MoCRA requires every cosmetic product marketed in the U.S. to have a designated Responsible Person: the manufacturer, packer, or distributor whose name appears on the product label, accountable for the product’s compliance with FDA requirements. Unlike the U.S. Agent role, Responsible Person status can’t be outsourced; it’s fixed to whoever is named on the label. For foreign brands, we support your RP compliance work, safety records, SAE reporting, and recall coordination, as your U.S. Agent and compliance partner.
Responsible Person Services
We support your Responsible Person obligations under MoCRA: maintaining product safety records, managing adverse event reports, and coordinating ongoing FDA compliance, working alongside your designated RP rather than replacing it.
- Product safety record maintenance
- Serious Adverse Event (SAE) reporting
- FDA communication management
Serious Adverse Event Reporting
Under MoCRA, the Responsible Person must report Serious Adverse Events (SAEs) to the FDA within 15 business days. We manage this critical compliance obligation.
- SAE intake & review process
- 15-business-day FDA submission
- Medical terminology assessment
- Follow-up report management
Product Safety Records
MoCRA requires the Responsible Person to maintain adequate safety records for each cosmetic product. We help establish and maintain compliant product safety documentation.
- Safety record documentation setup
- Ingredient safety data management
- Product safety substantiation
- Records maintenance & retention
FDA Recall & Mandatory Recall Support
MoCRA granted the FDA mandatory recall authority for cosmetics. As Responsible Person, we coordinate recall communications and FDA response on your behalf.
- Mandatory recall response coordination
- Voluntary recall support
- FDA communication management
- Consumer notification coordination
Need Responsible Person Help? Register Now:
Need help meeting your Responsible Person obligations? If you’re a foreign cosmetic brand, we support RP compliance, safety records, SAE reporting, and recall coordination, as your U.S. Agent and compliance partner.
Responsible Person Designation FAQs
Yes. The Responsible Person can be located anywhere in the world; it’s determined by whose name appears on the product label, not by location. The catch is that a foreign Responsible Person must also designate a U.S. Agent for FDA communications, which is a separate requirement.
The Responsible Person is accountable for the product itself: safety substantiation, adverse event reporting, and overall FDA compliance. The U.S. Agent is the FDA’s point of contact for communications with a foreign facility. They’re distinct roles under MoCRA, and one company or person can serve both functions, but they aren’t interchangeable.
The product is considered misbranded under MoCRA and cannot legally be marketed or distributed in the U.S., exposing the company to FDA enforcement action.
Within 15 business days of the Responsible Person becoming aware of them. Records related to these reports must be kept for 6 years, or 3 years for small businesses.
Not in the way we can serve as your U.S. Agent. Under MoCRA, the Responsible Person is fixed to whoever is named as manufacturer, packer, or distributor on the product label; that role can’t be outsourced to a third party the way it can in the EU. FDA Entry supports your RP compliance work and can act as your U.S. Agent, but your business remains the legal Responsible Person.