The United States Food and Drug Administration (FDA) regulates all food and food-related products, except commercially processed egg products, and meat and poultry product, including combination products (e.g., stew, pizza), containing two percent or more poultry or poultry products, or three percent or more red meat or red meat products which are regulated by the United States Department of Agriculture's Food Safety and Inspection Service (FSIS). Fruits, vegetables and other plants are regulated by the that Department's Animal and Plant Health Inspection Service (APHIS) to prevent the introduction of plant diseases and pests into the United States. The voluntary grading of fruits and vegetables is carried out by the Agricultural Marketing Service (AMS) of the USDA.
All nonalcoholic beverages, and wine beverages containing less than 7% alcohol, are the responsibility of FDA. All alcoholic beverages, except wine beverages (i.e., fermented fruit juices) containing less than 7% alcohol, are regulated by the Bureau of Alcohol, Tobacco and Firearms of the Department of Treasury.
In addition, the Environmental Protection Agency (EPA) regulates pesticides. EPA determines the safety of pesticide products, sets tolerance levels for pesticide residues in food under a Section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and it publishes directions for the safe use of pesticides. It is the responsibility of FDA to enforce the tolerances established by EPA
Within the United States, compliance with the FD&C Act is secured through periodic inspections of facilities and products, analysis of samples, educational activities, and legal proceedings. A number of regulatory procedures or actions are available to FDA to enforce the FD&C Act, and thus help protect the public's health, safety and well-being.
Adulterated or misbranded food products may be voluntarily destroyed or recalled from the market by the shipper, or may be seized by U.S. Marshals on orders obtained by FDA from Federal district courts. Persons or firms responsible for violation may be prosecuted in the Federal courts and if found guilty may be fined and/or imprisoned. Continued violations may be prohibited by Federal court injunctions. The violation of an injunction is punishable as contempt of court. Any or all types of regulatory procedures may be employed, depending upon the circumstances.
A recall may be voluntarily initiated by the manufacturer or shipper of the food commodity, or at the request of FDA. Special provisions on recalls of infant formulas are in the FD&C Act. While the cooperation of the producer or shipper with FDA in a recall may make court proceedings unnecessary, it does not relieve the person or firm from liability for violations.
It is the responsibility of the owner of the food in interstate commerce to ensure that the article complies with the provisions of the FD&C Act, the Fair Packaging and Labeling Act (FPLA), and their implementing regulations. In general, these Acts require that the food product be a safe, clean wholesome product and its labeling be honest and informative.
The FD&C Act gives FDA the authority to establish and impose reasonable sanitation standards on the production of food. The enclosed copy of Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110) contains the current Good Manufacturing Practice (GMP) regulations for manufacturing, packing and holding human food concerning personnel, buildings and facilities, equipment, and product process controls which, if scrupulously followed, may give manufacturers some assurance that their food is safe and sanitary. In 21 CFR 110.110, FDA recognizes that it is not possible to grow, harvest, and process crops that are totally free of natural defects. Therefore, the Agency has published the Food Defect Action Levels. These defect action levels are set on the basis of no hazard to health. In the absence of a defect action level, regulatory decisions concerning defects are made on a case by case basis.
The alternative to establishing natural defect levels in food would be to insist on increased utilization of chemical substances to control insects, rodents and other natural contaminants. FDA has published "action levels" for poisonous or deleterious substances to control levels of contaminants in human food and animal feed. However, a court in the United States invalidated FDA's "action levels" for poisonous or deleterious substances on procedural grounds. In the interim we are using Action levels for Poisonous or deleterious Substances in Human Food and Animal Feed as guidelines which do not have the "force and effect" of law. The Agency has made it clear that action levels are procedural guidelines rather than substantive rules.
FDA does not approve, license, or issue permits for domestic products shipped in interstate commerce. However, all commercial processors, whether foreign or domestic, of thermally processed low-acid canned foods (LACF) packaged in hermetically sealed containers, or of acidified foods (AF) are required by regulations to register each processing plant. In addition, each process for a LACF or AF must be submitted to FDA and accepted for filing by FDA before the product can be distributed in interstate commerce.
A low-acid food is defined as any food, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85 - many canned food products are LACF products and packers are, therefore, subject to the registration and processing filing requirements. The only exceptions are tomatoes and tomato products having a finished equilibrium pH less than 4.7. An acidified food is a low-acid food to which acid(s) or acid food(s) are added resulting in a product having a finished equilibrium pH of 4.6 or below.
FDA' s LACF regulations require that each hermetically sealed container of a low-acid processed food shall be marked with an identifying code that shall be permanently visible to the naked eye. The required identification shall identify, in code, the establishment where the product is packed, the product contained therein, the year and day of the pack, and the period during the day when the product was packed (21 CFR 113.60(c)) . There is no requirement that a product be shipped from the United States within a stipulated period of time from the date of manufacture. If a LACF or AF is properly processed, it would not require any special shipping or storage conditions.
Our regulations require that scheduled processes for LACF shall be established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers and having adequate facilities for making such determinations (21 CFR 113.83). All factors critical to the process are required to be specified by the processing authority in the scheduled process. The processor of the food is required to control all critical factors within the limits specified in the scheduled process.
