be injected is never exempt.
Products intended for internal use — Anything meant to be ingested or used internally.
Products that alter appearance for more than 24 hours — Where removal by the consumer is not part of normal use, such as semi-permanent tints.

The full obligation list

1
Get your FDA account and FEI number
Register for an FDA Industry Systems account, then request a Facility Establishment Identifier (FEI) number for the place where you manufacture or process. Small businesses under the exemption do not need this.
2
Register your facility
Facility registration is submitted through Cosmetics Direct and renewed every two years. Include the facility address, brand names made there and the product categories.
3
List every cosmetic product
Each marketed product needs its own listing with its ingredient list, product category and responsible-person contact details. Listings are updated annually.
4
Name a Responsible Person
This is the manufacturer, packer or distributor whose name appears on the label. That is the contact the FDA and consumers use for adverse events.
5
Keep safety substantiation records
You must hold evidence that the product is safe: preservative efficacy (challenge) testing, stability data, supplier certificates of analysis, ingredient safety literature and final pH records.
6
Track and report adverse events
Keep adverse-event records for six years (three years for small businesses). Serious adverse events must be reported to the FDA within 15 business days.
7
Add a contact for adverse events to the label
Your label needs a domestic address, phone number or electronic contact through which a consumer can report a reaction.
8
Fragrance allergen disclosure
Once the FDA rule is final, listed fragrance allergens must be named on the label rather than hidden behind the word "fragrance".

What a safety substantiation file holds

Final formula with exact percentages and the batch record for each production run.
Preservative efficacy (challenge) test results for every water-containing product.
Stability data — typically 12 weeks at 40°C plus freeze/thaw cycles.
Final measured pH of each batch, with the target range.
Supplier certificates of analysis and safety data sheets for every raw material.
Published safety literature or a cosmetic safety assessment for each ingredient at your use level.
Packaging compatibility notes and the adverse event log.

The Batch Records tool and the Shelf Life estimator produce two of these documents directly from your formula.

Next: the labeling guide →Back to the hub

Educational reference, not legal advice. Registration deadlines and the fragrance allergen rule continue to evolve — confirm current requirements with the FDA before you file.