MoCRA label contact information for foreign cosmetic brands
MoCRA requires cosmetic labels to provide a domestic address, domestic phone number, or electronic contact information through which the responsible person can receive adverse event reports. For a foreign brand, checking the label means reviewing that contact route and its intended function, while separately considering the name-and-place-of-business requirement.
What §609(a) asks the label to carry
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added section 609 to the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. 364e. Section 609(a) has applied to cosmetic labels since December 29, 2024.
Under §609(a), the label of a cosmetic product must bear one of these, through which the responsible person can receive adverse event reports:
a domestic (United States) address,
a domestic phone number, or
electronic contact information, which may include a website.
The responsible person is the manufacturer, packer or distributor whose name appears on the label.
How it differs from the name and place of business
A cosmetic label also has to state the name and place of business of the manufacturer, packer or distributor under 21 CFR 701.12, with a qualifying phrase such as "Distributed by" when the firm named is not the manufacturer.
That declaration can name a business located outside the United States. A label from a foreign brand can therefore meet 701.12 with its home address and still lack the §609(a) contact. They are two separate elements, and a review should check both.
Two demonstration labels.
Both labels are fictional demonstration artwork from the sample report.
Yes. Section 609(a) accepts a domestic address, a domestic phone number, or electronic contact information, which may include a website. Any one of the three can serve as the contact route, as long as the responsible person can receive adverse event reports through it.
Is this the same as the business-address declaration?
No. The name and place of business under 21 CFR 701.12 identifies the manufacturer, packer or distributor and can be an address outside the United States. The §609(a) contact is a separate element: a US address, a US phone number or electronic contact information for adverse event reports.
Can the software verify that the contact channel works?
No. A label review can check whether a qualifying contact route appears on the label. It cannot confirm that the phone line, address or website actually reaches the responsible person or that reports are handled.
