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US FDA certification
- Time：2018-04-19
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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.
Introduction
The institution is closely related to the lives of every American citizen. Internationally, the 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 products in the country 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):
Certification introduction
Food 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. Freshness of food;
2. Food additives;
3. Other harmful components of food biotoxins;
4. Seafood safety analysis;
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, drinks;
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. Food additives and safe ingredients;
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;
Medical certification
The FDA's management of medical devices is carried out through the Center for Devices and Radiological Health (CDRH), which supervises the production, packaging, and distribution of medical devices to comply with the law.
The range of medical devices ranges from medical gloves to cardiac pacemakers, all under the supervision of the FDA. According to medical uses and possible harm to the human body, the FDA classifies medical devices into categories I, II, and III. The more categories are supervised.
If the product is a novel invention that does not exist on the market, the FDA requires manufacturers to conduct rigorous human experiments with convincing medical and statistical evidence to demonstrate the effectiveness and safety of the product.
FDA certification for medical devices, including: FDA registration, FDA registration of products, product listing registration (510 form registration), product listing approval (PMA review) labeling and technical transformation of health care equipment, customs clearance, registration, pre-IPO The report shall submit the following materials: (1) five copies of the finished product, (2) the structural drawing of the device and its textual description, (3) the performance and working principle of the device; and (4) the safety demonstration or test material of the device. (5) Introduction to the manufacturing process, (6) Summary of clinical trials, (7) Product specification. If the device has radioactive energy or releases radioactive material, it must be described in detail.
Registration and certification process
The FDA has a clear and rigorous definition of medical devices, which are defined as follows: “A medical device is an instrument, device, tool, machine, appliance, insertion tube, in vitro reagent, and other related items that meet the following conditions, including components, parts, or Attachment: Apparently listed in the National Formulary or the Unite States Pharmacopeia or in the appendices of both; intended for use in animal or human diseases, or in the diagnosis of other physical conditions, or in the treatment, mitigation and treatment of the disease; Animals or human body functions or structures, but not through metabolism to achieve their primary purpose."
Only products that meet the above definitions are regarded as medical devices. Under this definition, not only the various instruments and tools in the hospital, but also the eyeglass frames, spectacle lenses, toothbrushes and massagers that consumers can purchase in general stores. These are all within the scope of the FDA. It is slightly different from the domestic identification of medical devices.
Depending on the level of risk, the FDA classifies medical devices into three categories (I, II, III) with the highest level of risk. The FDA has clearly defined its product classification and management requirements for each medical device, and the FDA Medical Device Catalogue has more than 1,700 products. Any medical device that wants to enter the US market must first identify the classification and management requirements for the application for listing.
The FDA has a number of bills for medical devices that are revised and supplemented from time to time, but there are not many fundamental bills, including: the Federal Food, Drug, and Cosmetic Act (FD&C Act, the Fundamental Act); the Public Health Services Act; And the Identification Act; the Health and Safety Radiation Control Act; the Safe Medical Device Act; the Modernization Act. The FDA gives a very detailed explanation of these bills and is accompanied by specific operational requirements. Before planning to enter the US market, companies need to carefully evaluate the regulations and specific requirements (including different US product standards) for their products.
After the above information is clarified, the company can proceed to prepare the relevant application materials and report to the FDA for approval and approval according to certain procedures. For any product, companies need to register for the company and list the products. For Class I products (about 47%), General Control is implemented. Most products only need to be registered, listed, and implemented GMP specifications, and products can enter the US market (of which very few products are even GMP). Exemption, a very small number of reserved products are required to submit 510 (K) application to the FDA (PMN (Premarket Notification)); for Class II products (about 46%), special control (Special Control) is implemented, the company is registering and After listing, GMP and 510(K) applications are required (very few products are 510(K) exemptions); for Class III products (about 7%), pre-market licensing is implemented, companies are registering and After listing, GMP must be implemented and a PMA (Premarket Application) application (some Class III products or PMN) should be submitted to the FDA.
For Class I products, after the company submits relevant information to the FDA, the FDA only announces that no relevant documents are issued to the enterprise; for Class II and III devices, the enterprise must submit PMN or PMA, and the FDA will give the enterprise A formal market access approval letter (Clearance) allows companies to sell their products directly in the US medical device market under their own name. As for whether the company has conducted on-site GMP assessment during the application process, the FDA will determine the comprehensive factors such as product risk level, management requirements and market feedback.
Based on the above, most products can be approved by the FDA after they have been registered, listed, and implemented GMP, or submitted to 510(K).
The 1.510(K) document, also known as the FDA's documentation for PMN, is commonly referred to as the 510(K) document for its corresponding 510th chapter of the FD&C Act.
