Food & Beverages
How Are Food and Beverages Regulated?
The Food and Drug Administration (FDA) regulates all foods and beverages distributed in the United States except products that are regulated exclusively by the US Department of Agriculture (USDA). USDA food regulations govern meat (beef, lamb, pork), poultry, eggs, and products made from them. FDA has jurisdiction over all imported foods and beverages upon, and even before, their arrival in the US. FDA regulations concern food safety, adulteration (contamination), processing, labeling (misbranding), facility registration, prior notice, and ingredients.
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|
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.
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 US 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 US.
Canned foods (low acid canned foods, or LACF products, and acidified food canned food products) are subject to special FDA permit controls, which are implemented through FDA Food Canning Establishment (FCE) regulations and FDA Scheduled Process Identification (SID) filings. These regulations apply in addition to those for all foods. Any low acid canned food processor, which is required to submit an FDA FCE registration must also submit to FDA a scheduled process filing form. Before importation canned food manufacturer’s Scheduled Process must be reviewed by FDA’s Center for Food Safety and Applied Nutrition (CFSAN), including the manufacturer’s aseptic or acidification processes for producing commercially sterile low-acid canned foods or properly acidified food and eliminating the risk of botulism poisoning in the food product. Modifications in the manufacturing process, container type, acidulators, or aseptic processing equipment requires submission of updated SID forms.
There are other important food manufacturing details that are required in order to obtain proper SID Number compliance. At FDAImports we assist low acid canned food and acidified food processors to acquire a SID Number and to comply with all FDA regulations related to Scheduled Process updates, including reducing the number of filings of related products and processes.
FDA has issued specific processing regulations (good manufacturing practices or GMP regulations) governing seafood products and juices, called FDA Hazard Analysis and Critical Control Point (HACCP) regulations. There are specific HACCP regulations that apply to US seafood importers and juice importers. These HACCP regulations are in addition to those for all foods. FDAImports has former HACCP inspectors with the know-how to ensure seafood and juice processors, manufacturers and importers meet their HACCP requirements including preparing HACCP plans.
Organic products are increasingly popular. Businesses hoping to market their products as organic in the US must be properly certified by the USDA’s National Organic Program (NOP). Only products that comply with the NOP’s standards of production may use the term organic. Read more about organic food here.
USDA uses the National Bioengineered Food Disclosure Standard (NBFDS) to determine whether a product is a bioengineered (BE) food and how it must be disclosed. BE food is defined as food containing genetic material modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques that cannot be found in nature or through conventional breeding. USDA, not FDA, has regulatory authority over voluntary labeling of BE content in human foods (the NBFDS does not apply to animal food). FDA has jurisdiction over labeling statements indicating the absence of BE content.
Products that unintentionally contain, or have technically unavoidable BE presence of up to five percent per ingredient are exempt, but this exemption does not apply when using a highly refined bioengineered food ingredient that is not refined to the point where detectable modified genetic material is no longer present. Foods certified under NOP is exempt because BE ingredients are not permitted at all. Foods regulated by USDA under the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), or the Egg Products Inspection Act (EPIA) are only subject to the disclosure requirement when the finished food product’s most predominant ingredients are FDA-regulated. In effect, the rule exempts meat, poultry, and eggs, along with products where meat, poultry, and eggs are the main ingredients. Because of the overlapping nature of USDA and FDA jurisdiction, even agency employees can be confused.
BE content can be disclosed with text, a symbol, electronic or digital link, and/or text message. Small food manufacturers or small packages may also use a phone number or web address.
- For bioengineered foods with 85% or more adoption rate in the US (Bioengineered food highly adopted), declare “Bioengineered food,” or “Contains a bioengineered food ingredient,”
- For bioengineered foods with less than 85% adoption rate in the US (Bioengineered food not highly adopted), there are other options, such as “may be a bioengineered food” or “may contain a bioengineered food ingredient.”
- Symbol: The AMS has published these symbols
- Digital Link (such as a QR code): Including a statement to direct consumers to scan the product for more food information.
There is sometimes uncertainty regarding what DNA related techniques fall under the definition of BE food. While UDSA maintains a list of commonly BE foods, companies can choose to petition AMS for a determination on whether a product is considered as BE food. Making such a determination can ensure labeling compliance. AMS also has limited enforcement power; they can audit records and take complaints. Labeling of BE food under the NBFDS is currently voluntary but will become mandatory on January 1, 2022.
As food research and technology advances, new food ingredients are often introduced into food manufacturing and the US food supply. However, food additives may only be used in conventional foods if they are Generally Recognized as Safe (GRAS), if they are the subject of a food additive regulation, or if they are “prior sanctioned” additives (food ingredients that have been used safely in the food supply prior to January 1, 1958). Food additives achieve GRAS status in two primary ways.
