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Food & Beverages

FDA food regulations cover all foods and all beverages distributed in the U.S.A. except products that are regulated exclusively by the U.S. Department of Agriculture (USDA). USDA food regulations govern meat (beef, lamb, pork), poultry, eggs, and products made from meat, poultry, and/or eggs. All imported foods and beverages are considered to be in interstate commerce when they reach the U.S. port of entry. Therefore, if your company exports food or beverages to the U.S.A., FDA will have jurisdiction over the product when it arrives (and even before it arrives).

FDA’s food and beverage regulatory authority is very far-reaching, including provisions for domestic and imported food safety, food adulteration (contamination), and food labeling (misbranding).

FDAImports.com routinely works with food industry members to ensure imported products meet the requirements for FDA compliance.

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Some of FDA’s primary targets for regulatory enforcement:

Fresh produce (fruits and vegetables)

Pesticide residues, microbiological contamination

Processed foods (dry goods, canned foods,
acidified foods, prepared meals)

Microbiological contamination, food labeling requirements (such as nutrition labeling), submission of Scheduled Process documentation for canned foods

Dietary or nutritional supplements

Dietary ingredient safety, finished product safety, Supplement Facts labeling, permissible labeling and marketing claims

Infant formula

Conformity to FDA minimum nutrition requirements and labeling requirements

Fruit and vegetable juices, carbonated drinks,
and functional beverages (such as energy
drinks and antioxidant drinks)

Safe and permissible food additives, color additives, and ingredients; percent-juice declarations, labeling requirements

Bottled water

Conformity to FDA’s bottled water standards, chemical or microbiological contamination

Dairy products: cheeses, milk and milk products, yogurt

Standardized food requirements, specific FDA regulatory food standards

Seafood products (fin fish, crustaceans, etc)

Compliance with processing requirements (HACCP), microbiological contamination, decomposition and histamine production, antibiotics or other animal drugs

Food ingredients (nutritive and non-nutritive)

Generally Recognized as Safe (GRAS) status, appropriate intended uses and declaration in labeling

Special Regulatory Requirements

Registration/Listing: Most foods do not require FDA approval before being sold in the U.S. Most individual food items also do not require food registration or listing. However, all food establishments that manufacture, pack and hold (store) food are subject to FDA Food Facility Registration. FDA Food Facility Registration must occur before the imported foods arrive in the U.S. for human or animal consumption.

Pre-Market Review or Approval: Some food products are subject to special and additional regulations, including low acid canned foods (LACF), acidified foods (AF), infant formulas, pasteurized grade A dairy products, food colors, food contact surfaces and food contact materials, and alcoholic beverages (although alcoholic beverages are permitted for sale in the U.S. by the Alcohol and Tobacco Tax and Trade Bureau (TTB)). FDA regulates these imported foods differently by requiring some pre-market review or FDA approval prior to commercial distribution in the U.S.

Standardized Foods: Some foods are called “standardized foods” because FDA has established food standards for them, essentially creating an official recipe or definition for these foods. These additional requirements apply to a variety of foods, ranging from milk chocolate to salad dressings to yogurt and fruit preserves to bottled water. If a food is a standardized food, it must meet the standard established by FDA or it will be considered adulterated and misbranded. All foods are subject to specific food naming regulations, standardized foods and non-standardized foods alike.

Labeling Requirements: Food labels must be correct or the foods are misbranded under U.S. law. That is, the food labels must bear all the required information in the correct formats using the correct fonts and information placements, and food labels may not bear labeling claims or statements that are not permitted by FDA regulation.

CAUTION: If someone tells you that your food or its label must be pre-approved by FDA (other than the examples mentioned above) then they might be trying to induce you to pay for services that are not required. On the other hand, the fact that FDA does not pre-approve most foods or labels does not mean that FDA will be lenient when FDA finds adulterated or misbranded imported foods. FDA will certainly take action. Therefore, it is critical for food companies to make sure that their foods and food labels comply with FDA requirements, or they are likely to be stopped by FDA when they are imported. Fixing the problem at that stage is very expensive.

Need Help?

FDAImports.com, LLC shows you The Way Through. We represent hundreds of foreign and domestic food and beverage companies, providing FDA regulatory guidance regarding food components, ingredients, quality, labeling, approvals and registrations. Let FDAImports.com, LLC find The Way Through for you and your company. Get Started.

There are many specific requirements for many different foods that must be met before foods are imported into the U.S. Foods must be wholesome, unadulterated, properly labeled in all respects, come from FDA-registered manufacturers, packers and storage facilities, and, where required (which is rare), they must have the appropriate pre-approvals and product registrations.