FDA certification
The Food and Drug Administration (FDA) is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulatory agency, FDA's role is to ensure the safety of food, cosmetics, pharmaceuticals, biologics, medical devices, and radioactive products produced or imported in the United States. It was one of the first federal agencies to protect consumers as its primary function.
FDA profile and composition
The institution is closely related to the lives of every American citizen. Internationally, FDA is recognized as one of the world's largest food and drug regulatory agencies. Many other countries promote and monitor the safety of their domestic products by seeking and receiving FDA assistance.
Director of the Food and Drug Administration (FDA): food, pharmaceuticals (including veterinary drugs), medical devices, food additives, cosmetics, animal foods and pharmaceuticals, wine beverages with less than 7% alcohol content, and supervision of electronic products; also includes cosmetics Electronic products and medical products related to personal health and safety, such as radiation products and combination products. Ion, non-ionic radiation generated during the use or consumption of products affects the testing, testing and certification of human health and safety programs. According to the regulations, the above products must be FDA-approved to be safe before they can be sold in the market. The FDA has the right to inspect the manufacturer and have the right to sue the offender. According to the different product scope of supervision, it can be divided into the following major regulatory agencies:
1. Food Safety and Practical Nutrition Center (CFSAN):
The center is the most heavily funded department of the FDA. It is responsible for food safety throughout the United States, except for meat, poultry, and eggs under the jurisdiction of the US Department of Agriculture. Although the United States is the safest food supply country in the world, there are about 76 million foodborne diseases every year, and 32,000 people need hospitalization for food-borne diseases. About 5,000 people Died of foodborne illness. The Center for Food Safety and Nutrition is committed to reducing foodborne illness and promoting food safety. And promote various programs, such as the promotion and 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 bioprocesses; and managing activities in the proper identification of foods (eg ingredients, nutritional health claims) and cosmetics; Develop policies and regulations to manage dietary supplements, infant food formulas and medical foods; ensure the safety of cosmetic ingredients and products, ensure proper labeling; monitor and regulate after-sales behavior in the food industry; conduct consumer education and behavioral expansion; Cooperative projects between state and local governments; coordination of international food standards and safety.
2. Center for Drug Evaluation and Research (CDER):
The center aims to ensure the safety and effectiveness of prescription and over-the-counter drugs, evaluate new drugs before they are marketed, and monitor more than 10,000 drugs sold on the market to ensure that products meet the highest standards of constant renewal. At the same time, the center also regulates the authenticity of advertisements for drugs on television, radio and publications. Strictly supervise drugs to provide accurate and safe information to consumers.
3. Equipment Safety and Radiation Protection Health Center (CDRH):
The center is ensuring the safety and effectiveness of newly listed 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 prosthetic heart valves. These products are closely related to the lives of the same people, so the center also regulates after-sales services nationwide. For some products that generate radiation, such as microwave ovens, televisions, mobile phones, etc., the center has also identified some corresponding safety standards.
4. Center for Biological Products Evaluation and Research (CBER):
The Center regulates biological products that prevent and treat diseases and is therefore more complex than chemically integrated drugs, including scientific research on the safety and efficacy of blood, plasma, vaccines, etc.
5. Veterinary Drug Center (CVM):
FDA certification introduction
Food FDA certification
The FDA's agency for food, agricultural products, and seafood is the Center for Food Safety and Nutrition (CFASAN), which is responsible for ensuring that American food supplies are safe, clean, fresh, and clearly labeled.
The food supervised by the Center imports 240 billion US dollars annually, of which 15 billion are imported food. The main monitoring highlights of the center include:
1. Food freshness; 2. Food additives; 3. Other harmful components of food biotoxins; 4. Safety analysis of seafood; 5. Food identification; 6. Tracking and warning after food listing
According to the anti-terrorism law passed by the US Congress in 2003, food companies outside the United States must register with the FDA before exporting to the United States, and notify the FDA of shipments at the time of export.
Foreign food production and processing enterprises that must be registered with the FDA in accordance with the US Public Order 107-188:
1. Wine and alcoholic beverages;
2. Baby and children's food;
3, bread and pastry;
4, beverages;
5. Confectionery (including chewing gum);
6. Oatmeal and ready-to-eat cereals;
7. Cheese and cheese products;
8. Chocolate and cocoa foods;
9. Coffee and tea products;
10. Pigment for food;
11, weight loss regular food and medicinal food, meat substitutes;
12. Supplementary foods (ie domestic healthy foods, vitamins and Chinese herbal medicines);
13 seasonings;
14. Fish and seafood;
15 materials and products placed in food and in direct contact with food;
16. Agents and safe ingredients for food;
17. Food substitute sugar;
18. Fruit and fruit products;
19. Edible gum, milk enzyme, pudding and stuffing;
20, ice cream and related foods;
21. Imitation dairy products;
22, macaroni and noodles;
23. Meat, meat products and poultry products;
24. Milk, butter and dry dairy products;
25, dinner food and marinade, sauces and specialty products;
26. Dried fruit and nuts;
27. Shelled eggs and egg products;
28, snacks (flour, meat and vegetables);
29, pepper, special flavors and salt;
30, soup;
31. Soft drinks and canned water;
32. Vegetable and vegetable products;
33. Vegetable oil (including olive oil);
34, vegetable protein products (square meat food);
35. Whole wheat food and flour processed food, starch, etc.;
36. Main or all products for human consumption;