US Food and Drug Administration

Monitoring agency of government health control

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synonym US Food and Drug Administration (U.S. Food and Drug Administration) generally refers to the U.S. Food and Drug Administration

FDA is short for Food and Drug Administration. FDA sometimes represents the US Food and Drug Administration. FDA by United States Congress I.e federal government Authorization is the highest law enforcement agency specialized in food and drug management, and is also a professional organization composed of doctors, lawyers, microbiologists, chemists, statisticians and other professionals committed to protecting, promoting and improving National health The government health control monitoring agency. Many countries promote and monitor the safety of their products by seeking and receiving the help of FDA.

Chinese name: Food and Drug Administration
Foreign name: FDA

Authorizing country: U.S.A
Date of establishment: 1906

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seven Related reports
eight Current leaders

Organization Introduction

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FDA is the Department of Health and Human Services of the United States Government（ DHHS ）One of the executive agencies set up in the subordinate Ministry of Public Health (PHS). FDA mainly includes testing and registration. Medical devices, cosmetics, food and drug products need to be tested FDA Registration , FDA registration can be directly registered in FDA Official website Apply on.

FDA was established in 1906; Before, there was no regulation on drugs in the United States, and drugs were sold through advertising; In 1938, it was required to prove the safety of drugs before they could be sold; In 1962, drugs were required not only to be safe but also to be proved effective before they could be sold.

Director of the Food and Drug Administration (FDA): food, drugs (including veterinary drugs), medical devices food additives , cosmetics, animal food and drugs, alcohol content less than 7% Wine Beverage and electronic products Supervision and inspection ； The product is in use or Consumption process Testing, inspection and certification of the impact of ionizing and non-ionic radiation generated in on human health and safety items. According to the regulations, the above products can be sold on the market only after they have passed the FDA inspection and proved to be safe. FDA has the right to inspect the manufacturer and sue the violators.

Center for Food Safety and Practical Nutrition (CFSAN)

The center is the department with the largest workload of FDA. It is responsible for USDA All food safety in the United States except meat, poultry and eggs. The Center for Food Safety and Nutrition is committed to reducing foodborne diseases And promote food safety. And promote various plans, such as the promotion and implementation of HACCP plan.

The functions of the center include: ensuring the safety of substances and pigments added in food; Ensure the safety of food and ingredients developed through biotechnology; Be responsible for the management of correctly labeled food (such as ingredients, nutrition and health statements) and cosmetics; Formulate corresponding policies and regulations to manage dietary supplement 、 Baby food Formulas and Medical food ； Ensure the safety of cosmetic ingredients and products, and ensure the correct identification; Supervise and standardize the after-sales behavior of the food industry; conduct Consumer education And behavior expansion; Cooperation projects with state and local governments; Coordination International Food Standards And safety, etc.

Center for Drug Evaluation and Research (CDER)

The center aims to ensure that prescription drugs and over-the-counter drugs To evaluate the safety and effectiveness of new drugs before they are launched, and supervise more than 10000 kinds of drugs sold on the market to ensure that the products meet the constantly updated highest standards. At the same time, the center also supervises the authenticity of drug advertisements on television, radio and publications. Strictly supervise drugs and provide consumers with accurate and safe information.

Equipment safety and Radiation Center for Health Protection (CDRH)

The center is responsible for ensuring the safety and effectiveness of newly marketed medical devices. Because more than 20000 enterprises around the world produce products from Blood glucose monitor reach Artificial heart valve And more than 80000 kinds of medical devices. These products are closely related to human life, so the center also supervises after-sales services nationwide. For some elephants Microwave Oven , TV sets, mobile phones and other products that can produce radiation, the center has also identified some corresponding safety standards 。

Biological Products Evaluation and Research Center (CBER)

The center supervises biological products that can prevent and treat diseases, so it is more complex than chemical comprehensive drugs, including the safety and effectiveness of blood, plasma, vaccines, etc scientific research 。

Veterinary Medicine Center (CVM)

The center supervises the food and medicine of animals to ensure the practicality, safety and effectiveness of these products in maintaining life and alleviating pain. Controlled by the US Food and Drug Administration Mad cow disease The work of is also carried out through the veterinary drug center's inspection of feed manufacturers. On December 19, 2007, the United States Food and Drug Administration announced the establishment of a Cloned animal Database, so that relevant authentication procedures can be effectively carried out. This database will become part of the National Animal Identification System, which is used to track all the animals in the United States from being raised on the farm to being put on the table livestock 。

Certification significance

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US FDA U.S. Department of State The Public Health Service Department of the Department of Health and Services is responsible for the management of all food, drugs, cosmetics and radiation instruments in the United States consumer protection Institutions. FDA not only collects and processes 80000 samples of products manufactured or imported in the United States for inspection, but also sends thousands of inspectors to 15000 factories overseas every year to confirm whether their activities comply with the laws and regulations of the United States.

