Axentra Pricing: Published Fees for FDA and Health Canada Filings
Flat, published fees for foreign food, supplement, pet food and cosmetic brands. You see the price and what it covers before you call us.
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No setup fee
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2-year price lock on U.S. Agent
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Not FDA or Health Canada fees
Service
Price
U.S. FDA Agent + Food Facility Registration (food, pet food, dietary supplements)
$249 per facility per year
FDA cosmetics (MoCRA): U.S. Agent + cosmetics facility registration
$249 per facility per year
Cosmetic product listing, new or material change
$49 per listing
Cosmetic listing yearly renewal, no material change
$29 per listing update
Cosmetic label review
$49 per SKU
FSVP Agent
$349 per year
FSVP Qualified Individual (up to 3 suppliers)
$549 per year
Prior Notice filing
Flat $25 per filing, or 10 filings for $200
Import detention handling
$499 per case (one FDA detention notice)
Pet food / treat label review
$130 per SKU, or $69 per SKU for 10+ SKUs
Dietary supplement label review
$49 per SKU
Food label review (non-supplement)
$49 per SKU
Health Canada Cosmetic Notification (CNF)
USD 99 per notification, or USD 69 each for 5+
Canadian label review
USD 29 per label with CNF filing; without CNF, USD 49 per label or USD 29 each for 5+
Canadian representative and Canadian address
USD 419 per year
All prices are in U.S. dollars. None of them is a government fee.
U.S. FDA Agent + Food Facility Registration: $249 per facility per year
For foreign facilities that make, process, pack or hold food (including pet food) or dietary supplements for the United States. One flat fee per facility, locked for 2 years. No setup fee and no rush fee. Cosmetics facilities are covered at the same rate (see FDA cosmetics, below).
Included
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Axentra designated as your facility's U.S. Agent, FDA's U.S. contact for the facility
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Receiving and relaying FDA communications to you as your U.S. Agent
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A new Food Facility Registration (FFR) filing, or your biennial renewal while your subscription is active
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Registration updates during the year when your facility details change
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Taking over as U.S. Agent from your current agent, including when you no longer have your registration PIN
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Help getting a DUNS number when your registration needs one
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Prior Notice guidance for your shipments (Axentra filing a Prior Notice is $25, below)
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Filing within 1–2 business days after complete information
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2-year price lock, no setup fee and no rush fee
Not included
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FDA fees: none apply. FDA charges no food facility registration fee (21 CFR 1.231(c)).
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Prior Notice filing by Axentra ($25 per filing, below)
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Detention handling beyond receiving and relaying FDA notices ($499 per case, below)
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FSVP Agent or FSVP Qualified Individual services (below)
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Form FDA 2541 process filing (acidified and low-acid canned foods) and TTB work
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Label review (priced per SKU, below), plus state feed registrations and fees for pet food
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Drug, OTC and device registration and listing work
Renewal if you are not a subscriber. Biennial renewal is included only while your subscription is active. If your registration has lapsed and you are not a subscriber, renewal or re-registration starts with the $249 subscription.
Registration is not FDA approval of your facility or your products.
Read more: FDA food facility registration · U.S. Agent services
FDA cosmetics (MoCRA): product listing, label review and facility registration
Product listing and label review are standalone services. You can order them without a U.S. Agent subscription.
Item
Price
Product listing in Cosmetics Direct, new listing or material change
$49 per listing
Yearly listing renewal update, no material change
$29 per listing update
Listing update, contact or address details only
No charge
Label, artwork and claims review
$49 per SKU
U.S. Agent and cosmetics facility registration, for a foreign facility
$249 per facility per year (2-year lock)
What the law covers. Under MoCRA, section 607 of the FD&C Act (21 U.S.C. 364c), a person who owns or operates a facility that manufactures or processes cosmetic products for U.S. distribution registers that facility with FDA. A foreign facility's registration includes the name and contact details of its U.S. agent. The responsible person lists each cosmetic product, and listings are updated every year. Certain small businesses are exempt from registration and listing under section 612, except for some product types. We confirm which duties apply to you before we start.
Product listing and label review
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New listing or material change, such as a new formula or product name: $49 per listing, with INCI ingredient declaration review included
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Yearly listing renewal update with no material change: $29 per listing update
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Listing updates that change only contact or address details: no charge
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Label, artwork and claims review for U.S. requirements, with written comments: $49 per SKU
Not included
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OTC drug registration and listing, including sunscreens and products with drug claims (quoted by class)
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Serious adverse event (cosmetovigilance) work (quoted per project)
U.S. Agent and facility registration: $249 per facility per year
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Axentra designated as the U.S. agent named in your foreign facility's registration
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Preparing and submitting your facility registration in FDA's Cosmetics Direct
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Filing within 1–2 business days after complete information
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2-year price lock, no setup fee and no rush fee
Registration and listing are not FDA approval of your facility or your products.
