Administration Center for Food Safety And Applied Nutrition

Public Health Service Food and Drug

April 9, 2011 This is in response to your inquiry to the Food and Drug Administration (FDA) concerning how to market a food product. Not all of the information below may apply to your particular product type. GENERAL REQUIREMENTS OF FEDERAL LAW - Under provisions of the U.S. Federal Food, Drug and Cosmetic Act, food manufacturers, processors and distributors marketing food products are charged with the legal responsibility of ensuring that their products intended for distribution in U.S. interstate commerce are safe, sanitary, and labeled according to federal requirements. FDA is not authorized under the law to approve, certify, license or otherwise sanction individual food products, manufacturers, processors, labels, imports, importers or distributors. Manufacturers and distributors are free to produce and distribute food products in U.S. commerce without prior sanction from this agency. However, in so doing, they assume the responsibility for assuring that the products meet the laws and regulations administered by the FDA. FDA can take various steps to remove unsafe or mislabeled foods from the marketplace. FACILITY REGISTRATION - The U.S. Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Act) require that food facilities (other than private homes) producing, storing or handling food products intended for sale in U.S. interstate commerce be registered with FDA. Registration of facilities can be performed on the internet, and is free of charge. For information and instructions on how to register a facility, please see FDA’s web page on the subject at the following link: FACILITY RECORDKEEPING: The Act also contains food facility recordkeeping requirements. On December 9, 2004, FDA issued a final rule that requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food. The final rule implements Section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (See 69 FR 71562; December 9, 2004, ( ). The rule states persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States are subject to the regulations in part 1 (21 CFR part 1) subpart J of this final rule (i.e., recordkeeping and access requirements). You can access common questions and answers on

importers or distributors. ACTION LEVELS FOR POISONOUS AND DELETERIOUS SUBSTANCES Also.establishment and maintenance of records at the following link: http://www. or otherwise be unfit for food. The GMP regulations are contained in Part 110 of Title 21 of the U.fda. The FDA Action Levels for Poisonous and Deleterious Substances can be accessed at this link to the FDA website: http://www. FDA has guidance regarding action levels for certain food commodities and a number of poisonous and deleterious substances.In addition to the facility-registration and recordkeeping.S.Manufacturers and distributors should be aware that FDA has issued defect action levels (DALs) for some food commodities for natural and unavoidable defects such as mold.cfm?CFRPart=110.S.fda.-Processors of food products sold in U.S. packed. ALLERGEN GUIDANCE .The Food Drug &Cosmetics Act requires that foods sold in U. regulations sets forth basic considerations manufacturers and distributors should take into account to keep food clean and safe during efenseandEmergencyResponse/ucm062801.-Manufacturers are not required to provide any sort of test results to the FDA as a condition of producing.S. These documents are available at these links to the FDA website: SAFETY AND SANITATION . This set of U.fda. marketing or distributing food products.htm. Code of Federal Regulations.htm and at http://www.fda. nor does FDA accepts samples of food products offered for testing by manufacturers. packing and or rendered injurious to health. Under the . putrid. or held under unsanitary condition whereby the products become contaminated with filth.fda. or the presence of pesticides prohibited in foods or amounts of allowable pesticides in excess of established tolerances. (Examples include evidence of rodent or insect or decomposed substances.htm. FDA’s DAL list can be accessed at this link to the FDA website: http://www. Full information about FDA’s implementation of these requirements is available at this link: http://www.htm. commerce not bear or contain any poisonous or deleterious substances which may render them injurious to health. Like the DALs for natural and unavoidable defects. ADMINISTRATIVE DETENTION .accessdata. This guidance document identifies tolerance amounts of these defects in shipments of these products. these action levels establish for the listed commodities the maximum allowable amounts of the listed substances. commerce should be familiar with and employ the U.Food manufacturers should be aware that FDA has issued compliance policy and inspection guidance about food allergens. nor consist in whole or in part of any calContaminantsandPesticides/ucm077969. FOOD MANUFACTURING. insect filth and mammalian excreta. They can be accessed at the following web link to Title 21 provisions: http://www. DEFECT ACTION LEVELS . Current Good Manufacturing Practices for foods (GMPs).gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Sanitati on/ucm056174.) Foods must not be prepared. the Act grated the FDA new administrative detention powers.fda.