Since 1990, the US FDA has worked closely with ISO and other international organizations to promote a series of innovative measures. Only the declared products that have been monitored at 143 key detection points after human use, monitored for 3 to 7 years for 2-3 million people, and completely passed the inspection will be issued with FDA certification.

Main impacts

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FDA has a tremendous impact in the United States and even the world, and is known as the "American health guardian". Drug and food traders all over the world love and fear it. Its reputation and professional level have won the trust of many experts and the general public. While its strict testing and evaluation provide good security, many drug and food traders also criticize it, accusing it of restricting invention and innovation and obstructing people's access to it Specific drug And lobbied Congress to reduce the authority of FDA, but this did not affect the sacred protection and performance of FDA's mission and responsibility. Up to now, FDA has become the golden shield of global food and drug consumers.

authentication

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food FDA Certification

FDA's regulatory agency for food, agricultural products and seafood is Food Safety And Nutrition Center（ CFSAN ）Its responsibility is to ensure that American food supplies are safe, clean, fresh and clearly labeled. The food imports supervised by the Center are 240 billion dollars annually, of which 15 billion belong to Imported food The main monitoring focuses of the Center include:

1. Food freshness;

2、 food additives ；

3. Food Biotoxin Other harmful ingredients;

4. Seafood safety analysis ；

5、 Food labeling ；

6. Follow up and warning after food marketing

according to US Congress Adopted in 2003 Anti Terrorism Law Food enterprises outside the United States must FDA Registration And notify FDA of the shipment at the time of export

Foreign food production and processing enterprises that must be registered with FDA under U.S. Public Law 107-188 are as follows:

1. Wine and liquor Drinks;

2. Infant and children's food;

3. Bread and pastry;

4. Beverage;

5、 candy Class (including Chewing gum ）；

6、 oatmeal And ready to eat cereals;

7、 cheese And cheese products;

8、 Chocolates And cocoa food;

9. Coffee and tea products;

10. Food pigment;

11. Regular diet food and medical food, meat succedaneum ；

12. Supplementary food (i.e. domestic health food vitamin Class A drugs and Chinese herbal medicine products);

13. Condiment;

14. Fish and seafood;

15. Materials, substances and products placed in food and in direct contact with food;

16. Food additives and safe ingredients;

17. Food aspartame ；

18. Fruit and fruit products;

19、 Edible gum , lactase Pudding And stuffing;

20. Ice cream and related food;

21. Imitation Dairy ；

22、 macaroni and noodle ；

23. Meat, meat products and poultry products;

24. Milk butter And dried milk products;

25. Dinner food and Marinade , sauce and special products;

26、 Dry Fruits and Nut ；

27. With shell Eggs and egg products ；

28、 a snack (flour, meat and vegetables);

29、 Pepper , special flavor and salt, etc;

30. Soup;

31、 soft drink And canned water;

32. Vegetables and vegetable products;

33、 Rape oil (including Olive oil ）；

34. Vegetable protein products (square meat food);

35、 Whole wheat food Food and starch processed with flour;

36. Products mainly or completely for human consumption;

FDA Certification of Medical Devices

FDA manages medical devices through the Center for Devices and Radiological Health (CDRH), which supervises the production, packaging and dealers of medical devices in compliance with laws operating activities 。 The range of medical devices is very wide, ranging from medical gloves to pacemaker Under the supervision of FDA, according to the medical use and possible harm to human body, FDA classifies medical devices into categories I, II and III. The higher the category, the more supervision

If the product is a novel invention that does not exist in the market, FDA requires the manufacturer to strictly Human experiment And there is convincing medical and statistical evidence to show that Effectiveness And security.