- The manufacturer “self-affirms” the GRAS status of the ingredient by maintaining documentary evidence of the safety of the ingredient, including its derivation, processing, and the effects of its consumption under specified intended uses.
- The manufacturer can submit a GRAS Notification filing to FDA, containing similar documentation. FDA does not determine the GRAS status of the food additive, instead, FDA decides whether to object or not.
Many US finished food manufacturers will only purchase food ingredients or food additives if they have, at a minimum, an FDA “No Objection” letter to a GRAS Notification. Without FDA documentation, the manufacturer must maintain documentary evidence that the particular ingredient or food additive is GRAS.
Although FDA does not require manufacturers to submit GRAS self-assessments, the agency could disagree with a manufacturer and take regulatory action against a food containing a food additive that FDA believes it can prove is not GRAS. Because of FDA’s increased authority over imported foods, it is important for foreign food additive and ingredient manufacturers to have evidence regarding the GRAS status of these products. Foods containing additives, which are not GRAS, are considered adulterated and are subject to detentions, import alerts, and refusal of admission. In addition, importing adulterated food may subject the manufacturer or importer to administrative and criminal penalties.
FDA strictly regulates color additives for use in foods, drugs, cosmetics, and medical devices. All color additives for use in cosmetics must have specific FDA approval for their intended cosmetic applications. FDA requires that color additives receive either batch certification or an exemption from certification. All color additives must be approved, safe, declared on labels, or the product containing them will be considered misbranded and possibly adulterated. Some color additives are used commonly outside the US but are still not permitted in the US. Manufacturers may use different color formulations for different markets, however, if a parallel importer purchases a food, beverage, drug, or cosmetic manufactured for a non-US market and diverts it into the US, FDA may discover this and take action against the manufacturer. Using illegal or non-permitted color additives can result in detentions, import alerts, and refusal. It is important that foods, beverages, dietary supplements, drugs, and cosmetics declare all color additives in the product label’s Ingredients Statement.
FDA has a specific Import Alert for foods and beverages from foreign manufacturers and shippers that have been found to contain illegal food color additives and non-permitted beverage colors. Being removed from such an alert requires reformulating the product. Because each shipment must be tested to prove it does not contain an unapproved color additive, import alerts can be very expensive.
Pet food is food or drink for animals, including cat or dog food, treats, or snacks, and products like horse feed. While FDA does not require pre-market approval for pet food, it does require pet food to be safe to eat with no harmful food additives or colors and be truthfully labeled. Animal supplements have no federal definition, though FDA’s Center for Veterinary Medicine has used an informal process for dealing with pet supplements, in many cases states regulate them as pet foods with all the standard requirements.
Under the Food Safety Modernization Act (FSMA) the Foreign Supplier Verification Program (FSVP) requires pet food importers to have a program to verify that imported pet food and the foreign supplier comply with US law. If FDA determines an importer’s FSVP plan is inadequate, they can stop their shipments, even if the pet food is safe and compliant. Pet foods are also required to follow Current Good Manufacturing Practices (cGMPs) minimum standards for established sanitary conditions for animal food production facilities, and manufacturers are subject to hazard analysis and preventive control requirements (HARPC).
Pet food, as a conventional food under the Federal Food, Drug and Cosmetic Act (FFDCA), requires its facilities to register with FDA. Foreign manufacturers must also register and appoint a US Agent. Importers, manufacturers, and distributors of pet food must also register with each state they sell in. Typically, this is done with the state’s feed control office, though each state has its own process, requirements, and fees.
FDA requires animal feed labels to include a statement of identity, net quantity statement, name and address declaration, and ingredient list. States have their own labeling requirements, usually requiring guaranteed analysis and a nutritional adequacy statement. The Association of American Feed Control Officials (AAFCO) published a set of model rules, which most states have adopted. USDA requires that importers have a Veterinary Service Permit (“VS Permit”) and/or a Plant Protection and Quarantine Permit (“PPQ Permit”) before receiving products containing certain animal- or plant-origin materials, to prevent the spread of disease.
Failure to obtain the proper permit, certifications, register facilities, or correctly label products can lead to import detention, Import Alerts, and refusal.
Federal law requires food labels to bear specific information in the specific formats using the specific fonts and information placements; food labels are also restricted in what claims or statements they can make. While FDA does not pre-approve labels, they are not lenient with mislabeled or misbranded foods. FDA has jurisdiction over all food labels, except meat, dairy, and egg products. FDA requires food labels to contain a statement of identity, net quantity, ingredients, Nutrition Facts, allergen risks, and food label claims.
FDA regulations also permit nutrient content claims, structure or function claims, and health claims, under strictly regulated conditions. Health claims characterize the relationship between a substance and a health-related condition (e.g., “A diet low in sodium may reduce high blood pressure.”). Nutrient Content Claims characterize the level of a nutrient in food (e.g., “Good source of protein.”). Structure or function claims describe how a food or beverage affects the structure or function of the body (e.g., “Supports healthy blood circulation.”).