Read more: MoCRA cosmetic listing and U.S. labels
FSVP Agent: $349 per year
Support for the Foreign Supplier Verification Program (FSVP), priced separately from U.S. Agent (FFR) service.
Included
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Axentra named as the U.S. contact for FDA communications about your FSVP records. Axentra is not your FSVP importer; that role and its FSVP duties stay with the importer.
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Receiving FDA communications about your FSVP, such as document requests and inspection notices, and relaying them to you within 1 business day
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Aligning the agent details on your entry filings
Not included
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Acting as your FSVP importer
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U.S. Agent (FFR) service, which is the $249 fee above
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FSVP Qualified Individual work: hazard analysis and supplier verification ($549, below)
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Customs entries, bonds or customs broker work. The customs importer of record is a separate CBP role, and Axentra doesn't provide it.
FSVP Qualified Individual: $549 per year, up to 3 suppliers
A qualified individual for your FSVP. FDA's FSVP rule (21 CFR 1.503) requires certain FSVP activities to be carried out by a qualified individual, and that person may be outsourced.
Included
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A qualified individual who develops and applies your FSVP under 21 CFR part 1, subpart L
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Hazard analysis for the foods you import
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Supplier verification activities, with complete records
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Up to 3 suppliers
Not included
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Additional suppliers beyond 3 (quoted separately)
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On-site supplier audits (quoted separately)
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Customs importer of record, bond or broker services
Prior Notice filing: flat $25 per filing, or 10 filings for $200
FDA must receive Prior Notice before food imported or offered for import arrives in the United States (21 CFR part 1, subpart I).
Included
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Axentra filing your Prior Notice through FDA's Prior Notice System Interface (PNSI) or ABI
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Confirmation details sent to you and your customs broker before arrival
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Prior Notice guidance with your U.S. Agent service
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Flat $25 per filing, with no rush fee
Not included
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Customs entry, customs bond or customs broker services
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Prior Notice for drug or other non-food shipments (quoted)
Import detention handling: $499 per case
For a shipment FDA detains at entry. Your U.S. Agent fee already covers receiving and relaying FDA's notices. This fee covers handling the case beyond that. One case is one FDA detention notice.
Included
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Assessing the case: labeling, registration, Prior Notice, FSVP and other issues FDA raises
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Preparing the written response or submission to FDA
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Coordinating with your importer and customs broker through release or FDA's final decision
Not included
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Third-party costs, such as FDA re-examination fees, storage, re-labeling labor and testing. You pay these at cost, and Axentra coordinates them.
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Legal representation. Axentra is not a law firm.
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Import-alert removal petitions (quoted case by case)
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Any guarantee of release. FDA decides every detention.
Pet food and treat label review: $130 per SKU, or $69 per SKU for 10 or more
For U.S. pet food, treats and pet supplements, which U.S. law treats as animal food.
Included
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Formulation review: U.S. animal-food status of each ingredient, which claims each ingredient can support, and ingredients to confirm or change before the label is locked
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A U.S. label format sample for your designer, panel by panel, using your product's real amounts
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A claims "Do" and "Don't" list for every panel, your website, inserts, social media and marketplace listings
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Compliance review of your finished artwork against FDA animal-food labeling rules (21 CFR Part 501), with written comments
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Re-checks of minor revisions to the same label at no extra charge
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Readiness notes for state feed registration, import (food facility registration, Prior Notice, FSVP) and shelf life
Not included
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State feed registration filings and state fees
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USDA APHIS permit applications
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Stability, palatability or laboratory testing
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U.S. Agent, facility registration and FSVP (priced above)
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Trademark filings, additional SKUs, or new label versions beyond minor revisions
This review is not an approval by FDA, USDA, any state or any marketplace. FDA does not pre-approve pet food labels.
Read more: pet food registration and U.S. Agent
Dietary supplement label review: $49 per SKU
For human dietary supplements sold in the United States.
Included
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Supplement Facts panel review
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Ingredient list review
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Allergen and other required label statements
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Claims wording
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One round of re-review after you make the changes
Not included
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New dietary ingredient (NDI) notifications
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Structure/function claim notifications to FDA
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Laboratory testing or formula substantiation
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U.S. Agent and facility registration ($249, above)
Label review is not FDA approval. FDA does not approve dietary supplement labels before sale.
