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.
U.S. 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.
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.
Registrar Corp’s Food Safety Specialists are Preventive Controls Qualified Individuals (PCQIs) and can develop or review your business’ Hazard Analysis and Risk-based Preventive Controls (HARPC) Plan, Foreign Supplier Verification Program (FSVP), and Food Defense Plans. In addition, our specialists can conduct Onsite FSVP Food Safety Audits and FSMA Readiness Audits.
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. FACT inc. 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.
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.
U.S. FDA 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.
U.S. 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.
U.S. 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.
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.
U.S. FDA 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.
Certificate of U.S. FDA 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.
The Kosher food industry is a lucrative and growing market around the world. Registrar Corp has developed a synergetic partnership with Star-K to provide companies with Kosher Certification for their food and beverage products.
U.S. FDA 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.
U.S. State Bottled Water Requirements
Many U.S. states require licensing, certification, or additional labeling statements for bottled water sold in their jurisdiction in additon to FDA regulations. Registrar Corp offers reports that explain the different requirements for each state.
U.S. 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.
U.S. FDA Export Listing Module (ELM)
U.S. exporters must be on an FDA export list in order to ship dairy, infant formula, collagen, gelatin, or seafood products to certain countries. Registrar Corp can properly petition to have your facility included on an FDA export list through FDA’s Export Listing Module.
Export Certificates to Foreign Governments
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.