FDA has the responsibility to establish United States identity, quality, and fill of container standards for a number of food commodities. Food standards, which essentially are definitions of food content and quality, are established under provisions of the FD&C Act. Standards have been established for a wide variety of products. These standards give consumers some guarantee of the kind and amount of major ingredients in these products. A food which purports to be a product for which a food standard has been promulgated must meet that standard or it may be deemed to be out of compliance and, therefore, subject to regulatory action.
Amendments to the FD&C Act establish nutrient requirements for infant formulas and provide FDA authority to establish good manufacturing practices and requirements for nutrient quantity, nutrient quality control, recordkeeping, and reporting. Under these Amendments, FDA factory inspection authority was expanded to manufacturer's records, quality control records, and test results necessary to determine compliance with the FD&C Act.
FDA has mandated Hazard Analysis Critical Control Point (HACCP) procedures for the seafood industry to assure safe processing, packaging, storage and distribution of both domestic and imported fish and fishery products. HACCP is a system by which food processors evaluate the kinds of hazards that could affect their products, institute controls necessary to keep hazards from occurring, monitor the performance of the controls, and maintain records of this monitoring as a matter of routine practice. The purpose of the proposed HACCP regulations is to establish mandatory preventative controls to ensure the safety of seafood products sold commercially in the United States and exported abroad. FDA will review the adequacy of HACCP controls in addition to its traditional inspection activities.
The food labeling regulations found in 21 CFR 101 and 105 contain the requirements which when followed result in honest and informative labeling of food. Mandatory labeling of food includes a statement of identity (common or usual name of the product - 21 CFR 101.3); a declaration of net quantity of contents (21 CFR 101.105); the name and place of business of the manufacturer, packer or distributor (21 CFR 101.5); and if fabricated from two or more ingredients, each ingredient must be listed in descending order of predominance by its common or usual name (21 CFR 101.4 and 101.6). Spices, flavoring and some coloring, other than those sold as such, may be designated as spices, flavoring and coloring without naming each. However, food containing a color additive that is subject to certification by FDA must be declared in the ingredients statement as containing that color.
On January 6, 1993 FDA issued final rules concerning food labeling as mandated by the Nutrition Labeling and Education Act (NLEA). These rules, which are included in the enclosed food labeling booklet, significantly revise many aspects of the existing food labeling regulations, mainly nutrition labeling and related claims for food. The NLEA regulations apply only to domestic food shipped in interstate commerce and to food products offered for import into the United States. The labeling of food products exported to a foreign country must comply with the requirements of that country.
If the label on a food product fails to make all the statements required by the FD&C Act, the FPLA and the regulations promulgated under these Acts, or if the label makes unwarranted claims for the product, the food is deemed to be misbranded. The FD&C Act provides for both civil and criminal action for misbranding. The FPLA provides for seizure and injunction. The legal responsibility for full compliance with the terms of each of these Acts and their regulations, as applied to labels, rests with the manufacturer, packer or distributor when the goods are entered into interstate commerce. The label of a food product may include the Universal Product Code (UPC) as well as a number of symbols which signify that: the trademark is registered with the U.S. Patent Office; the literary and artistic content of the label is protected against infringement under the copyright laws of the United States; and the food has been prepared and/or complies with dietary laws of certain religious groups. It is important to note that neither the UPC nor any of the symbols mentioned above are required by, or are under the authority of, any of the Acts enforced by the U.S. Food and Drug Administration.
The FD&C Act requires premarket approval for food additives (substances the intended use of which results or may reasonably be expected to result, directly or indirectly, either in their becoming a component of food or otherwise affecting the characteristics of food). The approval process involves a very careful review of the additive's safety for its intended use. Following the approval of a food additive, a regulation describing its use is published in the Code of Federal Regulations. As defined in the CFR, the term safe or safety, "...means there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance. Premarket clearance under the FD&C Act does assure that the risk of adverse effects occurring due to a food additive is at an acceptably small level.
FDA's regulation of dietary supplements is under the authority of the Dietary Supplements Health and Education Act of 1994. It ensures that the products are safe and properly labeled and that any disease or health-related claims are scient ifically supported. The legal provisions governing the safety of dietary supplements depend on whether the product is legally a food or a drug. In either instance the manufacturer is obligated to produce a safe product. Premarket safety review by FDA is required for new drugs.
The label of a dietary supplement is to state what the product contains, how much it contains, how it should be used, and precautions necessary to assure safe use with all other information being truthful and not misleading. If the dietary supplement is a food, a review of any disease of health-related claim is conducted under the NLEA health claim provisions.
Approval by FDA is not required to market a cosmetic in the United States. With the exception of color additives and a few prohibited or restricted ingredients, cosmetic manufacturers may, on their own responsibility, use essentially any raw material as a cosmetic ingredient and market the product without approval.
Therapeutic claims, either actual or implied, are not appropriate in the labeling of cosmetics. Products that are cosmetics but are also intended to treat or prevent disease, or affect the structure or functions of the body, are considered to be both drugs and cosmetics, and must comply with both the drug and cosmetic provisions of the law.
For more information about compliance with FDA's legal
requirements, and assistance with specific FDA's regulated
food and cosmetic products, you may contact:
Internet Web Site: http://www.fda.gov/
Hypertext updated by dms/ear 2001-AUG-15