MoCRA is the biggest expansion of FDA authority over cosmetics since 1938. Here's what small brands must do now — safety substantiation, adverse event reporting — and which parts small businesses are exempt from.
Published August 25, 2026 · By Formulate 360 Team· Topics: mocra requirements small business, mocra explained, mocra small business exemption
MoCRA is the Modernization of Cosmetics Regulation Act of 2022— the most significant expansion of the FDA's authority to regulate cosmetics since the FD&C Act was passed in 1938. CONFIRMED FDA MoCRA page.
For indie beauty brands, the short version: cosmetics now have a real regulatory floor in the US, and a lot of it is already in effect.Some of it applies to every brand, including small ones. Some of it small businesses are exempt from. The mistake most indie founders make is guessing which is which — usually in the expensive direction, either over-buying compliance they don't need or ignoring obligations that hit them regardless.
This page separates the two.
Three obligations are live now and there is no small-business carve-out for them. CONFIRMED FDA MoCRA page.
What counts as a “serious adverse event”? Death, a life-threatening experience, inpatient hospitalization, persistent or significant disability/incapacity, a congenital anomaly or birth defect, an infection, or significant disfigurement — or a medical intervention needed to prevent one of those. CONFIRMED FDA MoCRA page.
Who is the “responsible person”? The manufacturer, packer, or distributor whose name appears on the label. For an indie brand using a contract manufacturer, that is usually you — your brand name is on the label, so the SAE-reporting and safety-substantiation burden sits with you, not your manufacturer. CONFIRMED FD&C Act § 609(a) / FPLA § 4(a), via FDA MoCRA page.
Two more obligations exist, and here the small-business exemption actually helps most indie brands. CONFIRMED FDA registration & listing page; FDA small-business guidance.
The small-business threshold:a “small business” is a responsible person (or facility owner/operator) whose average gross annual sales in the US of cosmetic products over the previous 3-year period is less than $1,000,000, adjusted for inflation. Small businesses are exempt from registration, listing, and GMP. CONFIRMED FDA guidance.
Three caveats that matter:
CONFIRMED status as of the FDA's published materials, reviewed 2026-08-10 — this section will age; re-check FDA before relying on it.
As of June 30, 2026, there were 16,398 active facility registrations and 1,298,361 active product listings in FDA's cosmetics program. CONFIRMED FDA registration & listing page. The program is real, it is scaled, and the FDA has new tools: records access (it can inspect safety and adverse-event records) and mandatory recall authority (it can order a recall for an adulterated or misbranded cosmetic that would cause serious adverse health consequences or death). CONFIRMED FDA MoCRA page.
Enforcement posture (our read, not a legal opinion):so far the FDA's visible enforcement focus has been registration/listing deadlines, mandatory recall, and SAE reporting. ESTIMATE routine GMP inspections and systematic safety-substantiation enforcement are the areas most likely to intensify once a final GMP rule lands — that's the event indie brands should prepare for now, while it's cheap to do so.
A formulation workspace can't file your registrations or certify your safety — and anyone who says otherwise is selling something. CONFIRMED registration/listing is filed directly with FDA; no private certificates exist. What it can do is generate and organize the records MoCRA expects: safety substantiation trails, batch records, adverse-event logs, label declarations. That documentation is the wedge. The compliance review in Formulate360 flags restricted ingredients, use-level concerns, and labeling gaps against current cosmetics expectations, and keeps the record trail you can build on. You still own the final call — every output is formulation assistance, not a substitute for a qualified formulator or regulatory professional.
I'm a solo founder selling 200 jars a month. Does MoCRA apply to me?
Yes. Safety substantiation and adverse event reporting apply to every responsible person. You're likely exempt from registration/listing/GMP if you're under the $1M/3-year threshold and don't make the carve-out product types — but the record-keeping obligations are live regardless.
Does FDA approve cosmetics?
No. Registration and listing are not approval, and FDA issues no certificates. Cosmetic products do not get "FDA approved" — any claim that they do is a red flag.
My contract manufacturer handles compliance, right?
Partly. If your brand name is on the label, you are the responsible person for safety substantiation and adverse event reporting. The manufacturer may help, but the obligation follows the label.
When did this all start?
The core obligations (safety substantiation, SAE reporting, AE recordkeeping, registration, listing) have been in effect since December 29, 2023. GMP remains draft guidance as of this writing.
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