. Please note that the FDA does not test food products on behalf of or as a service to regulated firms. and in most cases nutritional information. Please note that FALCPA does not address the use of advisory labeling.In 2004 the U. the net weight of contents in both English and metric ulatoryInformation/ abelingNutrition/ abelingNutrition/ucm063113. RETAIL LABELING. labeling requirements can be obtained from FDA’s web page on the subject at the web address http://www. the name and address or phone number of the responsible firm (may be the manufacturer or including statements describing the potential presence of unintentional ingredients in food products resulting from the food manufacturing process.fda. Department of Agriculture’s food nutrient database to determine if the database provides information from which they can derive the appropriate nutrient information for their products.S. Further links at this new URL http://www. regulations on food labeling. Manufactures can also examine the U. Smaller manufacturers may qualify for exemption from the requirement for nutrition labeling. Fair Labeling and Packaging Act. Such laboratories can be located through Yellow-Page listings for major metropolitan areas under the listing “laboratories. Detailed information about U.nal. The agency has not and does not intend to prescribe how an individual company is to determine nutrient content for labeling purposes.S. which provides technical instructions to manufacturers about how to develop and use nutrition databases for food products. Congress passed legislation requiring more explicit listing of allergenic ingredients on the labels of retail food products. FDA has issued guidance addressing the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) available at this web link: http://www.requirements of U. The database can be accessed at this link: http://www.S.usda. manufacturers may choose to employ the services of a commercial laboratory equipped to perform analyses of foods to determine nutrient connect a number of guidance on food labeling and nutrition topics.htm . foreign or domestic).fda. a list of ingredients in descending order or predominance in the product. FDA has developed its own Nutrition Labeling Manual. For developing nutrition The manual is available at this new URL: http://www. food law.Provisions of the FD&C Act. 2006. The section on the left titled Food Labeling Guidance & Regulatory Information connects to the U. This information is required to be presented in a format that ensures that the information is accessible to consumers under normal conditions of purchase and use.fda. The law went into effect January 1.S. Here at this link you will find FDA’s “A Food Labeling Guide. INCLUDING NUTRITION LABELING . the U.” which was prepared to assist manufacturers in preparing labels that meet the regulatory requirements.htm.S. ALLERGENS IN INGREDIENT STATEMENTS . interstate commerce bear labels in English (Spanish acceptable in Puerto Rico) that include specific information: the identity of the product.” through internet search-engine searches of appropriate terms. manufacturers and distributors are expected to take necessary and reasonable steps to ensure the safety and sanitation of their food products. and through advertisements in food trade journals. and the Nutrition Labeling and Education Act require that retail packages and containers of food products sold in U.

