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FDA Food Requirements

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FDA Food Requirements (Including Dietary Supplements)

FDA defines foods as articles used for food or drink for man or other animal, chewing gum, and articles used for components of any such article.

FDA has begun enforcing several new food safety regulations under the Food Safety Modernization Act and the Bioterrorism Act and has significantly increased its surveillance of imported food shipments in order to ensure the US food supply is safe. To market food products in the US, companies should ensure the following requirements are met:

Facility Registration

All non-exempt facilities that process, prepare, pack, or hold the food for US consumption must be registered as food facilities with FDA and each facility receives a unique registration number. Food facility registrations must be renewed every even-numbered year e.g. 2020, 2022, 2024, etc.

US Agent for Foreign Facilities

A registered facility in a foreign country must have a US agent. The US agent must be located in the US and receive communications from FDA and assist FDA with scheduling inspections of the foreign facility.

Foreign Supplier Verification Program (FSVP)

Unless exempted by law, imported foods must have an FSVP. The entity responsible for maintaining FSVP records and making them available for FDA inspection must be in the US and must have a Data Universal Numbering System (DUNS) number.  For more information on FSVPs, click here.

Low-acid canned Food (LACF) and Acidified Food

For a low-acid canned food (LACF) and an acidified food, the processing facility must be registered as a food canning establishment with FDA. This is separate from the food facility registration mentioned above.  FDA assigns a food canning establishment (FCE) number to the facility. Note that LACF foods are not necessarily contained in “cans”. LACF foods may be contained in sealed bottles, cardboard boxes, jars, and other hermitically sealed e.g. airtight containers.  Also, each LACF or acidified food must have a scheduled process filed with FDA to assure FDA the product is free of the deadly pathogen, Clostridium botulinum. When a scheduled process is filed with FDA, a Submission Identifier (SID) number is assigned to that food.

Prior Notice

To import food shipments, prior notice must be submitted for each shipment unless exempted by law.  Prior notice is used by FDA to screen imported food shipments for any possible tampering or intentional adulteration of the goods. Prior Notice consists of information that is similar to the basic entry information submitted by the import filer/broker to Customs and FDA when the shipments make entry.  The main difference is that Prior Notice must be electronically transmitted to FDA prior to the goods arriving at the port of arrival.

The timeframe required for transmitting Prior Notice depends on the mode of delivery i.e. air, ocean, truck, or rail. Anyone with knowledge of the information required to be submitted in the Prior Notice may submit the Prior Notice to FDA. The Customs broker often submits the prior notice, so ask your broker if they offer this service.  Those who are not licensed Customs brokers may use FDA’s online Prior Notice System Interface (PNSI) which can be found out:

https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Importing/ucm2006836.htm

Label Requirements

Ensure the product label complies with all federal labeling requirements such as having a properly declared statement of identity, net quantity of contents (net weight), nutrition facts (conventional foods), supplement facts (dietary supplements), ingredient list with names of each ingredient properly declared, any required allergen source declarations, business name and address (manufacturer, distributor, or packer), country of origin, and other labeling requirements. Remember, the label is the first thing the FDA sees when they physically examine your shipments!

Ingredient Check

  • Be sure that all food additives in the food are legally allowed to be in the food. Food additives are basically any substances added to the food. In order to be in the food, a food additive must be approved by FDA or be generally recognized as safe (GRAS) by qualified experts for the intended use.
  • Each batch or lot of color additive that requires certification must be certified by FDA.
  • For products containing meat or poultry, verify whether the Animal and Plant Health Inspection Service (APHIS) allows the type of meat or poultry in your product to be imported and whether the shipment must be accompanied by a Veterinary Services permit. Permit requirements depend on the type of meat or poultry, the country of origin, and other factors.
  • If USDA regulates the product, the ingredient must meet the requirements of the Food Safety and Inspection Service (FSIS) which includes certification of the foreign establishments that process, slaughter, store, or perform other operations on the food.
  • Determine if the food contains any ingredients subject to Bovine Spongiform Encephalopathy (BSE) restrictions.
  • For fruit and vegetable products or products containing fruit or vegetable ingredients, determine if the United States Department of Agriculture (USDA) allows that type of fruit or vegetable to be imported. This primarily depends on the country of origin.
  • Ensure none of the product’s ingredients are prohibited by US Fish and Wildlife due to being derived from an endangered species or if the ingredient requires a Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) permit for importing an endangered species.

Hazard Analysis and Risk-Based Preventive Controls

Facilities (including foreign facilities) that manufacture, process, pack, or store food for consumption in the US must have a food safety system that includes comprehensive, science and risk-based preventive controls that minimize the risk of known or reasonably foreseeable food safety hazards. Facilities that comply with the seafood or juice Hazard Analysis and Critical Control Point (HACCP) rule are exempt from this rule.  There are exemptions or partial exemptions to this rule for certain other foods as well.

Good Manufacturing Practices

The foods must be processed in accordance to FDA’s Good Manufacturing Practice (GMP) regulations. The GMPs cover requirements for methods, equipment, facilities, and controls used to process food to ensure the food is processed under safe and sanitary conditions. 

Claims are Truthful and Not Misleading

The Federal Trade Commission (“FTC”) has jurisdiction over product advertising and therefore may also take regulatory action against products for any false, misleading claims, and unsubstantiated claims.

Seafood and Juice Products

FDA requires importers of juice and importers of seafood products to maintain records verifying that the processing facility(s) complies with the Hazard Analysis and Critical Control Point (HACCP) regulations.

Pre-market Testing

Though not mandatory, food importers may wish to have a private laboratory test for contaminants known to be associated with the food e.g. Salmonella, pathogenic E. coli, illegal pesticides, heavy metals, filth, etc.

Foods Labeled as Organic

Any organic labeling must meet USDA’s organic labeling and certification requirements.

California Proposition 65

For products marketed in California (including packaging), Proposition 65 requires businesses to provide warnings to the consumers about any substances in the products that California believes causes cancer or reproductive harm including birth defects. California lists these substances in its “Prop 65 list” ( https://oehha.ca.gov/proposition-65/proposition-65-list). If the products contain any of those listed substances, companies can usually meet the Prop 65 requirements by placing the appropriate warning statement on the product’s label.

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Richard Chiang worked for the FDA for 13 years beginning as a field investigator and entry reviewer and later worked at the FDA’s headquarters Center for Food Safety and Applied Nutrition (CFSAN)

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