The Food and Drug Administration, or FDA for short, is one of the executive agencies established by the U.S. government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS).
As a scientific management agency, the FDA's role is to ensure the safety of food, cosmetics, drugs, biologics, medical devices, and radiological products produced or imported in the United States. It was one of the earliest federal agencies to protect consumers. The agency is closely related to the life of every American citizen. Internationally, the FDA is recognized as one of the world's largest food and drug regulatory agencies. Many other countries seek and receive help from the FDA to promote and monitor the safety of their products.
Food and Drug Administration (FDA) Supervisor: Food, Drugs (including Veterinary Drugs), Medical Devices, Food Additives, Cosmetics, Animal Food and Drugs, Wine and Beverages with Electronic Contents Less Than 7%, and Supervision and Inspection of Electronic Products; Products in Use Testing, inspection and certification of ionic and non-ionic radiation generated during consumption or consumption affecting human health and safety projects. According to regulations, the above products can only be sold on the market after they have been proven safe by FDA inspection. FDA has the right to inspect manufacturers and prosecute offenders. According to the different product scopes regulated, it can be divided into the following major regulators:
1. Center for Food Safety and Practical Nutrition (CFSAN):
The center is the department with the most workload for FDA. It is responsible for food safety throughout the United States, except for meat, poultry, and eggs under the jurisdiction of the United States Department of Agriculture. Although the United States is the safest country in food supply in the world, about 76 million foodborne illnesses occur every year, 325,000 people need hospitalization due to foodborne illness, and about 5,000 people Died from foodborne illness. The Center for Food Safety and Nutrition is committed to reducing foodborne illness and promoting food safety. And promote various plans, such as: the implementation of the HACCP plan.
The functions of the center include: ensuring the safety of substances and pigments added to food; ensuring the safety of foods and ingredients developed through biotechnology; responsible for management activities in the proper identification of foods (such as ingredients, nutrition and health statements) and cosmetics; Formulate corresponding policies and regulations to manage dietary supplements, infant food formulas and medical foods; ensure the safety of cosmetic ingredients and products, ensure correct labeling; monitor and regulate after-sale behavior in the food industry; conduct consumer education and behavior development; and Cooperative projects between state and local governments; coordination of international food standards and safety, etc.
2, Center for Drug Evaluation and Research (CDER):
中心 The center aims to ensure the safety and effectiveness of prescription and over-the-counter medicines, evaluate new medicines before they are launched, and monitor more than 10,000 medicines sold on the market to ensure that products meet the highest standards for continuous updates. It also oversees the authenticity of advertisements for medicines on television, radio and publications. Strictly monitor drugs and provide consumers with accurate and safe information.
3. Equipment Safety and Radiation Protection Health Center (CDRH):
The center is ensuring the safety and effectiveness of newly marketed medical devices. Because more than 20,000 companies around the world produce more than 80,000 types of medical devices from blood glucose monitors to artificial heart valves. These products are closely related to human life, so the center also supervises after-sales service nationwide. For some products that can produce radiation such as microwave ovens, televisions, mobile phones, etc., the center has also determined some corresponding safety standards.
4. Center for Biological Products Evaluation and Research (CBER):
中心 The center supervises biological products that can prevent and treat diseases, so it is more complex than chemical comprehensive drugs. It includes scientific research on the safety and effectiveness of blood, plasma, vaccines, etc.
5.Veterinary Drug Center (CVM):
The center monitors animal foods and medicines to ensure that these products are practical, safe and effective in maintaining life and reducing pain.
1. FDA certification for food contact materials
Food contact materials refer to all materials that can be contacted with food during the process of packaging, storage, transportation, and transportation of food. Common materials include various plastic metal ceramic glass bamboo and wood products. These materials that are in contact with food are environmentally safe The situation is directly related to the safety and health of the user's diet, so exporting such products to the United States requires relevant testing and certification in accordance with FDA standards.
2. FDA certification testing items for common food contact materials are as follows:
Organic coating, metal and electroplated products require U.S. FDA CFR 21 175.300.
Water extractives
8% alcohol extractives
N-heptane extractives
Paper products require U.S. FDA CFR 21 176.170
Net chloroform soluble extractives for water fraction (deionized water extraction method).
Net chloroform soluble extractives for 8% alcohol fraction
Net chloroform soluble extractives for 50% alcohol fraction
Net chloroform soluble extractives for n-heptane fraction (n-heptane extraction method)
Wood requirements U.S. FDA CFR 21 178.3800
Pentachlorophenol and its salt PCP
ABS requires U.S. FDA CFR 21 181.32 or 180.22.
