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U.S. FDA Food and Beverage Regulations

Food and Beverages

The U.S. Food and Drug Administration (FDA) regulates food, beverages, and dietary supplements intended for consumption in the United States by humans or animals. Registrar Corp provides Registration, U.S. Agent, and Regulatory Compliance Assistance for U.S. and Non-U.S. Companies in the food, beverage, and dietary supplement industries.

FDA Registration and U.S. Agent Requirements (FDA Bioterrorism Act)

FDA registration is required for all facilities that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the United States by humans or animals. Companies located outside the United States must designate a U.S. Agent for FDA communications.

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Prior Notice (Sending Food and Beverages to the USA)

Prior Notice is required before food shipments may enter the United States. A bar-coded Prior Notice Confirmation Number issued by FDA must accompany most shipments.

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Food, Beverage and Supplement Labeling and Ingredients Review

Labeling errors are one of the leading causes of FDA detentions. Registrar Corp helps companies modify their food, beverage, or dietary supplement labeling to comply with FDA regulations. Registrar Corp provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents.

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USDA Label Approval Requirements

Certain labels for meat and poultry products must be approved by the United States Department of Agriculture (USDA). Registrar Corp can conduct a full label review, determine if your label requires approval, and if so, submit it to USDA.

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Food Canning Establishment (FCE) and Process Filings (SID)

Food Canning Establishment (FCE) registration and scheduled process filings (SIDs) are required for certain low-acid canned and acidified foods that may be consumed in the United States.

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FDA Food Safety Services

The Food Safety Modernization Act (FSMA) changed FDA food safety regulations. Registrar Corp provides Inspection, Hazard Analysis and Food Safety Planning, and Food Defense Planning assistance for companies in the food, beverage, and dietary supplement industries.

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Data Universal Numbering System (D-U-N-S®)

The Data Universal Numbering System (D-U-N-S®) is a business identification system operated by the private company Dun & Bradstreet®. Obtaining a D-U-N-S® number for your facility may help expedite your shipments to the United States.

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FDA Shell Egg Registration

Shell egg producers with 3,000 laying hens that do not sell all of their eggs directly to consumers must register with FDA. Registrar Corp can quickly and properly register shell egg producers with FDA.

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FDA Dairy List

To export milk products to China, Chile, or the EU, U.S. manufacturers and processors must be listed on the FDA Dairy List. Registrar Corp can properly petition to have your facility included on FDA’s Dairy List.

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Food Contact Substances (FCS)

Anything that touches food (or touches something that touches food) may be considered an Indirect Food Additive. FDA regulations regarding the use of indirect food additives are known as “Food Contact Substance” regulations.

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Food Color Additives and Food Color Batch Certification

A food color additive is any dye, pigment, or other substance that can impart color to a food product. Food color additives are regulated by FDA.

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Certificate of Registration Issued by Registrar Corp

A Certificate of Registration issued by Registrar Corp serves as a third-party verification of your FDA food facility registration.

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FDA Detention and DWPE Assistance

With the exception of most meat and poultry, food, beverages, and dietary supplements, are subject to examination by FDA when imported into the United States. Registrar Corp provides immediate assistance for companies with products detained at the port of entry by FDA, include those subject to DWPE due to an FDA Import Alert.

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Export Certificates of Free Sale

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an “Export Certificate” for products regulated by FDA. An Export Certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status.

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U.S. FDA Food Facility Registration Certificate

U.S. Food Facility Registration Certificate

FDA Registration and U.S. Agent Fees

‌US Food Facility Registration:$195 (Includes Certificate)
Non-US Food Facility Registration and U.S. Agent: $695 (Includes Certificate)
‌Certificate Only: $195

Prior Notice Fees

$19.95 per shipment

Discounts available for multiple shipments.

Labeling and Ingredient Review Fees

Labeling Review: $1,495 per product
Label Creation: $1,995 per product

Discounts available for multiple products.

