The MoCRA contact line: the label rule small makers keep missing
The Modernization of Cosmetics Regulation Act (MoCRA) rewired US cosmetics law. Most coverage focuses on facility registration — but the requirement that actually touches every label you print is smaller and easy to miss.
The rule
FD&C Act §609(a) (added by MoCRA): every cosmetic product label must bear a domestic address, domestic phone number, or electronic contact information (FDA has indicated a website can qualify) through which the responsible person can receive adverse-event reports. The responsible person is the manufacturer, packer or distributor whose name appears on the label. This has been the law for products since December 29, 2024.
“But I'm under $1M — I'm exempt, right?” — No.
The small-business exemption (average gross sales under $1M over three years) covers facility registration, product listing and GMP — it does not exempt you from the §609(a) label requirement, nor from adverse-event recordkeeping. If you sell cosmetics, your label needs the contact line. Period.
What satisfies it in practice
- Your full US street address already on the label (the 21 CFR 701.12 business line) — satisfies it; note that the old “omit the street if you're in the phone directory” shortcut undermines the purpose of reachability;
- A US phone number;
- A website or email — the cheapest, cleanest option for most makers: print yourbrand.com and make sure messages there reach you.
What “adverse event” means for you
A health-related complaint tied to your product (rash, burn, infection…). You must keep records (6 years; 3 for the smallest firms) and report serious adverse events to FDA within 15 business days. The label contact exists so a customer can actually reach you to start that clock.
Check your whole label in one pass
The Inkurate generator validates the MoCRA line automatically — alongside INCI ordering, warnings, net contents and the rest — and cites the rule for each element. Free preview, $7 for the print-ready file.