FDA certification of medical devices, including: manufacturer registration in FDA, product FDA registration, product listing registration (510 form registration), product listing review and approval (PMA review) medical care The following materials must be submitted for the label, technical transformation, customs clearance, registration and pre marketing report of the device:

(1) Completely packaged Finished products Five copies,

(2) Device structure drawing and Text description ,

(3) Performance and working principle of the device;

(4) Safety demonstration or test materials of the device,

（5） manufacturing process Introduction,

(6) Clinical trial summary,

（7） Product specification . If the device has radioactive properties or releases Radioactive material , must be described in detail

Factory and product registration of medical devices

FDA has a clear and strict definition of medical devices, which is as follows: "The so-called medical devices refer to the instruments, devices, tools, machinery, appliances, insertion tubes, in vitro reagents and others that meet the following conditions Related items , including components, parts or accessories: specifically listed in National Formulary or the Unite States Pharmacopeia or an appendix to both; Intended to be used for the diagnosis of animal or human diseases, or other physical conditions, or for the cure, mitigation and treatment of diseases; Expected impact on animals or human body Body function Or structure, but not through metabolism to achieve its main purpose ".

Only products that meet the above definition are considered as medical devices. Under this definition, not only various instruments and tools in hospitals, but also consumers can buy them in general stores Eyeglass frame , glasses, toothbrush and Massager etc. Fitness Equipment They are all under the management of FDA. It is slightly different from the recognition of medical devices in China.

According to different risk levels, FDA classifies medical devices into three categories (I, II, III), with the highest risk level of category III. FDA clearly stipulates the product classification and management requirements for each medical device,. If any kind of medical device wants to enter the US market, it must first clarify the classification and management requirements of the products applied for listing.

FDA has formulated many bills for medical devices, which are amended and supplemented from time to time, but there are not many basic bills, mainly including: federal Food, Drug and Cosmetic Act (FD&C Act, the basic act); Public Health Services Act; Fair Packaging and Labeling Act; Health and Safety Radiation control Act; Safe Medical Devices Act; Modernization Act. FDA has given a very detailed explanation of these acts, and has specific operational requirements. Before planning to enter the U.S. market, enterprises need to carefully evaluate the regulations and specific requirements related to their products (including different U.S Product standard Requirements).

After clarifying the above information, enterprises can start to prepare relevant application materials and apply to FDA for approval according to certain procedures. For any product, enterprises need to register and list products. For Class I products (accounting for about 47%) general control (General Control), most products only need to be registered, listed and implemented GMP Standardized, products can enter the U.S. market (very few of them are exempt from GMP, and very few of the reserved products need to submit 510 (K) applications to FDA, i.e. PMN (Premarket Notification)); For Class II products (accounting for about 46%), special control is implemented. After registration and listing, enterprises need to implement GMP and submit 510 (K) applications (very few products are 510 (K) exemptions); For Class III products (accounting for about 7%), pre marketing licensing is implemented. After registration and listing, enterprises must implement GMP and submit PMA (Premarket Application) applications to FDA (some Class III products are still PMN).

For Class I products, after the enterprise submits relevant materials to FDA, FDA only makes announcement and does not issue relevant certificates to the enterprise; For Class II and III devices, the enterprise must submit PMN or PMA. FDA will give the enterprise a formal market access approval letter (Clearance) at the same time of the announcement, that is, allow the enterprise to use its own name in the U.S. medical device market Direct sales Its products. As for whether to conduct on-site GMP assessment in the enterprise during the application process, FDA shall, according to the product risk level, management requirements and Market feedback And other comprehensive factors.

It can be seen from the above that most products can be approved for listing by FDA after enterprise registration, product listing, GMP implementation, or submission of 510 (K) application.

1.510 (K) document is also the document required by FDA for PMN. Because of its corresponding chapter 510 of FD&C Act, it is usually called 510 (K) document.

2. Substantial equivalence comparison (SE)

3.510 (K) Review procedure

Before application, it must be clear whether the product is recognized by FDA as a medical device, product category, management requirements, and the application job content ；

For the products applied for listing, check whether there is a US mandatory standard and whether the products meet the standard (generally, it is required that the testing agency Inspection report ）；

Before preparing 510 (K) application documents, it is necessary to consider whether it is really necessary to submit, when to submit, and what kind of 510 (K) application to submit: regular 510 (K), special 510 (K), simplified 510 (K);

The questions raised by FDA during the application process shall be answered in writing and in a timely manner;

The paper size of all data submitted to FDA shall be Letter Size (21.5cm X 29.7cm);

All data submitted to FDA shall be kept by the enterprise as a backup, because FDA will Electronic scanning Log in and destroy the application data, which will not be returned to the enterprise.

