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.
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)
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. 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.
USDA Label Approval Requirements
U.S. FDA Food Canning Establishment (FCE) and Process Filings (SID)
U.S. FDA Food Safety Services
Data Universal Numbering System (D-U-N-S®)
U.S. FDA Shell Egg Registration
U.S. FDA Dairy List
U.S. FDA Food Contact Substances (FCS)
U.S. FDA Food Color Additives and Food Color Batch Certification
Certificate of U.S. FDA Registration Issued by Registrar Corp
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.
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.