Read more: dietary supplement FDA compliance
Food label review: $49 per SKU
For human foods sold in the United States, other than dietary supplements. Pet food has its own review, above.
Included
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Nutrition Facts panel review
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Ingredient list review
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Allergen and other required label statements
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Claims wording
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One round of re-review after you make the changes
Not included
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Laboratory testing or nutrient analysis
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Form FDA 2541 process filing (acidified and low-acid canned foods)
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U.S. Agent and food facility registration ($249, above)
Label review is not FDA approval. FDA does not approve food labels before sale.
Read more: U.S. FDA labeling compliance · FDA food facility registration
Health Canada Cosmetic Notification (CNF): USD 99, or USD 69 each for 5 or more
For foreign beauty brands selling cosmetics in Canada. Health Canada requires a Cosmetic Notification Form within 10 days after a cosmetic is first sold in Canada (Cosmetic Regulations, s.30).
Item
Price
CNF filing
USD 99 per CNF, or USD 69 per CNF when you file 5 or more
Canadian label review, bought with CNF filing
USD 29 per label
Canadian label review, without a CNF
USD 49 per label, or USD 29 per label for 5 or more
Canadian representative and Canadian address
USD 419 per year
Other work
Quoted separately, only with your prior written approval
One CNF for shades. Products with the same base formula that differ only in shade, scent or flavour go on one CNF, listed under "Other product names" (Health Canada, Guide for Cosmetic Notifications). Products with different base formulas need separate CNFs.
Canadian representative and address. You need this only when no Canadian importer or other party in Canada will be named on the CNF. Since 5 March 2025 the notification needs a Canadian address for the manufacturer or importer (Health Canada, Guide for Cosmetic Notifications, Section 4).
Included in CNF filing
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Confirming each product is a cosmetic, not a Natural Health Product or drug, before filing
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Preparing and submitting the CNF to Health Canada
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Listing shade, scent and flavour variants of an unchanged base formula on the same CNF
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Filing within 1–2 business days after complete information
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Amendments Health Canada requests on a CNF that Axentra filed, at no extra charge
Not included
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Reformulations: work on a changed formula is billed as a new CNF (USD 99, or USD 69 each for 5 or more)
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Other work is quoted separately, only with your prior written approval.
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Natural Health Product, drug and food (CFIA) matters
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Health Canada fees: none apply. Health Canada says there is no fee for the cosmetic notification process.
A CNF is a notification, not a Health Canada approval.
Read more: Canada cosmetics Responsible Person and CNF
Quoted by class
OTC drugs and sunscreens, drug establishment registration and listing, APIs, medical devices, eCTD dossiers and cosmetovigilance projects are quoted by product class. We confirm the scope in writing before any work starts.
How our pricing works
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Turnaround: filing within 1–2 business days after complete information. FDA and Health Canada processing times are outside our control.
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No surprises: any work outside a listed scope is quoted, and starts only after you approve it in writing.
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Government fees: the fees on this page are Axentra's service fees. FDA charges no food facility registration fee, and Health Canada charges no fee for cosmetic notifications.
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Not approval: registration, listing and notification are not FDA or Health Canada approval. Axentra provides regulatory consulting, not legal advice.
Frequently asked questions
How much does Axentra's U.S. FDA Agent service cost?
$249 per facility per year for food, pet food, dietary supplement and cosmetics facilities. The price is locked for 2 years, with no setup fee and no rush fee.
What is included in the $249 U.S. Agent fee for food facilities?
Axentra is designated as your facility's U.S. Agent and receives and relays FDA communications to you. The fee also covers a new Food Facility Registration (FFR) filing or your biennial renewal while your subscription is active, registration updates during the year, taking over from your current U.S. Agent (including when you no longer have your PIN), help getting a DUNS number when needed, and Prior Notice guidance. Filing is within 1–2 business days after complete information. Prior Notice filing, detention handling, FSVP services and label review are priced separately.
Is the $249 an FDA fee?
No. It is Axentra's service fee. FDA charges no fee for food facility registration (21 CFR 1.231(c)).
Do you charge a setup fee or a takeover fee?
No. There is no setup fee and no rush fee, and taking over as your U.S. Agent from another provider is included in the $249 per facility per year.
What do FDA cosmetics listing, label review and registration cost?
Cosmetics product listing and label review are standalone services, so you can order them without a U.S. Agent subscription. Product listing in FDA's Cosmetics Direct is $49 for a new listing or for a material change such as a new formula or product name, with INCI ingredient declaration review included. A yearly listing renewal update with no material change is $29 per listing update, and updates that change only contact or address details are free. Label, artwork and claims review is $49 per SKU. For a foreign cosmetics facility, Axentra as the U.S. agent named in your facility registration, plus the facility registration in Cosmetics Direct, is $249 per facility per year, locked for 2 years.
