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

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.

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) 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.

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.

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.

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.

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.

Companies shipping products to the United States may find their shipments subject to "Detention Without Physical Examination" by U.S. FDA. Products subject to detention without physical examination are held at the port of entry while U.S. FDA performs additional scrutiny, testing, and analysis. Delays from detention without physical examination may be lengthy for businesses anxious to deliver products on schedule. For assistance with a detention, simply click on the Notice of Action shown on the left.