Food & Beverages

FDA food regulations reach all foods and all beverages distributed in interstate commerce in the U.S.A. except for 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 eggs.

All imported foods and imported beverages (including juices) are already 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 food regulations and FDA beverage regulations cover domestic and imported food safety, food adulteration (contamination), and food labeling (misbranding). FDA’s food regulatory authority is very far-reaching, and includes:

  • fresh produce (fresh fruits and vegetables), usually concerned with pesticide residues or microbiological contamination;
  • processed foods (dry goods, canned foods, acidified foods, prepared meals, etc.), usually interested in microbiological contamination, insect, bird, rodent or other animal filth, submission of scheduled process documentation for canned foods, and all food labeling requirements, such as Nutrition Labeling in foods and beverages;
  • dietary supplements and nutritional supplements, related to dietary ingredient and finished product safety, Dietary Supplement Facts labeling, and other permissible dietary supplement labeling and marketing claims;
  • infant formulas, with respect to conformity to FDA minimum nutrition requirements and product labeling requirements;
  • fruit and vegetable juices, carbonated drinks, and functional beverages (such as energy drinks and antioxidant drinks), usually considering safe and permissible food additives and ingredients, safe color additives, percent-juice declarations, juice labeling requirements and Nutrition Facts labeling for all types of beverages and drink products;
  • bottled water, related to conformity to FDA’s regulatory bottled water standards, chemical contamination and microbiological contamination;
  • dairy products (cheeses, milk and milk products, yogurts, etc.), many of which are standardized foods and must meet specific FDA regulatory food standards;
  • seafood products (fin fish, crustaceans, etc.), usually for compliance with processing requirements (HACCP, or Hazard Analysis and Critical Control Point regulations), microbiological contamination, decomposition (and histamine production), and anti-biotic or other animal drug use in aquaculture seafood;
  • food ingredients (nutritive ingredients and non-nutritive ingredients), with respect to generally recognized as safe (GRAS) status,
  • functional food ingredients (emulsifiers, anti-caking agents, etc.), related to appropriate intended uses and declaration in food label ingredient declarations
  • food color additives, natural flavors and artificial flavors, spices, seasonings, and vitamins added to food
  • food contact surfaces (containers, utensils, food manufacturing surfaces, beverage containers and food containers), and
  • some alcoholic beverages (beer, wine)

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.

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 imported foods differently by requiring some pre-market review or FDA approval prior to importing food for commercial distribution in the U.S.

Some foods are called “standardized foods” because FDA has established food standards for them. These additional requirements apply to a variety of foods, ranging from milk chocolate to salad dressings; and yogurt and fruit preserves to bottled water. Most foods, however, are non-standardized foods. If a food is a standardized food, it must meet the standard established by FDA or the food will be considered adulterated and misbranded. All foods are subject to specific food naming regulations, and that applies to standardized foods and non-standardized foods alike.

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.

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.

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