For a small number of products, FDA will conduct on-site GMP assessment for enterprises. Enterprises need to refer to the U.S. GMP management requirements and On site audit They should be equipped with appropriate ones who have a certain understanding of GMP and enterprises interpreter ；

The official contact person who informs FDA needs to have a certain understanding of FDA regulations and working procedures, and be able to communicate directly with FDA to facilitate timely feedback. The enterprise can specify that it or its entrusted consulting agency is responsible for daily communication with FDA.

Cosmetics FDA certification

Sample of FDA certificate for cosmetics

Voluntary Registration Scheme for Cosmetics（ VCRP ）

The FDA Office of Cosmetics and Colorants has developed a voluntary registration plan for cosmetics in response to the requirements of the cosmetics industry. The plan includes two parts: voluntary registration of cosmetics manufacturers and Cosmetic ingredients Declaration.

Benefits of participating in VCRP

The voluntary registration of the manufacturer and the obtaining of the registration number does not mean that FDA approves the manufacturer or its products, and FDA does not allow the manufacturer to use the registration number or listing number obtained by participating in VCRP for commercial publicity; However, manufacturers can directly obtain the following benefits by participating in VCRP:

Get important information about cosmetic ingredients. All the information FDA will get from VCRP Information input Computer database. If a cosmetic ingredient currently used is considered harmful and should be banned, FDA will mail list Notify the manufacturer or seller of the product. If your product is not in the registration database, FDA will not be able to notify you.

Avoid product recall or detention upon import due to composition problems. If the cosmetics manufacturer files the product formula in VCRP, as long as FDA finds that the manufacturer has used unapproved pigment additives or other prohibited ingredients in the formula, it will remind the manufacturer to pay attention. In this way, the manufacturer can modify the product formula before the product is imported or sold, thus eliminating the risk of product recall or detention due to the use of improper ingredients. Help retailers identify safety consciousness Manufacturer of. Retailers (e.g department store ）Sometimes ask FDA whether a cosmetics company has registered with FDA. Although registration does not mean FDA approval, it indicates that your product has been reviewed by FDA and entered into the government database. FDA will notify you if the product formula you submit is incomplete, or contains a banned ingredient or unapproved pigment additive.

The decision to collect samples is based on the nature of the product; FDA's key concerns; Past history of the product. FDA takes a physical sample and sends it to the FDA regional laboratory for analysis

If FDA finds that the sample meets the requirements, report to US Customs Send a "Release" to the importer notice "。

If FDA determines that the sample "violates FDCA and other relevant laws", it will send the "Notice of Detention and Hearing" to the US Customs and the case and the importer respectively. The notice shall specify the illegality and nature, and give the case and the importer 10 working days to provide evidence that the goods can be permitted.

The detained imported goods must be repaired, transported back or destroyed under the supervision of FDA or US Customs

A hearing is an opportunity for the importer to defend the imported goods or provide evidence to make the goods fit for entry after being trimmed.

If the case and underwriter If the consignor, importer or a designated representative does not reply to the notice, FDA will send a "refusal notice" to the U.S. Customs and the importer. Then the product in question is returned or destroyed.

If the case and the underwriter, owner, importer or a designated representative replied to the "Notice of Detention and Hearing" application FDA held a hearing on the detained products.

If the trade name provides evidence that the product meets the requirements, FDA will collect subsequent samples. After analysis, it is decided that the product is either released or refused entry.

FDA reviews the proposed trim procedure of the importer, and approves or disapproves it as appropriate. Once approved, FDA will conduct subsequent inspection/ Sample collection To determine its eligibility. If the sample is qualified, send the "Release Notice" to the US Customs and the importer. If the sample is unqualified, a "Notice of Rejection" will be issued.

Section 8 (C) of the FDCA requires the applicant to pay All expenses , including travel, daily expenses and wages of FDA officials or employees, in addition to the cost of updating labels or other measures to make seized goods conform to the provisions of the application (Form FDA 766). By submitting Form FDA - 766, the applicant agrees to pay all regulatory fees in accordance with current regulations.

