Food & Beverage Products and the FDA

FDA regulates all foods distributed in the U.S. in interstate commerce except for meat (beef, lamb, pork), poultry, eggs and products made from meat, poultry, and eggs, which are regulated by the U.S. Department of Agriculture and its agencies. All imported foods are already in interstate commerce when they reach the U.S. port of entry therefore, if your company exports food to the U.S., FDA will have jurisdiction over it when it arrives (and even before it arrives). FDA regulates foods for safety, adulteration (contamination), and proper labeling. FDAÕs jurisdiction is very extensive, reaching:

• fresh produce (fresh fruits & vegetables);
• processed foods (dry goods; from canned foods, prepared meals, etc.);
• dietary supplements and nutritional supplements;
• infant formulas;
• juices and carbonated drinks
• bottled water
• dairy products (cheeses, milk and milk products, yogurts, etc.);
• seafood products (fin fish, crustaceans, etc.);
• food ingredients (nutritional ingredients and non-nutritional ingredients),
• functional ingredients (emulsifiers, anti-caking agents, etc.)
• colors, flavors, spices, seasonings, vitamins added to food
• food contact surfaces (containers, utensils food manufacturing surfaces), and
• some alcoholic beverages (beer, wine)

Most foods do not require pre-approval before being sold in the U.S. Most also do not require product registration, although all food manufacturing, packing and holding (storage) facilities must be registered with FDA before their foods are distributed in the U.S. for consumption. The exceptions to these rules are low acid canned foods (LACF), acidified foods (AF), infant formulas, pasteurized grade A dairy products, food colors, food contact services and materials, and alcoholic beverages (although alcoholic beverages are permitted sale in the U.S. by the Bureau of Alcohol Tobacco and Firearms, Tax and Trade Bureau - TTB).

Some foods are called "standardized" foods - because FDA has established standards for them (for instance, various fruit preserves, mayonnaise, yogurts, and bottled waters). If a food is a standardized food, it must meet the standard established by FDA or the food will be considered adulterated and misbranded. Non standardized foods may not bear a standardized name. If the food meets a food standard then it must be called by its standardized name.

FDA does not pre-approve food labels either, however, the labels must be correct - that is, they must bear all the required information in the correct formats using the correct fonts and placements, and may not bear statements that are not permitted by FDA regulation. If they are not correct or they contain information that is not permitted, then the food is misbranded.

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 get 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 adulterated or misbranded foods are imported and FDA finds them. FDA will certainly take action. Therefore it is critical for food companies to make sure there foods and food labels comply with FDA requirements or they are likely to be stopped when they are imported by FDA. 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.

FDAImports.com consultants and affiliated attorneys represent hundreds of foreign and domestic food and beverage companies, providing critical regulatory guidance regarding food components, ingredients, quality, labeling, approvals and registrations. Call us to find out how we can assist your company.