{"product_id":"us-agent-for-cosmetic-facilities-12-months","title":"US Agent for Cosmetic Facilities (12 Months)","description":"\u003cp\u003eMoCRA requires every cosmetic facility outside the US to name a US agent in its FDA registration. Phoenix Safety Consultants LLC acts as your US agent for 12 months, is named in Cosmetics Direct, and receives and passes on FDA communications. The agent role does not make us your responsible person. £695 per facility per year.\u003c\/p\u003e\u003ch2\u003eWhat is a US agent for a cosmetic facility?\u003c\/h2\u003e\u003cp\u003eUnder \u003cstrong\u003eMoCRA\u003c\/strong\u003e and \u003cstrong\u003eFD\u0026amp;C Act section 607(b)\u003c\/strong\u003e, a cosmetic facility outside the US must name a \u003cstrong\u003eUS agent\u003c\/strong\u003e in its FDA registration. The US agent must live or have a place of business in the US and acts as a point of contact between \u003cstrong\u003eFDA\u003c\/strong\u003e and the foreign facility. \u003cstrong\u003ePhoenix Safety Consultants LLC\u003c\/strong\u003e provides this service. The US agent is different from the \u003cstrong\u003eresponsible person\u003c\/strong\u003e, whose name appears on the label.\u003c\/p\u003e\u003ch3\u003eWhat's included in your US agent service?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS agent designation\u003c\/strong\u003e: Phoenix Safety Consultants LLC named as US agent in your facility registration\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA communications\u003c\/strong\u003e: Receipt of FDA contact and prompt forwarding to you\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegistration entry\u003c\/strong\u003e: Agent details entered or updated in Cosmetics Direct\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAgent agreement\u003c\/strong\u003e: A written agreement setting out both sides' responsibilities\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e12 months of cover\u003c\/strong\u003e: Renewable each year\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this US agent service for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eUK, EU and other non-US cosmetic manufacturers and processors\u003c\/li\u003e\n\u003cli\u003eContract manufacturers supplying US brands\u003c\/li\u003e\n\u003cli\u003eFacilities registering under MoCRA for the first time\u003c\/li\u003e\n\u003cli\u003eFacilities replacing an existing US agent\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this US agent service not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eResponsible person duties.\u003c\/strong\u003e Being US agent does not make us the responsible person on your label; that is a separate service.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFacility registration.\u003c\/strong\u003e Available separately or in our Registration + US Agent package.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eProduct listings or adverse event reporting.\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLegal representation.\u003c\/strong\u003e The agent is a point of contact for FDA, not your lawyer.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does US Agent for Cosmetic Facilities work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eOrder and send details\u003c\/strong\u003e: Facility details and your registration number, if you have one.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAgreement\u003c\/strong\u003e: We send the US agent agreement to sign.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDesignation\u003c\/strong\u003e: We enter Phoenix Safety Consultants LLC as your US agent in Cosmetics Direct.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCover starts\u003c\/strong\u003e: We forward any FDA communications to you for 12 months.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch3\u003eWhat US law and FDA rules apply?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 607(b)\u003c\/strong\u003e — foreign facility registrations must include a US agent\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 607(a)\u003c\/strong\u003e — facility registration and biennial renewal\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 604\u003c\/strong\u003e — the responsible person is a separate role\u003c\/li\u003e\n\u003cli\u003eOfficial sources:\u003c\/li\u003e\n\u003cli\u003e[Modernization of Cosmetics Regulation Act of 2022 (FDA)](https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/modernization-cosmetics-regulation-act-2022-mocra)\u003c\/li\u003e\n\u003cli\u003e[Registration and Listing of Cosmetic Product Facilities and Products (FDA)](https:\/\/www.fda.gov\/cosmetics\/registration-listing-cosmetic-product-facilities-and-products)\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eRelated services\u003c\/h3\u003e\u003cp\u003eBrowse \u003ca href=\"\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/products\/mocra-cosmetic-facility-registration-with-fda\"\u003eMoCRA Cosmetic Facility Registration with FDA\u003c\/a\u003e, \u003ca href=\"\/products\/mocra-facility-registration-us-agent-first-year\"\u003eMoCRA Facility Registration + US Agent (First Year)\u003c\/a\u003e, \u003ca href=\"\/products\/us-responsible-person-for-cosmetics-12-months\"\u003eUS Responsible Person for Cosmetics (12 Months)\u003c\/a\u003e.\u003c\/p\u003e\u003cp\u003ePrepared by \u003cstrong\u003ePhoenix Compliance Services\u003c\/strong\u003e and reviewed by \u003cstrong\u003e\u003ca href=\"https:\/\/www.linkedin.com\/in\/shamuelshees\" rel=\"author\"\u003eSyed Muhammad Shamuel Shees\u003c\/a\u003e, US Regulatory Lead\u003c\/strong\u003e, with US agent and responsible person roles provided by Phoenix Safety Consultants LLC (USA), a sister company of Phoenix Compliance Services. FDA fees are not included and are passed through where they apply.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Default Title","offer_id":67824341319757,"sku":null,"price":695.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/us-agent-for-cosmetic-facilities-12-months.webp?v=1793176386","url":"https:\/\/phoenixcosmeticsafety.com\/products\/us-agent-for-cosmetic-facilities-12-months","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}