FDA certification of drugs and biological products

FDA vs Pharmaceutical products There is a complete set of Certification procedure In order to ensure the safety and effectiveness of new drugs, the procedure is as follows:

one Research New Drug Request (IND):

When the pharmaceutical company submitted the IND to FDA, the FDA began to monitor the new drug. At this time, the human experiment of the new drug has not yet started. FDA mainly reviews the in vitro safety data and animals experimental data To determine whether the drug is safe enough to enter the human experiment stage

2. Human experiment:

The human experiment is divided into four stages Phase I mainly tests drug safety, main side effects, metabolic mechanism, etc., and the number of samples is generally less than 200

Phase II mainly tests the effectiveness of the drug to determine whether the drug can effectively act on the human body At the same time, the safety and side effects of drugs are also closely observed The number of samples in the second phase experiment is generally less than 300

If the second phase experiment is encouraging, a larger sample will be ready for testing, and the experiment will enter the third phase Phase III will include different age groups, different populations, and different dosage to comprehensively study the safety and effectiveness of drugs The number of samples in the third phase experiment varies from hundreds to thousands

Phase IV is mainly conducted after the approval of new drugs, mainly testing the long-term safety of drugs, new populations, etc

3. New Drug Application (NDA), Biological License Application (BLA)

When the pharmaceutical company has completed the human experiment and verified the safety and effectiveness of the new drug, it will formally submit an NDA application to FDA FDA reviews all animal and human experimental data, as well as drug metabolism mechanism data, and GMP data of drug production. If the data is incomplete or unreasonable, FDA will refuse to apply, otherwise FDA will complete the application in about 10 months and give approval or rejection opinions

Food Material FDA Certification

Food contact materials refer to all materials used in the process of processing, production, packaging, storage and transportation of food and that can come into contact with food. Common materials include various plastics, metals, ceramics, glass, bamboo and wood products, etc. The environmental protection and safety of these materials that can be contacted with food is directly related to the food safety and health of users. Therefore, the export of such products to the United States needs to be carried out in accordance with FDA standards Test certification 。

Common and FDA Certification of Food Contact Materials The test items are as follows:

■ Organic coating , requirements for metal and electroplated products U S. FDA CFR 21 175.300.

Deionized water Extraction method, 8% alcohol extraction method Heptane Leaching method

■ Paper product requirements U.S. FDA CFR 21 176.170

chloroform Soluble extracts (deionized water extraction, 8% alcohol extraction, 50% alcohol extraction, n-heptane extraction)

■ Wood requirements U S. FDA CFR 21 178.3800

Pentachlorophenol PCP

■ ABS requirements U S. FDA CFR 21 181.32 or 180.22.

Deionized water leaching, 3% acetic acid leaching, 8% alcohol leaching, n-heptane leaching

■ acrylic resin (Acrylic) Requirement U S. FDA CFR 21 177.1010

Total extract (in water, 8%, 50% alcohol fraction, heptane) deionized water, 8% alcohol

KMnO4 oxidizable extractive(in water,8%,50%alcohol fraction)

Ultraviolet-absorbing(in water,8%,50%alcohol fraction)

Ultraviolet-absorbing(in heptane fraction)

■ Food container seal ring ， Sealing gasket Requirements, such as silicon rubber Circle U.S. FDA CFR 21 177.1210

Chloroform soluble extract

■ EVA Requirements U.S. FDA CFR 21 177.1350

chloroform extraction

■ Trimer Cyanamide resin（ Melamine ）Requirements U.S. FDA CFR 21 177.1460

Chloroform soluble extract

■ Nylon plastic requirements U.S. FDA CFR 21 177.1500

Density, melting point hydrochloric acid In solubility , deionized water leaching, 95% alcohol leaching, ethyl acetate leaching, benzene leaching

■ PP Requirements U.S. FDA CFR 21 177.1520

Density, melting point N-Hexane Leaching method xylene Leaching method

■ PE , OP requirements U.S. FDA CFR 21 177.1520

Density, n-hexane leaching method, xylene leaching method

■ PC requirements U.S. FDA CFR 21 177.1580

water Reflux extraction 50% alcohol reflux extraction, n-heptane reflux extraction

■ PET requirements U.S. FDA CFR 21 177.1630

Chloroform soluble extracts (deionized water extraction, 8% alcohol extraction, 95% alcohol extraction, n-heptane extraction)

■ PS requirements U.S. FDA CFR 21 177.1640

styrene Monomer residue

■ Polysulfone resin requirements U.S. FDA CFR 21 177.1655

Deionized water leaching, 3% acetic acid leaching, 50% alcohol leaching, n-heptane leaching