What is the difference between the FSVP Agent and FSVP Qualified Individual fees?
They are two separate services. FSVP Agent is $349 per year: Axentra is named as the U.S. contact for FDA communications about your FSVP records, relays those communications to you within 1 business day, and aligns the agent details on your entry filings. Axentra does not act as your FSVP importer. FSVP Qualified Individual is $549 per year: a qualified individual develops and applies your FSVP, including hazard analysis and supplier verification, for up to 3 suppliers. Additional suppliers and on-site audits are quoted separately. Neither is the same as U.S. Agent (FFR) service, which is $249 per facility per year.
How much does Prior Notice filing cost?
Axentra files Prior Notice at a flat $25 per filing, with no rush fee, or 10 filings for $200. We send the confirmation details to you and your customs broker before arrival. Prior Notice guidance is included with our U.S. Agent service.
What does it cost if FDA detains my shipment?
Your U.S. Agent fee covers receiving and relaying FDA's notices to you. Full detention handling is $499 per case, where one case is one FDA detention notice. It covers the case assessment, a written response to FDA, and coordination with your importer and customs broker through release or FDA's final decision. Third-party costs, such as FDA re-examination fees, storage, re-labeling labor and testing, are not included. FDA decides every detention.
How much is a pet food or treat label review?
$130 per SKU, or $69 per SKU when you have 10 or more pet SKUs. It covers a formulation review, a U.S. label format sample, a claims Do and Don't list, an artwork review against 21 CFR Part 501, minor revisions and readiness notes. State feed registrations and fees, USDA APHIS permits and testing are not included.
How much is a food or dietary supplement label review?
They are two separate services at $49 per SKU each. Food label review, for human foods other than dietary supplements, covers the Nutrition Facts panel, the ingredient list, allergen and other required label statements, and claims wording, with one round of re-review after you make the changes. Dietary supplement label review covers the same points with the Supplement Facts panel in place of Nutrition Facts. Laboratory testing is not included, and label review is not FDA approval.
How much does Health Canada cosmetic notification (CNF) support cost?
CNF filing is USD 99 for a single CNF, or USD 69 per CNF when you file 5 or more. Shades, scents or flavours of the same base formula go on one CNF. Amendments Health Canada requests on a CNF that Axentra filed are free; work on a changed formula is billed as a new CNF. Canadian label review is USD 29 per label with CNF filing. Without a CNF, it is USD 49 per label, or USD 29 per label when you have 5 or more labels reviewed. A Canadian representative and Canadian address is USD 419 per year, needed only when no Canadian importer or other party in Canada will be named on the CNF. Other work is quoted separately, only with your prior written approval. Health Canada charges no fee for cosmetic notifications.
What is the difference between a U.S. Agent and an FSVP importer?
The U.S. Agent is FDA's U.S. contact for your facility registration. The FSVP importer is the party responsible for verifying its foreign suppliers under FDA's FSVP rule, usually the U.S. owner or consignee of the food at entry. They are different roles under different rules.
How fast is the turnaround?
We file within 1–2 business days after complete information. FDA and Health Canada processing times are outside our control.
Is FDA registration or a Health Canada notification an approval?
No. Registration, listing and notification are not FDA or Health Canada approval of your facility or products. Axentra provides regulatory consulting, not legal advice.
Official sources
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21 CFR 1.227 and 1.231: Food facility registration definitions, U.S. Agent and "No registration fee is required" (eCFR). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H
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FDA: Registration of Food Facilities and Other Submissions. https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions
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FDA: Is It Really "FDA Approved"? https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
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FD&C Act section 607, cosmetic facility registration and product listing (21 U.S.C. 364c). https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section364c&num=0&edition=prelim
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FDA: Registration and Listing of Cosmetic Product Facilities and Products. https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products
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FDA: FSVP regulation, 21 CFR part 1, subpart L. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-L
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FDA: Prior Notice of Imported Foods. https://www.fda.gov/industry/fda-import-process/prior-notice-imported-foods
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21 CFR Part 501, animal food labeling (eCFR). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-E/part-501
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Health Canada: Notification of cosmetics. https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics.html
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Health Canada: Guide for Cosmetic Notifications. https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics/guide.html
Talk to Axentra
Tell us your products, your facility country and your target market. We confirm which fees apply, then send a written scope.
Axentra Global Pharma Compliance LLC
1209 Mountain Road Pl NE, STE 7912
Albuquerque, NM 87110
+1-505-358-4858 · info@axentracompliance.com