Who is the Responsible Person?
The Responsible Person is the manufacturer, packer or distributor whose name appears on the cosmetic label. For most brands, that is the brand owner, not the factory. A foreign company can be the Responsible Person.
What the Responsible Person must do
- List each product with FDA and update listings every year. See the listing guide.
- Put a contact on the label for adverse event reports: a U.S. address, U.S. phone number or electronic contact such as a website.
- Report serious adverse events to FDA.
- Keep adverse event records.
- Keep safety substantiation: records showing that each product and its ingredients are safe when used as intended.
Serious adverse event reporting
A serious adverse event is one that results in death, a life-threatening experience, hospitalization, lasting disability, a birth defect, an infection, or significant disfigurement such as serious burns, hair loss or lasting changes in appearance, or that needs medical treatment to prevent one of these outcomes.
| Report to FDA | Within 15 business days of receiving the report, with a copy of the label |
|---|---|
| New medical information | Send to FDA within 15 business days, for one year after the first report |
| Keep records of all adverse events | 6 years (3 years for qualifying small businesses) |
Reports are sent through FDA's MedWatch system. FDA publishes cosmetic adverse event data on a public dashboard.
Safety substantiation
The Responsible Person must have adequate proof that each product is safe. This usually means ingredient safety data, test results and published research. A product without adequate substantiation is considered adulterated. Keep these records ready in case FDA asks for them.
Questions
Can a foreign brand be the Responsible Person?
Yes. But the label still needs a U.S. address, U.S. phone number or electronic contact for adverse event reports.
Do small businesses have to report adverse events?
Yes. The small-business exemption covers registration, listing and future manufacturing rules, not adverse event reporting. Small businesses keep records for 3 years instead of 6.
Is the U.S. Agent the Responsible Person?
No. The U.S. Agent is FDA's contact for a foreign facility. The Responsible Person is the company named on the label.
How Regovant can help
Regovant LLC registers cosmetic facilities under MoCRA, lists your products and acts as your U.S. Agent. Facility registration with U.S. Agent service is $369 per year, product listing is $269 per product and a cosmetic label review is $369 per product. See the cosmetics service, all guides or prices.