■ Polyurethane resin（ PU ）Requirements U.S. FDA CFR 21 177.1680

Wear resistance test, deionized water leaching method, 8% alcohol leaching method

■ Styrene block polymer U.S. FDA CFR 21177.1810

Deionized water extraction, 50% alcohol reflux extraction, solubility, molecular weight Glass transition temperature

■ MMA, MBS requirements U.S. FDA CFR 21 177.1830

Non-volatile residue

KmnO4 oxidized water extractives

KmnO4 oxidized 8% ethanol extractives

UV absorbing water extractives

UV absorbing 8% ethanol extractives

UV absorbing n-heptane extractives

■ Urea formaldehyde resin (UF) Requirements U.S. FDA CFR 21 177.1900

Deionized water leaching, 8% alcohol leaching, n-heptane leaching

■ PVC Requirements U.S. FDA CFR 21 175.300

Deionized water leaching, n-heptane leaching, 8% alcohol leaching VCM Monomer residue

■ Polyester resin requirements U.S. FDA CFR 21 177.2420

Chloroform soluble extract

■ Rubber requirements（ SBS ,TPR, TPE ）Silicone and other elastomers U.S. FDA CFR 21 177.2600

Deionized water leaching method, n-hexane leaching method (only for fat food contact)

■ Requirements for silver plated products U.S. FDA CPG 7117.05

Lead extraction

■ Ceramics, glass Enamel ware Requirements U.S. FDA CPG 7117.06,07

Dissolved lead and cadmium test

■ Metal requirements U.S. FDA CFR 175.300&CPG 7117.05

Deionized water extraction, 8% alcohol extraction, n-heptane extraction, lead extraction

Luminaire requirements

1968 U.S. government The Radiation Control for Health and Safety Act was released. The purpose of this law is to protect the public from unnecessary radiation damage from electronic products. For this reason, FDA has formulated relevant performance standards for radiation of electronic products, and it is mandatory that radiation electronic products entering the U.S. market must comply with relevant performance standards. Radiant Sunlight 、 Ultraviolet lamp And high strength Mercury steam Discharge lamp It must meet the requirements of FDA. FDA's requirements for radiant lamps are mainly included in 21 CFR part 1040 of the U.S. federal regulations.

1. Inspection and supervision of product import and punishment for violations

The import inspection, supervision and administration of radioactive products in the United States are also controlled by its American food Drug management FDA). FDA requires foreign manufacturers of radioactive products to submit relevant materials to FDA before their products are sold to the United States. Then FDA assigns a 7-digit number, which is equivalent to the registration number of foreign manufacturers in FDA.

In addition to customs declaration, importers must also declare to FDA on FDA Form 2877 (Electronic Product Declaration Form) when importing radioactive products for customs clearance. In addition to the information about the manufacturer, importer and product, the declaration form also needs the registration number of the foreign manufacturer in FDA. If the declaration materials are incomplete or do not meet the requirements, they are directly rejected by FDA. Even if the customs approves the release, they cannot enter the US market for sales. In addition to reviewing the application materials, FDA also has the right to sample and inspect the imported products before or after they enter the market to check whether they really meet the mandatory requirements of relevant US regulations. FDA will strictly deal with the illegal products. FDA has two kinds of penalties: detain, return to foreign countries and destroy on the spot for illegal products. Similar to medical devices, there are also penalties for illegal electronic products“ Automatic detention ”System; For intentional violations or false reports,, Serious circumstances Of, according to the laws and regulations , can be fined, sentenced or both.

Traditional Chinese Medicine Certification

1. Herbs and other products should be divided into drugs and dietary supplements. If it is a drug, it must be approved by FDA before entering the US market; If it is a dietary supplement, it is not necessary to register with FDA or obtain its approval before entering the US market, but it must be ensured that Product safety And effectiveness, and comply with the relevant provisions of the FDA on the labeling of dietary supplements.

2. The labels of dietary supplements (in English) must be true and not misleading, and the words "diagnose, treat or prevent diseases" cannot be used. All dietary supplements must be labeled with "dietary supplements".

Agreement on Technical Barriers to Trade

The manufacturer can make some instructions about the product's function on the product label, but must indicate "the above contents have not been reviewed by FDA, and this product is not suitable for diagnosis, treatment or prevention of diseases" and other words. If there is a description of the product's role on the label, the manufacturer or distributor must notify FDA and provide relevant information within 10 days after the product is launched, but it is not necessary to seek the approval of FDA in advance.