For purpose of registration and process filing an LACF product must meet all of these requirements:  is a thermally processed product and  packed in a hermetically (air tight) sealed container and  with an acid content above pH 4. If the product meets the above definitions the processing facility must be registered as a lowacid or acidified facility and the manufacturer must file processing information for each LACF or AF product produced that is intended for export to the US. It has a water activity greater than 0.htm. FDA has also published answers to questions concerning registration and process filing requirements as well as an instructional booklet that you should read.all commercial processors of low-acid and acidified foods located in the United States and all processors in other countries who export lowacid canned food or acidified food products into the United States must register their processing plants with FDA.fda.S. Detailed information—including contact information—is available in FDA’s “food” page.85 and is stored and distributed under non-refrigerated conditions.85 and  that receives a heat treatment to achieve commercial sterility and  normally stored and distributed under non-refrigerated conditions. These standards establish minimum ingredient requirements for the covered foods. a LACF/AF facility and as a food facility under the Bioterrorism act. Here’s the link: http://www. distributors. in the Food Safety section under the “Acidified & Low-Acid Canned Foods” heading.fda.STANDARDS OF IDENTITY . Note that processors of low-acid and acidified food that export such products to the US must register as both. brokers. . LOW ACID CANNED AND ACIDIFIED FOODS .htm. The standards for foods are contained in Parts 130 – 169 of Title 21 of the U.6 or below.cfm.Under authority of the FD&C Act. FDA must have on file the process or processes filed for the foods and FDA must also receive prior notice of each food shipment. Furthermore. Such products are called "acidified foods (AF)".accessdata. if your food is a low acid/acidified product two separate registration requirements apply and such firms must register under both authorities.fda. Please refer to FDA’s new web page on low acid/acidified canned foods at http://www. are not required to register and file processes. etc. Some processors "acidify" their low-acid canned food products by adding acidic ingredients in order to inhibit microbial growth. An acidified food is a low-acid food to which acid(s) or acid food(s) are added for the purpose of reducing the pH to a finished equilibrium pH of 4. Code of Federal Regulations: http://www. FDA has promulgated “standards of identity” for a number of food product categories. and if applicable.6 and  containing enough water ("water activity) greater than 0. In other words. importers. they must ensure that processing firms they represent comply with all registration and process filing requirements. which must be met in order for the food legally to be sold bearing the statement of identity covered by the standard. BOTTLED WATER PRODUCTS – In addition to the other applicable requirements listed here. Local. Market Withdrawals and Safety Alerts. training and pathogen material is available at this link to the FDA website: http://www. Code of Federal Regulations: http://www. The direct web link to the topics is http://www.fda. HACCP REQUIREMENT FOR JUICE PRODUCTS – In addition to the other applicable requirements listed here. HACCP REQUIREMENT FOR SEAFOOD PRODUCTS – In addition to the other applicable requirements listed here.fda.S.htm. These are contained in Part 129 of Title 21.htm.fda. These are contained in Part 165 of Title 21. To sign up. ORA offices are located throughout the country. special requirements apply to bottled water products. You can access these regulations from this new food safety/bottled water product web link http://www. please select the topics that interest you. FDA’s security and defense guidance can be accessed at this link to the FDA website: efault. processors.fda.cfm?CFRPart=114. the agency has published guidance on the hazards associated with fish and fishery products and appropriate controls for those most juice products are required to have been processed in a facility that has in place an operational Hazard Analysis and Critical Control Point (HACCP) safety plan.htm. In addition. Make sure to check FDA has promulgated a separate set of GMPs specifically for water bottling plants.fda. regional and district offices can be found in the Blue Pages . FDA FIELD OFFICES AND INSPECTIONS .fda. FDA has promulgated regulations that stipulate definitions for various terms that may appear on the retail labels of bottled water products.accessdata. and transporters should be aware that FDA has issued food-security guidance designed to protect their operations against the potential for bioterrorism.Inspections of FDA-regulated facilities are carried out by inspectors with FDA’s Office of Regulatory Affairs. FDA requires processors of fish and fishery products to develop and implement HACCP systems for their operations and to assist them.htm STAYING INFORMED – FDA offers a number of free e-mail alert services allowing interested parties to receive important FDA news and information as it becomes federal regulations imposing the requirements for LACF and AF foods are contained in Parts 113 and 114 of Title 21 of the U. seafood products are required to have been processed in a facility that has in place a written and operational Hazard Analysis and Critical control Point (HACCP) safety plan. FOOD SECURITY – Food manufacturers. Consolidated information about HACCP seafood requirements is available at this new FDA web link: http://www. Local FDA/ORA office can also be a point of contact for manufacturers and distributors located within that jurisdiction.htm. The guidance is available at this FDA web page: d/FishandFisheriesProductsHazardsandControlsGuide/default.accessdata. Information about the HACCP requirement for juice products. or wherever you come across the envelope icon on FDA Web pages.

gov/Food_Safety_Education/USDA_Meat_&_Poultry_Hotline/index. if any. FSIS can be reached at 1-800-233-3935. and through FDA’s Investigations Operations efault.S. Sincerely. STATE REQUIREMENTS . • FDA's Laboratory Manual is available at this new Field Science link http://www. are regulated by the U. available at this new agency web link http://www. State food-regulatory contacts can be located at this new web link http://www. Currently. RESOURCES: SCIENCE/TESTING METHODS • The Food and Drug Administration's "Bacteriological Analytical Manual" contains the agency's preferred laboratory procedures for microbiological analyses of foods. individual firms or facilities can not request an FDA inspection. Defense and Emergency Response . or by email at FSIS. frozen casseroles and pizzas.Regulations@usda.of local telephone BIBLIOGRAPHY. available at this new web link: or at the following link: http://originwww.htm.htm#Foods • MEAT AND POULTY PRODUCTS – Meat and may apply to their operations. In general. Department of Agriculture’s Food Safety and Inspection Service.asp .fda.htm Determining when and what FDA-regulated facilities are inspected is the prerogative of FDA staff.fda. for examples. they may be required to obtain licenses and inspections at the state and/or local levels. Jeannine Acklin Consumer Affairs Specialist Communication and Coordination Branch Office of Food Safety.fda. It is available at this new food web link lBAM/ while they face no FDA licensing requirements. and combination products such as. containing 3 percent or more meat by weight.usda. FDA recommends that all new food manufacturers check with their state’s foodregulatory office to determine what licensing and inspection requirements.htm FDA's Food Regulatory Compliance Manual Methods. FDA focuses its inspection resources on those categories of industry and products with the greatest potential for safety problems.Food manufacturers should be aware that.htm • • The methods published by the Association of Official Analytical Chemists (AOAC INTERNATIONAL Homepage) Pesticide Analytical Manual (PAM) available at this new web link http://www.

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