Canada → US: Cosmetics U.S. Agent
Canada-based cosmetic facilities registered under the Modernization of Cosmetics Regulation Act (MoCRA) that export to the United States are required by FDA to designate a U.S. Agent. Assurentry provides fast, reliable U.S. Agent representation for companies in Canada.
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Why Canada Companies Need a U.S. Agent
Under U.S. federal law, every foreign facility that manufactures, processes, packs, or holds cosmetics for export to the United States must designate a person residing or maintaining a place of business in the U.S. as their agent.
For companies in Canada, this means appointing a U.S.-based representative who can receive FDA communications, assist with inspections, and act as your point of contact with the agency. Without a valid U.S. Agent, your FDA registration is incomplete and your products may be refused entry at U.S. ports.
Assurentry has extensive experience serving cosmetics companies from Canada and throughout the north america region. We understand the specific regulatory challenges your business faces and provide responsive, knowledgeable support.
What's Included for $399/year
MoCRA §607 — Cosmetics U.S. Agent Requirement
The FDA regulation MoCRA §607 requires all foreign cosmetics establishments to designate a U.S. Agent as part of their facility registration. Here is what that means for your Canada-based business.
Regulatory Authority
The U.S. Agent requirement is established under MoCRA §607 and enforced by the U.S. Food and Drug Administration (FDA). Compliance is mandatory for all foreign facilities in the cosmetics category.
Agent Responsibilities
Your U.S. Agent receives FDA communications on your behalf, assists with FDA inspections of your facility, helps respond to questions from FDA, and serves as an emergency point of contact for recalls or safety issues.
Consequences of Non-Compliance
Facilities without a valid U.S. Agent cannot complete their FDA registration. This can result in import refusals, shipment detentions at U.S. ports, FDA warning letters, and loss of market access.
Need help exporting cosmetics from Canada?
Our regulatory experts guide international companies through every step of FDA registration and U.S. Agent appointment.
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Appoint Assurentry as your U.S. Agent today for just $399 per year. We'll file the designation with FDA and provide your acceptance letter within one business day.
Trusted by 2,800+ companies in 160+ countries