For herbal products, it is necessary to specify the plant application part or the composition Plant extract Come out and wait for information.

If the nutrition content of the product is indicated on the label or the statement that the product may be related to disease and health is mentioned, the manufacturer or distributor must notify FDA at least 120 days before the product is listed and obtain its approval. If FDA considers that the submitted notice does not conform to relevant regulations after review, it will not approve it and will reply by letter as soon as possible within 120 days after receiving the notice. The manufacturer or distributor can modify the unapproved label and submit it to FDA for approval. In this case, the product cannot be marketed for at least 120 days after the notification is submitted to FDA.

3. Dietary supplements that appeared in the U.S. market after the enactment of the Dietary Supplement Health and Education Act (October 15, 1994) are all new dietary supplements. It must at least meet one of the following requirements: ① its ingredients originally exist in food without chemical modification; ② its ingredients have been used or have other established safety evidence to prove that its ingredients have appropriate safety under normal use. The manufacturer or distributor must notify FDA and provide safety data at least 75 days before the product is launched.

Dietary supplements that have been marketed in the United States before October 15, 1994, if they contain new ingredients, should also comply with the above requirements.

FDA shall reply within 75 days after receiving the notice, inform the number and file it. If there is any objection, FDA will reply Explain the reason 。 If the manufacturer or dealer does not receive a reply from FDA, they should contact FDA for information. For products without serial number, FDA will notify the customs Deduction And refuse to import.

4. FDA will not charge any fees when accepting food supplements.

Flight analysis

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flight Data analysis (Flight Data Analysis, referred to as "FDA")

With the support of FDA data, the following measures are taken to reduce the operation cost of Canada Airlines: control the takeoff of aircraft Pitch angle , Release Landing gear Timing, single engine taxiing, monitoring and shortening aircraft taxiing to Boarding gate Of waiting time . Adopt more reasonable Aircraft trim Etc; FDA is Engineering technology Provide data support for maintenance and timely discover aircraft system failure Monitoring system working condition Thereby reducing Aircraft maintenance cost 。 In addition, when new aircraft are introduced Airborne equipment The manufacturer negotiated to obtain more aircraft data parameters (Data Map file), and rich flight parameters established a strong foundation for comprehensive monitoring and in-depth analysis of aircraft operation.

fluorescein

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FDA fluorescein double Acetate , which is nonpolar Organic compound , it can enter and exit freely Protoplast Membrane. Because in viable protoplast cells esterase Under the action of esterase, FDA is rapidly decomposed and fluorescein is released. Fluorescein is a polar compound, which is difficult to penetrate cell membrane Will accumulate in cytoplasm Under blue excitation light, fluorescein emits yellow green fluorescence.

In the protoplasts without viability, the esterase activity is very low. Although FDA can freely enter and exit the protoplasts, it will not emit fluorescence.

Therefore, FDA has been considered as a method to identify cell activity Specificity Very strong indicator , which has been widely used in pollen 、 Suspension cell And protoplast viability.

Related reports

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In February 2019, an announcement was posted on the official website on the suspected illegal sales Alzheimer disease 17 domestic and foreign enterprises of the product sent 12 warning letters and 5 advice letters respectively. These enterprises involve more than 58 kinds of products, claiming to be able to prevent, treat or cure Alzheimer's disease and many other serious diseases and health conditions, which may actually be ineffective, unsafe or even hinder people from seeking appropriate diagnosis and treatment. FDA requires the enterprises involved to reply how to correct the violations within 15 days, and if they fail to correct the violations on time, they may face legal proceedings, resulting in product seizure or prohibition.^[1]

On June 10, 2021, it was reported that the US Food and Drug Administration (FDA) had only required one vaccination Injection Of New coronal vaccine Of quality guarantee period It will be extended from 3 months to 4.5 months, because millions of doses of unused vaccines will expire this month.^[2]

On December 22, 2021, the United States Food and Drug Administration approved the first oral drug that can be used urgently to treat COVID-19 infection, which is used to treat adults with mild to moderate COVID-19, children aged 12 years and above, and people with high risk of severe COVID-19 infection Group.^[3]

Current leaders

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Director: Robert Califf ^[4]

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