2. Substantial equality comparison (SE)
3.510(K) review process
Before applying, it must be clear whether the product is recognized by the FDA as a medical device, product category, management requirements, and clearly apply for the work content;
Whether there is any US mandatory standard for the products that are applied for listing, and whether the products meet the standards (generally require the formal inspection report of the testing organization);
Before preparing the 510(K) application documents, consider whether you really need to submit, when to submit, and which type of 510(K) application to submit: General 510 (K), Special 510 (K), Simplified 510 (K) ;
Written and timely answers to questions raised by the FDA during the application process;
All papers submitted to the FDA should be Letter Size (21.5cm X 29.7cm);
All FDA-delivered data companies need to have a backup, because the FDA will electronically scan the application after receiving the application materials, and destroy the application materials, and will not return the enterprise.
For a small number of products, the FDA will conduct on-site GMP assessments for enterprises. Enterprises must refer to US GMP management requirements and provide appropriate translators with a certain understanding of GMP and enterprises during FDA on-site audits;
Inform the FDA's official contacts to have a certain understanding of FDA regulations and work procedures, and to communicate directly with the FDA to facilitate timely feedback, companies can identify themselves or entrust the consulting agency responsible for daily communication with the FDA.
Cosmetic certification
Cosmetic Voluntary Registration Scheme (VCRP)
The FDA Office of Cosmetics and Colors has developed a voluntary voluntary registration program for cosmetics in response to the requirements of the cosmetics industry. The plan consists of two parts: voluntary registration of cosmetic manufacturers and declaration of cosmetic ingredients.
Benefits of participating in VCRP
Voluntary registration by the manufacturer and obtaining the registration number does not mean that the FDA approves the manufacturer or its products. The FDA does not allow the manufacturer to use the registration number or listing number to participate in the VCRP for commercial promotion; however, the manufacturer can directly obtain the following by participating in the VCRP. interest:
Get important information about cosmetic ingredients. The FDA enters all information obtained from the VCRP into a computer database. If a cosmetic ingredient currently in use is considered to be harmful and should be banned, FDA will notify the manufacturer or distributor of the product through the address book in the VCRP database. If your product is not in the registration database, FDA will not be able to notify you.
Avoid being detained when the product is recalled or imported due to ingredient problems. If the cosmetic manufacturer formulates the product in VCRP, as long as the FDA finds that the manufacturer uses unapproved color additives or other prohibited ingredients in the formulation, it will remind the manufacturer. In this way, the manufacturer can modify the product formulation before the product is imported or sold, thereby eliminating the risk of the product being recalled or detained due to the use of the improper component. Help retailers identify safety-conscious manufacturers. Retailers (such as department stores) sometimes ask if an FDA cosmetic company is registered with the FDA. Although registration does not imply FDA approval, it indicates that your product has been reviewed by the FDA and entered the government database. If the product formula you submitted is incomplete, or contains some kind of
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.
Introduction
The institution is closely related to the lives of every American citizen. Internationally, the 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 products in the country 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):
Certification introduction
Food 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. Freshness of food;
2. Food additives;
3. Other harmful components of food biotoxins;
4. Seafood safety analysis;
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, drinks;
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. Food additives and safe ingredients;
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;
Medical certification
The FDA's management of medical devices is carried out through the Center for Devices and Radiological Health (CDRH), which supervises the production, packaging, and distribution of medical devices to comply with the law.
The range of medical devices ranges from medical gloves to cardiac pacemakers, all under the supervision of the FDA. According to medical uses and possible harm to the human body, the FDA classifies medical devices into categories I, II, and III. The more categories are supervised.
If the product is a novel invention that does not exist on the market, the FDA requires manufacturers to conduct rigorous human experiments with convincing medical and statistical evidence to demonstrate the effectiveness and safety of the product.
FDA certification for medical devices, including: FDA registration, FDA registration of products, product listing registration (510 form registration), product listing approval (PMA review) labeling and technical transformation of health care equipment, customs clearance, registration, pre-IPO The report shall submit the following materials: (1) five copies of the finished product, (2) the structural drawing of the device and its textual description, (3) the performance and working principle of the device; and (4) the safety demonstration or test material of the device. (5) Introduction to the manufacturing process, (6) Summary of clinical trials, (7) Product specification. If the device has radioactive energy or releases radioactive material, it must be described in detail.
Registration and certification process
The FDA has a clear and rigorous definition of medical devices, which are defined as follows: “A medical device is an instrument, device, tool, machine, appliance, insertion tube, in vitro reagent, and other related items that meet the following conditions, including components, parts, or Attachment: Apparently listed in the National Formulary or the Unite States Pharmacopeia or in the appendices of both; intended for use in animal or human diseases, or in the diagnosis of other physical conditions, or in the treatment, mitigation and treatment of the disease; Animals or human body functions or structures, but not through metabolism to achieve their primary purpose."
Only products that meet the above definitions are regarded as medical devices. Under this definition, not only the various instruments and tools in the hospital, but also the eyeglass frames, spectacle lenses, toothbrushes and massagers that consumers can purchase in general stores. These are all within the scope of the FDA. It is slightly different from the domestic identification of medical devices.
Depending on the level of risk, the FDA classifies medical devices into three categories (I, II, III) with the highest level of risk. The FDA has clearly defined its product classification and management requirements for each medical device, and the FDA Medical Device Catalogue has more than 1,700 products. Any medical device that wants to enter the US market must first identify the classification and management requirements for the application for listing.