Most food labels and beverage labels must contain Nutrition Facts declarations that conform to very specific requirements related to formatting, nutrient names and amounts, and Percent Daily Value calculations. In 2016 FDA updated the Nutrition Facts panel’s Daily Values for some nutrients, labeling of caloric content, “Serving size” for many foods, including “added sugars” as a subcategory of “total sugars,” and replacing the requirement to include Vitamins C and A with Vitamin D and potassium. These rules are currently in effect, except for manufacturers with less than $10 million in annual food sales who have until January 1, 2021.
Food labeling online is regulated by both FDA and the Federal Trade Commission (FTC), with FDA limiting the types of permissible claims more than FTC. FTC regulates all food advertising claims under a “truthful and not misleading” standard. In addition, both FDA and FTC law require that all claims be substantiated by adequate scientific evidence.
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 at the border. Fixing the problem at that stage is very expensive. Read more about labeling your products here..
Registration & Listing
Most foods do not require FDA approval, registration, or listing to be sold in the US. However, all food establishments that manufacture, pack and hold (store) food are subject to FDA Food Facility Registration before arrival in the US. This requirement applies to foreign food manufacturers and exporters of conventional foods, beverages, dietary supplements and food additives and ingredients. FDA will issue import refusals for an imported food or imported beverage manufactured by a foreign facility that is not registered.
The Food Safety Modernization Act (FSMA) changes require a biennial (every other year) registration renewal for all food facilities. Additionally, all changes or modifications to the required information must be included by way of food registration updates submitted to FDA. Prior Notice must be filed with FDA and US Customs and Border Protection (CBP) including the Food Facility Registration Number of every foreign manufacturer of imported food or imported beverages before arriving in the US. FDA food facility registration is free, and FDA does not require a certificate of registration for any purpose, even import. We have a convenient registration portal where you can submit all the information necessary for registering your food facility, modifying your registration, requesting an official FDAImports registration certificate, and more. Read further about registration and listing requirements here.
Food Canning Establishment (FCE) Registration
All low acid canned food (LACF) and acidified canned food manufacturers must submit a Food Canning Establishment (FCE) Registration with FDA before exporting to or distributing canned foods in the United States. The FDA FCE Registration is in addition to the standard food registration requirement. When the FCE Registration is submitted to FDA, the manufacturer must also submit to FDA its Scheduled Process filings for all of its commercially sterile, acidified and low-acid canned foods to obtain a Scheduled Process Identification (SID) Number from FDA for each specific canned food and aseptic or acidified food process.
Although only canned food manufacturers and processors are required to obtain an FCE Number for their facility and SID Numbers for their scheduled processes, US importers, wholesalers, distributors, and brokers must ensure their suppliers have correctly filed their Scheduled Processes and that the food they are importing is actually subject to the SID Number. Failing to take into account the accuracy and applicability of the FCE and SID information can result in very expensive FDA import detentions and FDA import refusals that cannot be overcome by simply filing some paperwork after the fact or by correcting some labeling violations. FDA will refuse admission to any imported LACF or acidified food or beverage processed by a manufacturer lacking the required FCE Number and SID Numbers.
Foreign food manufacturers and foreign beverage manufacturers that are subject to FDA Food Facility Registration requirements must also appoint a US Agent for FDA purposes. This agent acts as FDA’s primary point of contact for the foreign food or beverage manufacturer as it relates to the foreign food facility. Please note, this is not the same as an FSVP Agent, who has substantially different duties. US Agent information is submitted electronically through FDA’s electronic systems during the food facility registration process. Each foreign establishment may designate only one US Agent. The foreign food facility may also designate its US Agent as its official correspondent.
The US Agent may be called upon to speak to the FDA for the foreign registered manufacturer, packer or storage facility. Therefore, it is critical that the US Agent understands the FDA regulations that govern the imported food or imported beverage and the manufacturing process regulations that the foreign manufacturer must follow.
Many US Agency services sell US Agency and facility registration services, primarily, and resell annual services. Although they may also perform some rudimentary regulatory reviews, many lack substantive experience in FDA law, FDA regulations, and FDA enforcement actions. You are required to select a US Agent to comply with US law and FDA regulation. We believe you should select a US Agent that is also capable of providing comprehensive regulatory compliance services that ensure your imported foods comply with all FDA requirements and are successfully imported, marketed, and distributed in the United States.
We at FDAImports represent many foreign and domestic food manufacturers, importers, marketers, and distributors of all sizes and in all genres. We make clear the way through FDA and USDA regulations and requirements to help our client’s import and sell their food and beverage products in the United States. We review labels, deal with FDA detentions and refusals (including Import Alerts), deal with FDA inspections, and register our clients with FDA and USDA. Please contact us today with any questions or concerns you may about getting your food or beverage compliant.