- OVERVIEW of FDA REGULATIONS -

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The United States Food and Drug Administration (FDA) is responsible for enforcing the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws which are designed to protect consumers' health, safety, and pocketbook. These laws apply equally to domestic and imported products. With the exception of most meat and poultry, all food and cosmetics as defined in the FD&C Act, are subject to examination by FDA when imported or offered for import into the United States. Food imported into the United States must meet the same laws and regulations as food produced in the United States. It must be safe and contain no prohibited ingredients, and all labeling and packaging must be informative and truthful, with the labeling information in English.

Imported food products are subject to FDA review when the food is offered for import at U.S. ports of entry. During the entry process, firms must provide to FDA information related to the specific products and the manufacturers of the products. Based on the entry information provided and other information FDA has, FDA will decide whether the product meets U.S. requirements and can be released into U.S. commerce. In the wake of various acts of terrorism, FDA exercises heightened vigilance in assessing food defense risk and maintaining the safety of the nation's food supply. Under provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which amended the FD&C Act, FDA established regulations requiring 01) that food facilities register with FDA and 02) the submission of prior notice of imported food.

 

- TABLE of CONTENTS​ -

  1. FDA Registration of Food Facilities

  2. Prior Notice oflmported Food Products

  3. Foreign Supplier Verification Program (FSVP)

  4. List of Food Safety Documents for FSVP

  5. Additional Useful Information & Links

 

- FDA REGISTRATION of FOOD FACILITIES -

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. Specifically, if FDA determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that: 01) Created, caused, or was otherwise responsible for such reasonable probability; or 02) Knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food.

Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA. To that end, kindly find several useful links below. The first will lead you to a general overview of the FDA's guidance concerning Registration of Food Facilities. The second contains a link-tree for Online Registration pages. The third is a step-by-step guide to Food Facility Registration.

01) Registration of Food Facilities

02) Online Registration of Food Facilities

03) Food Facility Registration User Guide: Step-by-Step Instructions