The Center for Food Safety and Applied Nutrition is the branch of the Food and Drug Administration responsible for regulating the safety and labeling of virtually all food products in the United States. Those not under its regulatory purview include meat products from domesticated animals, such as beef and chicken, which are regulated by the U.S. Department of Agriculture's Food Safety and Inspection Service. Products containing trace amounts of meat, on the other hand, are regulated by the U.S. Food and Drug Administration. The precise boundaries between the two are outlined in a memorandum of understanding between the two departments. In addition, drugs and other products for livestock are regulated by the Center for Veterinary Medicine, another branch of the FDA. Other consumer products not regulated by the FDA include beverages with more than 7 percent alcohol (regulated by the U.S. federal Department of Justice's Bureau of Alcohol, Tobacco, Firearms and Explosives) and non-bottled drinking water (regulated by the U.S. National Environmental Protection Agency).
The Center for Food Safety and Applied Nutrition is also responsible for establishing and revising food standards, such as standards of identity (e.g., what it takes for a product to be labeled "yogurt"), and setting nutritional labeling requirements for most foods. Both of these standards are included in the Code of Federal Regulations, and the Dietary Supplement Health and Education Act, passed in 1994, assigns responsibility for the regulation of dietary supplements to the U.S. Food and Drug Administration. regulation of dietary supplements. However, the law does not require safety and efficacy testing of dietary supplements, and to date, there are no statutory standards, so the FDA can only take action when a dietary supplement is shown to be unsafe. Manufacturers of dietary supplements are allowed to make "structure or function claims" about health benefits in the labeling of these products. They may not claim that the product treats, diagnoses, cures, or prevents a disease, but some sort of disclaimer must be included in the labeling.
Bottled water in the U.S. market is regulated by the FDA in conjunction with state governments, while tap water is subject to state and local regulations and is regulated by the federal Environmental Protection Agency. The FDA's regulation of bottled water is subject to guidelines established by the federal EPA, and the newly established EPA regulations automatically apply to the regulation of bottled water, unless the FDA redefines them in more detail. Although quality control in the U.S. bottled water industry is not as stringent as for municipal water supplies, bottled water bottles in the U.S. market are still required to undergo inspections similar to those for other foods. The Center for Drug Evaluation and Research (CDERA) sets different standards for three broad categories of drugs: new drugs, generic drugs, and over-the-counter drugs. A drug is new if it is made by a different manufacturer using different excipients or inactive ingredients, if it is used for a different therapeutic purpose, or if there has been any other substantial change in the drug. The most stringent requirement for a new drug is that it must not be identical to any existing drug at the level of "new molecular entities" (new molecular entities).
New Drugs
New drugs are subject to a large number of studies before they are approved by the FDA, a process known as the New Drug Application Review process (NDA). By default, new drugs are available only by medical prescription. For a new drug to become over-the-counter (OTC) it first needs to go through the New Drug Application Review process and be approved, followed by an independent review process.
An approved drug means that it is "safe and effective when used directly".
Advertising and Promotion
The U.S. Food and Drug Administration is responsible for reviewing and regulating advertising and promotion of prescription drugs. (Other types of advertising, including over-the-counter advertising, are regulated by the Federal Trade Commission.) There are two key requirements in the regulation of drug advertising. One is that, in most cases, a drug manufacturer may only advertise a specific approved characteristic or medical use of a drug. Off-label use, the use of a drug for purposes other than those for which it is approved, is common in medical practice. Advertisements also need to strike a balance between promoting the benefits of the drug and warning users of the potential risks of the drug.
Post-market safety observations
After going through the New Drug Application review process and being approved, a drug manufacturer must review and report to the FDA every adverse drug reaction event it has. Very serious and fatal adverse drug events must be reported within 15 days; other events are reported quarterly. The FDA can also obtain ADR reports directly through its MedWatch program, which are called "spontaneous reports" because they are initiated by users or healthcare professionals. Although this has become the primary means of post-marketing safety observation, the need for post-marketing risk management by the U.S. Food and Drug Administration continues to grow. When a drug is approved, the manufacturer is required to conduct additional clinical trials, known as Phase IV clinical trials. In some cases, drug risk management required by the FDA may include other kinds of studies, restraints, or safety observations.
Generic Drugs
Generic drugs are prescription drugs whose patent protection has expired, thus allowing other manufacturers to make and sell them. For a generic drug to be approved, the U.S. Food and Drug Administration requires scientific evidence that the drug is interchangeable or equivalent in a therapeutic sense to the drug for which it was originally approved.
Over-the-counter drugs
Over-the-counter drugs are medicines and compounds that can be obtained without a doctor's prescription. The U.S. Food and Drug Administration lists a list of nearly 800 ingredients that have been combined in a variety of ways to produce more than 100,000 over-the-counter drugs. In addition, many of the components of OTC drugs are also prescription drugs, but are considered safe for use without medical supervision. Regulation of Vaccines, Blood and Human Cell Tissue Products, and Biological Agents The Center for Biologics Review and Research (CBR), the FDA's division responsible for the safety and effectiveness of biological therapies, regulates products such as blood and blood preparations, vaccines, allergens, human cell tissue products, and gene therapy products. New biologic medical products undergo an application review process similar to that for drugs before they can be marketed. The original authorization for government regulation of biological medical products comes from the Biologics Control Act of 1902, with additional authorization from the Public Health Service Act of 1944. In addition, the Federal Food, Drug, and Cosmetic Act (FFDCA) applies to the regulation of biological medical products. The original agency with regulatory responsibility for biological medical products was the National Institutes of Health, but in 1972 this authority was transferred to the U.S. Food and Drug Administration. The Center for Devices, Instruments, and Radiological Health (CDIRH) is the branch of the U.S. Food and Drug Administration (FDA) that is responsible for pre-market approval of all medical devices and for regulating the manufacture, performance, and safety of these devices. A "medical device" is defined in the Federal Food, Drug, and Cosmetic Act and includes a wide range of devices from simple ones such as toothbrushes to complex ones such as implantable brain pacemakers. The Center for Devices, Instruments, and Radiological Health also regulates the safety of non-medical devices that emit radiation, including cell phones, airport baggage screening equipment, television receivers, microwave ovens, ultraviolet health rooms, and laser products.
The Center for Devices, Instruments and Radiological Health's regulatory authority and responsibility includes requiring device manufacturers or importers to submit technical reports on devices, requiring radiological devices to meet safety performance specifications, publicizing defective products, and requiring recalls of defective or ineffective products. The Center for Devices, Instruments, and Radiological Health also directly conducts some product testing. The Center for Veterinary Medicine (CVM) is the branch of the U.S. Food and Drug Administration responsible for regulating food, food additives, and drugs provided to animals, including food animals and pets. The Center for Veterinary Medicine does not regulate animal vaccines, which are regulated by the U.S. Department of Agriculture.
The most basic job of the Center for Veterinary Medicine is to regulate drugs provided to food animals to ensure that they do not interfere with the food supply to humans. The U.S. Food and Drug Administration's efforts to control mad cow disease are also carried out through inspections of feed manufacturers by the Center for Veterinary Medicine. On December 19, 2007, the U.S. Food and Drug Administration announced the creation of a database to track cloned animals in the food system to enable effective identification procedures. The database will be part of the National Animal Identification System, which tracks all livestock from farm to table across the United States.