Food Canning Establishment (FCE) and Process Filings (SID) Fees

FCE-SID Filing Service (First Year): $1,995
FCE-SID Filing Service (Annual Renewal): $995
FCE-SID Exclusion Certificate: $399 per product

Shell Egg Registration Fee

Shell Egg Registration: $195

FDA Dairy List Fee

Dairy List Petition: $1495

Certificate of Registration Fee

Certificate of FDA Registration: $195

Food Contact Substances (FCS) Fee

Food Contact Substance Review: $1,495 per product

Color Additive and Color Batch Certification Fees

Color Additive Report: $395 per color
Color Batch Certification Filing: $295 per batch

Data Universal Numbering System (DUNS)

Registrar Corp can obtain a Data Universal Numbering System
(DUNS) Number for your facility at no cost.

U.S. FDA Medical Device Establishment Registration Certificate

U.S. Food Facility Registration Certificate

FDA Registration and Listing Fees

FDA Device Establishment Registration: $150
Official Correspondent and U.S. Agent: $995 (Annual Fee)
Device Listings: $195 per product code

Labeling and Product Review Fees

Labeling or Product Review: $1,495 per product
Label Creation: $1,995 per product

Discounts available for multiple products.

Electronic Medical Device Reporting (eMDR) Fees

Registrar Corp submits adverse event reports for Official Correspondent and U.S. Agent Clients at no cost.

U.S. FDA Drug Establishment Registration Certificate

U.S. Food Facility Registration Certificate

Unique Device Identifier (UDI) Submission Fees

Single Submission: $95
Block of 10: $495 ($49.50 per submission)
Block of 25: $995 ($39.80 per submission)
Block of 50: $1,495 ($29.90 per submission)
Block of 100: $1,990 ($19.90 per submission)
Block of 500: $7,250 ($14.50 per submission)
Block of 1000: $9,950 ($9.95 per submission)

Medical Device Master File (MAF) Fees

MAF Submission: $1,495
MAF Agent for FDA Communications: $995 (Annual Fee)

Drug Master File (DMF) Fees

DMF Submission: $1,995
DMF Agent for FDA Communications: $995 (Annual Fee)

FDA Registration and Listing Fees

FDA Drug Establishment Registration: $845
Registrant Contact and U.S. Agent: $995 (Annual Fee)
Drug Listings: $645 per listing

Self-Identification Fee

Self-Identification Submission: $995

Registrar Corp submits self-identification information to FDA for Registrant Contact and U.S. Agent Clients at no cost.

Outsourcing Facility Fee

Registration and Registrant Contact: $2995

Export Certificate Fees

Export Certificate: $195

Radiation-Emitting Electronic Device Registration

Initial Product Report: $995
Annual Report: $495
Abbreviated Report: $995
Supplemental Report: $395
Agent for FDA Communications: $695

California Safe Cosmetics Act Certificate

Cosmetic Registration and Filing Fees

Cosmetic Registration: $395

Single Filing: $695
Block of 10: $3950 ($395 per filing)
Block of 25: $5,625 ($225 per filing)
Block of 50: $6,250 ($125 per filing)
Block of 100: $7,500 ($75 per filing)

Discounts available when filing with both
FDA and the State of California.

Cosmetic/Drug Registration Fee

Cosmetic/Drug Registration: $845
Registrant Contact and U.S. Agent: $995 (Annual Fee)
Cosmetic/Drug Listings: $645 per listing

Detention Assistance

Registrar Corp's fee for detention assistance is dependent on the cause of detention. Please call for a quote.

Fees for Food Safety Services

Food Safety Plan (First Product): $1995
Food Safety Plan (Additional Products): $995
HACCP Plan Review: $1995
HACCP Plan Creation: Contact Registrar Corp
Foreign Supplier Verification Program: $1995
Foreign Supplier Verification Program Agent: $195 per shipment
Voluntary Qualified Importer Program: Contact Registrar Corp
Food Defense Plan: $1995
Mock FDA Inspection: Contact Registrar Corp

Tobacco Registration and Listing Fees

Authorized Agent: $495
Tobacco Facility Registration: $195

Single Listing: $195
Block of 10: $1,750 ($175 per listing)
Block of 25: $3,750 ($150 per listing)
Block of 50: $6,250 ($125 per listing)
Block of 100: $9,500 ($95 per listing)


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