The FDA has a number of bills for medical devices that are revised and supplemented from time to time, but there are not many fundamental bills, including: the Federal Food, Drug, and Cosmetic Act (FD&C Act, the Fundamental Act); the Public Health Services Act; And the Identification Act; the Health and Safety Radiation Control Act; the Safe Medical Device Act; the Modernization Act. The FDA gives a very detailed explanation of these bills and is accompanied by specific operational requirements. Before planning to enter the US market, companies need to carefully evaluate the regulations and specific requirements (including different US product standards) for their products.
After the above information is clarified, the company can proceed to prepare the relevant application materials and report to the FDA for approval and approval according to certain procedures. For any product, companies need to register for the company and list the products. For Class I products (about 47%), General Control is implemented. Most products only need to be registered, listed, and implemented GMP specifications, and products can enter the US market (of which very few products are even GMP). Exemption, a very small number of reserved products are required to submit 510 (K) application to the FDA (PMN (Premarket Notification)); for Class II products (about 46%), special control (Special Control) is implemented, the company is registering and After listing, GMP and 510(K) applications are required (very few products are 510(K) exemptions); for Class III products (about 7%), pre-market licensing is implemented, companies are registering and After listing, GMP must be implemented and a PMA (Premarket Application) application (some Class III products or PMN) should be submitted to the FDA.
For Class I products, after the company submits relevant information to the FDA, the FDA only announces that no relevant documents are issued to the enterprise; for Class II and III devices, the enterprise must submit PMN or PMA, and the FDA will give the enterprise A formal market access approval letter (Clearance) allows companies to sell their products directly in the US medical device market under their own name. As for whether the company has conducted on-site GMP assessment during the application process, the FDA will determine the comprehensive factors such as product risk level, management requirements and market feedback.
Based on the above, most products can be approved by the FDA after they have been registered, listed, and implemented GMP, or submitted to 510(K).
The 1.510(K) document, also known as the FDA's documentation for PMN, is commonly referred to as the 510(K) document for its corresponding 510th chapter of the FD&C Act.
2. Substantial equality comparison (SE)
3.510(K) review process
Before applying, it must be clear whether the product is recognized by the FDA as a medical device, product category, management requirements, and clearly apply for the work content;
Whether there is any US mandatory standard for the products that are applied for listing, and whether the products meet the standards (generally require the formal inspection report of the testing organization);
Before preparing the 510(K) application documents, consider whether you really need to submit, when to submit, and which type of 510(K) application to submit: General 510 (K), Special 510 (K), Simplified 510 (K) ;
Written and timely answers to questions raised by the FDA during the application process;
All papers submitted to the FDA should be Letter Size (21.5cm X 29.7cm);
All FDA-delivered data companies need to have a backup, because the FDA will electronically scan the application after receiving the application materials, and destroy the application materials, and will not return the enterprise.
For a small number of products, the FDA will conduct on-site GMP assessments for enterprises. Enterprises must refer to US GMP management requirements and provide appropriate translators with a certain understanding of GMP and enterprises during FDA on-site audits;
Inform the FDA's official contacts to have a certain understanding of FDA regulations and work procedures, and to communicate directly with the FDA to facilitate timely feedback, companies can identify themselves or entrust the consulting agency responsible for daily communication with the FDA.
Cosmetic certification
Cosmetic Voluntary Registration Scheme (VCRP)
The FDA Office of Cosmetics and Colors has developed a voluntary voluntary registration program for cosmetics in response to the requirements of the cosmetics industry. The plan consists of two parts: voluntary registration of cosmetic manufacturers and declaration of cosmetic ingredients.
Benefits of participating in VCRP
Voluntary registration by the manufacturer and obtaining the registration number does not mean that the FDA approves the manufacturer or its products. The FDA does not allow the manufacturer to use the registration number or listing number to participate in the VCRP for commercial promotion; however, the manufacturer can directly obtain the following by participating in the VCRP. interest:
Get important information about cosmetic ingredients. The FDA enters all information obtained from the VCRP into a computer database. If a cosmetic ingredient currently in use is considered to be harmful and should be banned, FDA will notify the manufacturer or distributor of the product through the address book in the VCRP database. If your product is not in the registration database, FDA will not be able to notify you.
Avoid being detained when the product is recalled or imported due to ingredient problems. If the cosmetic manufacturer formulates the product in VCRP, as long as the FDA finds that the manufacturer uses unapproved color additives or other prohibited ingredients in the formulation, it will remind the manufacturer. In this way, the manufacturer can modify the product formulation before the product is imported or sold, thereby eliminating the risk of the product being recalled or detained due to the use of the improper component. Help retailers identify safety-conscious manufacturers. Retailers (such as department stores) sometimes ask if an FDA cosmetic company is registered with the FDA. Although registration does not imply FDA approval, it indicates that your product has been reviewed by the FDA and entered the government database. If the product formula you submitted is incomplete, or contains some kind of
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