In water
In 3% acetic acid
In 8% ethanol
In n-heptane
As a scientific management agency, the FDA's role is to ensure the safety of food, cosmetics, drugs, biologics, medical devices, and radiological products produced or imported in the United States. It was one of the earliest federal agencies to protect consumers. The agency is closely related to the life of every American citizen. Internationally, the FDA is recognized as one of the world's largest food and drug regulatory agencies. Many other countries seek and receive help from the FDA to promote and monitor the safety of their products.
Food and Drug Administration (FDA) Supervisor: Food, Drugs (including Veterinary Drugs), Medical Devices, Food Additives, Cosmetics, Animal Food and Drugs, Wine and Beverages with Electronic Contents Less Than 7%, and Supervision and Inspection of Electronic Products; Products in Use Testing, inspection and certification of ionic and non-ionic radiation generated during consumption or consumption affecting human health and safety projects. According to regulations, the above products can only be sold on the market after they have been proven safe by FDA inspection. FDA has the right to inspect manufacturers and prosecute offenders. According to the different product scopes regulated, it can be divided into the following major regulators:
1. Center for Food Safety and Practical Nutrition (CFSAN):
The center is the department with the most workload for FDA. It is responsible for food safety throughout the United States, except for meat, poultry, and eggs under the jurisdiction of the United States Department of Agriculture. Although the United States is the safest country in food supply in the world, about 76 million foodborne illnesses occur every year, 325,000 people need hospitalization due to foodborne illness, and about 5,000 people Died from foodborne illness. The Center for Food Safety and Nutrition is committed to reducing foodborne illness and promoting food safety. And promote various plans, such as: the implementation of the HACCP plan.
The functions of the center include: ensuring the safety of substances and pigments added to food; ensuring the safety of foods and ingredients developed through biotechnology; responsible for management activities in the proper identification of foods (such as ingredients, nutrition and health statements) and cosmetics; Formulate corresponding policies and regulations to manage dietary supplements, infant food formulas and medical foods; ensure the safety of cosmetic ingredients and products, ensure correct labeling; monitor and regulate after-sale behavior in the food industry; conduct consumer education and behavior development; and Cooperative projects between state and local governments; coordination of international food standards and safety, etc.
2, Center for Drug Evaluation and Research (CDER):
中心 The center aims to ensure the safety and effectiveness of prescription and over-the-counter medicines, evaluate new medicines before they are launched, and monitor more than 10,000 medicines sold on the market to ensure that products meet the highest standards for continuous updates. It also oversees the authenticity of advertisements for medicines on television, radio and publications. Strictly monitor drugs and provide consumers with accurate and safe information.
3. Equipment Safety and Radiation Protection Health Center (CDRH):
The center is ensuring the safety and effectiveness of newly marketed medical devices. Because more than 20,000 companies around the world produce more than 80,000 types of medical devices from blood glucose monitors to artificial heart valves. These products are closely related to human life, so the center also supervises after-sales service nationwide. For some products that can produce radiation such as microwave ovens, televisions, mobile phones, etc., the center has also determined some corresponding safety standards.
4. Center for Biological Products Evaluation and Research (CBER):
中心 The center supervises biological products that can prevent and treat diseases, so it is more complex than chemical comprehensive drugs. It includes scientific research on the safety and effectiveness of blood, plasma, vaccines, etc.
5.Veterinary Drug Center (CVM):
The center monitors animal foods and medicines to ensure that these products are practical, safe and effective in maintaining life and reducing pain.
1. FDA certification for food contact materials
Food contact materials refer to all materials that can be contacted with food during the process of packaging, storage, transportation, and transportation of food. Common materials include various plastic metal ceramic glass bamboo and wood products. These materials that are in contact with food are environmentally safe The situation is directly related to the safety and health of the user's diet, so exporting such products to the United States requires relevant testing and certification in accordance with FDA standards.
2. FDA certification testing items for common food contact materials are as follows:
Organic coating, metal and electroplated products require U.S. FDA CFR 21 175.300.
Water extractives
8% alcohol extractives
N-heptane extractives
Paper products require U.S. FDA CFR 21 176.170
Net chloroform soluble extractives for water fraction (deionized water extraction method).
Net chloroform soluble extractives for 8% alcohol fraction
Net chloroform soluble extractives for 50% alcohol fraction
Net chloroform soluble extractives for n-heptane fraction (n-heptane extraction method)
Wood requirements U.S. FDA CFR 21 178.3800
Pentachlorophenol and its salt PCP
ABS requires U.S. FDA CFR 21 181.32 or 180.22.
In water
In 3% acetic acid
In 8% ethanol
In n-heptane