The Center for Food Safety and Applied Nutrition is also responsible for establishing and modifying food standards, such as identity standards (such as what conditions a product needs to be labeled as "yogurt"), and formulating nutrition labeling requirements for most foods. The standards of these two parts are contained in federal regulations. 1994 passed the dietary supplement health and education law, which designated the US Food and Drug Administration to be responsible for the supervision of dietary supplements. However, the law does not require testing the safety and effectiveness of dietary supplements, and so far there is no statutory standard, so the US Food and Drug Administration can only take action when it proves that dietary supplements are unsafe. Manufacturers of dietary supplements are allowed to make "structural or functional statements" about the right to health in the labels of these products. They may not claim that the product can treat, diagnose, cure or prevent diseases, but the label must contain some kind of disclaimer.
Bottled water in the US market is jointly supervised by the US Food and Drug Administration and the state government, while tap water is governed by state laws and local regulations and supervised by the Federal Environmental Protection Agency. The supervision of bottled water by the US Food and Drug Administration must follow the guidelines formulated by the Federal Environmental Protection Agency, and the new EPA regulations will automatically apply to the supervision of bottled water unless the US Food and Drug Administration makes more detailed regulations. Although the quality control of bottled water industry in the United States is not as strict as that of urban water supply, bottled water in the American market still needs to be inspected like other foods. The Center for Drug Evaluation and Research has set different standards for new drugs, generic drugs and over-the-counter drugs. A drug is called a "new drug" if it is produced by different manufacturers with different excipients or no active ingredients for different therapeutic purposes, or if it has undergone any other substantial changes. The most stringent requirement for new drugs is that they cannot be the same as any existing drugs at the level of "new molecular entities".
Newly developed drugs
A lot of research and observation are needed before the US Food and Drug Administration approves a new drug. This process is called "NDA". By default, new drugs can only be purchased by doctor's advice. When a new drug becomes an over-the-counter drug (OTC), it needs to go through the new drug application review process and get approval, and then there must be an independent review process.
The approval of a new drug means that it is "safe and effective for direct use".
Advertising and promotion
The US Food and Drug Administration is responsible for reviewing and managing the advertising and promotion activities of prescription drugs. (Other types of advertisements, including over-the-counter advertisements, are regulated by the Federal Trade Commission. ) There are two key requirements for drug advertising supervision. First of all, in most cases, drug manufacturers can only publicize the specific characteristics or medical uses of approved drugs. Off-indication use, that is, the use of drugs other than the approved use, is very common in medical practice. At the same time, advertising should pay attention to the balance between promoting the advantages of drugs and reminding users of the possible risks of drugs.
Safety observation of drugs after marketing
After passing the new drug application review procedure and obtaining approval, the drug manufacturer must review and report to the US Food and Drug Administration every adverse drug reaction event it knows. Very serious and fatal adverse drug reactions must be reported within 15 days; Other events are reported quarterly. The US Food and Drug Administration can also obtain ADR reports directly through its safety information and ADR notification program (MedWatch program). Because these reports are reported by users or medical professionals, they are called "spontaneous reports". Although this has become the most important means of post-marketing safety observation, the necessity of post-marketing risk management by the US Food and Drug Administration is still increasing. When the drug is approved, the manufacturer needs to conduct more additional clinical trials, which is called the fourth stage of clinical trials of new drugs. In some cases, the drug risk management required by the US Food and Drug Administration may include other kinds of research, restrictions or safety observation measures.
generic drugs
Generic drugs are prescription drugs whose patent protection has expired, so other manufacturers are allowed to produce and sell them. For the approval of generic drugs, the US Food and Drug Administration needs scientific evidence to prove that the drug can replace or be equivalent to the originally approved drug in therapeutic sense.
Over-the-counter drugs/medicines
Over-the-counter drugs are drugs and compounds that can be obtained without a doctor's prescription. The US Food and Drug Administration has listed a list, in which nearly 800 ingredients are combined in various ways to produce more than 654.38+10,000 kinds of over-the-counter drugs. In addition, many over-the-counter ingredients also belong to the category of prescription drugs, but they are considered to be safe to use without the supervision of medical personnel. Vaccine, blood, human tissue products and biological products are supervised by the Biological Products Evaluation and Research Center, a branch of the US Food and Drug Administration, which is responsible for the safety and effectiveness of biotherapy. The regulated products include blood and blood products, vaccines, allergens, human tissue products and gene therapy products. New biomedical products need to go through the application review process similar to drugs before they go on the market. The original authorization for the government to supervise biomedical products comes from the Biological Products Control Law of 1902 and the additional authorization comes from the Public Health Service Law of 1944. In addition, the Federal Food, Drug and Cosmetic Act also applies to the regulation of biomedical products. The original organization responsible for the supervision of biomedical products belongs to the National Institutes of Health, and this authorization was transferred to the US Food and Drug Administration on 1972. The Center for Equipment, Instruments and Radiological Hygiene is a branch of the US Food and Drug Administration. It is responsible for the pre-marketing approval of all medical devices and supervises their manufacture, working performance and safety. In the Federal Food, Drug and Cosmetic Act, "medical equipment" is defined, which includes many instruments, from simple toothbrushes to complex implantable brain pacemakers. The Center for Equipment, Instruments and Radiation Health is also responsible for supervising the safety performance of radioactive non-medical equipment, including mobile phones, airport baggage inspection equipment, TV receivers, microwave ovens, ultraviolet health rooms and laser products.
The management responsibilities of equipment, instruments and radiological health centers include requiring equipment manufacturers or importers to submit technical reports of equipment, requiring radioactive equipment to meet safety performance indicators, publishing defective products, and requiring the recall of defective or invalid products. The Center for Equipment, Instruments and Radiological Hygiene also directly tests some products. The Veterinary Center is a branch of the US Food and Drug Administration, which is responsible for supervising the food, food additives and drugs provided to animals including food animals and pets. Veterinary centers are not responsible for supervising animal vaccines, and such products are managed by the United States Department of Agriculture.
The most basic work of the Veterinary Medicine Center is to supervise the drugs provided to food animals and ensure that they will not affect the food supply to human beings. The work of the US Food and Drug Administration to control mad cow disease is also implemented through the inspection of feed manufacturers by veterinary centers. On June 5438+February 65438+February 9, 2007, the US Food and Drug Administration announced the establishment of a database to track cloned animals in the food system in order to effectively carry out relevant identification procedures. This database will be part of the national animal identification system, which will be used to track all domestic animals in the United States from farm to table.