MoCRA label requirements: Responsible Person and adverse-event contact

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added the single newest line to a U.S. cosmetic label: an on-label way for the Responsible Person to receive adverse-event reports. Here is exactly what MoCRA requires, who the Responsible Person is, and the wording our checker generates.

What MoCRA is

MoCRA is the largest expansion of FDA's cosmetics authority since 1938. It amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add facility registration, product listing, safety substantiation, serious adverse-event reporting, and — the part that lands on the label — a contact through which consumers can report adverse events. The labeling provision is FD&C Act §609 (21 U.S.C. 364h).

Who is the "Responsible Person"?

Under MoCRA, the Responsible Person is the manufacturer, packer, or distributor whose name appears on the label per FD&C Act §609(a) or §4(a) of the Fair Packaging and Labeling Act. In plain terms: whoever's name is on the label as the firm behind the product is the Responsible Person, and they carry the registration, listing, safety-substantiation, and adverse-event duties.

The on-label adverse-event contact

FD&C Act §609(a) requires each cosmetic product label to bear a means through which the Responsible Person can receive adverse-event reports. Per the statute, that contact may be a domestic address, a domestic phone number, or electronic contact information — and the electronic contact may be a website (an email address also works). This on-label contact requirement took effect December 29, 2024; because MoCRA is still being implemented, treat enforcement as settling and verify against current FDA guidance before a long print run.

Any one of these formats satisfies the statute:

Source: FD&C Act §609(a) (21 U.S.C. 364h), added by the Modernization of Cosmetics Regulation Act of 2022; on-label contact effective December 29, 2024.

Reporting to FDA is separate from the label line

The on-label contact lets consumers reach you. Separately, the Responsible Person must report serious adverse events to FDA within 15 business days, and keep records of all adverse events, under FD&C Act §605. Do not confuse the two: a phone number on your label does not satisfy your duty to file serious events with FDA.

Fragrance-allergen labeling is coming, but rule-dependent

MoCRA also directs FDA to require that cosmetic labels identify certain fragrance allergens — but only once FDA defines those allergens by regulation. Until that final rule is in force, there is no fixed fragrance-allergen list to print. Watch for FDA's rulemaking and confirm current requirements before relying on this.

What else has to be on the label

MoCRA is layered on top of the existing FD&C Act and FPLA requirements — it does not replace them. A compliant U.S. cosmetic label still needs a statement of identity, the net quantity of contents, the name and place of business, and the ingredient declaration. See the full FDA cosmetic labeling checklist →

Informational only — not legal advice. Verify against the current governing standard before printing. LabelClear generates text from published rule data and does not guarantee regulatory approval.