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U.S. FDA Food, Beverage, and Dietary Supplement Regulations

The U.S. FDA regulates food, beverages, and dietary supplements intended for consumption in the United States by humans or other 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 Industry.  How to Export to the USA

U.S. FDA Registration & U.S. Agent Requirement (U.S. FDA Bioterrorism Act)
FDA Registration and U.S. Agent Requirement (Bioterrorism Act)
U.S. 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 U.S. FDA communications. For assistance with U.S. FDA Food Facility Registration regulations, simply click the Food Facility Certificate of Registration shown on the left.  Food Facility Registration Data
Prior Notice Express (Sending Food and Beverages to the USA)
Prior Notice Express (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 U.S. FDA must accompany most shipments. To quickly file Prior Notice by Fax or Online, simply click the Prior Notice Confirmation document shown on the left.
Food Canning Establishment (FCE) and Process Filings (SID) FCE-SID Examples
FCE (Food Canning Establishment) and Process Filings (SID)
Food Canning Establishment (FCE) registration and scheduled process filings (SIDs) are required for low-acid and acidified foods that may be consumed in the United States. To determine if U.S. FDA FCE-SID regulations are applicable to your products or to receive assistance with your FCE-SID filings, simply click on the FCE-SID Certificate shown on the left.
Food, Beverage & Supplement Labeling and Ingredients Review
Label and Ingredient Reviews
Labeling mistakes result in more than 22% of all detentions in the United States. Registrar Corp helps companies modify their food, beverage, or dietary supplement labeling to comply with U.S. 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. To learn how U.S. FDA food, beverage, and dietary supplement labeling regulations apply to your products, simply click the Notice of FDA Action shown on the left.
Food Contact Substances (FCS)
Label and Ingredient Reviews
Anything that touches food (or touches something that touches food) may be considered an Indirect Food Additive. The U.S. FDA regulations regarding the use of indirect food additives are known as "Food Contact Substance" regulations. To determine if U.S. FDA's Food Contact Substance regulations are applicable to your products, simply click the Notice of FDA Action shown on the left.
Food Color Additives and Food Color Batch Certification
Color Additive Notice of FDA Action
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 the U.S. FDA. To determine how U.S. FDA's food color additive regulations apply to your food products, simply click the Notice of FDA Action shown on the left.
U.S. FDA Food Safety Services
Color Additive Notice of FDA Action
The Food Safety Modernization Act (FSMA) changed U.S. 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 Import Assistance (FDA Detentions/FDA Import Alerts)
Detention Without Physical Examination Assistance
With the exception of most meat and poultry, food, beverages, dietary supplements, drugs, biologics, cosmetics, medical devices, and electronic products are subject to examination by U.S. FDA when imported into the United States. Registrar Corp's team of Regulatory Specialists provides immediate assistance for companies with products detained at the port of entry by U.S. FDA.

U.S. FDA Regulations:

U.S. FDA Food Facility Registration: 21 C.F.R. sections 1.225 - 1.243

U.S. FDA Prior Notice: 21 C.F.R. sections 1.276-1.285

U.S. FDA FCE/SID: 21 C.F.R. sections 108, 109, 113, 114

U.S. FDA Food Labeling: 21 C.F.R. Part 101 et seq.

U.S. FDA Color Additives: 21 C.F.R. Parts 73, 74, and 80

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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