U.S. FDA Registration and U.S. Agent Requirements
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.
Food, Beverage and Supplement Labeling and Ingredients Review
Labeling errors are one of the leading causes of FDA detentions. ALN helps companies modify their food, beverage, or dietary supplement labeling to comply with FDA regulations. ALN provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, and other guidance documents.
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.
USDA Label Approval Requirements
Certain labels for meat and poultry products must be approved by the United States Department of Agriculture (USDA). ALN can conduct a full label review, determine if your label requires approval, and if so, submit it to USDA.
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.
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. ALN 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.
U.S. 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. ALN can properly petition to have your facility included on FDA’s Dairy List.
Certificate of U.S. FDA Registration
A Certificate of Registration issued by ALN serves as a third-party verification of your FDA food facility registration.