The Food and Drug Administration (FDA or USFDA) is a federal agencyof the United States Department of Health and Human Services, one of the UnitedStates federal executive departments. The FDA is responsible for protecting andpromoting public health through the control and supervision of food safety,tobacco products, dietary supplements, prescription and over-the-counterpharmaceutical drugs (medications), vaccines, biopharmaceuticals, bloodtransfusions, medical devices, electromagnetic radiation emitting devices(ERED), cosmetics, animal foods & feed and veterinary products.
Food certification
The Food Safety and Nutrition Center (CFASAN), the FDA's governingbody for food, agricultural and seafood, is responsible for ensuring that theAmerican food supply is safe, clean, fresh and well-labeled.Monitoringhighlights include:
1. Food freshness;
2. Food additives;
3. Other harmful ingredients of food biotoxin.
4. Seafood safety analysis;
5. Food labels;
6. Tracking and warning after food marketing
Food companies outside the United States must register with the FDAbefore exporting to the United States and notify the FDA of the shipment at thetime of export, according to the anti-terrorism law passed by the United StatesCongress in 2003.
According to the 107-188 public law of the United States, foreignfood production and processing enterprises that must be registered with FDA areas follows:
1.Wine and alcoholic beverages;
2. Food for infants and children;
3.Bread and pastry;
4.Beverage;
5.Candy (including gum);
6.Cereals and instant cereal.
7.Cheese and cheese products;
8.Chocolate and cocoa food;
9.Coffee and tea products;
10. Food colorants;
11.Weight loss regular food and medicinal food, meat substitutes;
12.Supplementary food (that is, domestic health food, vitamin drugsand Chinese herbal products);
13.Condiments;
14. Fish and seafood;
15.Materials and products that are placed in food and directlycontact with food;
16.Agents and safe ingredients food products;
17.Food substitute sugar;
18. Fruit and fruit products;
19.Edible gum, lactase, Boudin and stuffing;
20.Ice cream and related food;
21.Imitation dairy products;
22.Macaroni and noodles;
23. Meat, meat products and poultry products;
24.Milk, butter and dry milk products;
25.Dinner food and marinade, sauce and specialty products;
26.Nuts and nuts;
27.Shell eggs and egg products;
28.Dim sum (flour, meat and vegetables)
29.Chili, special taste and salt.
30. Soup;
31.Soft drinks and canned water;
32.Vegetables and vegetable products;
33.Rapeseed oil (including olive oil);
34.Vegetable protein products (meat type food);
35.Whole wheat food and flour processed food, starch and so on;
36.Main or all products for human consumption;
Medical devicecertification
The FDA administers medical devices through the Devices andRadiation Health Center (CDRH), which supervises the production, packaging, anddistribution of medical devices in compliance with the law.
The range of medical devices ranges from medical gloves to cardiacpacemakers, which are supervised by the FDA. According to the medical use andpossible harm to the human body, the FDA classifies medical devices intocategories I, II and III. The higher the category, the more supervision.
If the product is a novel invention that does not exist on themarket, the FDA requires manufacturers to conduct rigorous human trials withconvincing medical and statistical evidence of its effectiveness and safety.
The FDA certification of medical devices includes: the FDAregistration of the manufacturer, the FDA registration of the product, theregistration of the product on the market (510 forms), the approval of theproduct on the market (PMA examination), the labeling and technicaltransformation, customs clearance, registration, pre-marketing report of the medicaldevices, and the following materials must be submitted: (1) Five completepackaged finished products. (2) Instrument construction drawings and theirwritten instructions; (3) Instrument performance and working principle; (4)Instrument safety demonstration or test materials; (5) Brief introduction ofmanufacturing process; (6) Summary of clinical trials; (7) Productspecifications. If the instrument has radioactive energy or radioactivesubstances, it must be described in detail.
Medications
The Center for Drug Evaluation and Research uses differentrequirements for the three main drug product types: new drugs, generic drugs,and over-the-counter drugs. A drug is considered "new" if it is madeby a different manufacturer, uses different excipients or inactive ingredients,is used for a different purpose, or undergoes any substantial change. The mostrigorous requirements apply to new molecular entities: drugs that are not basedon existing medications.
New medications
New drugs receive extensive scrutiny before FDA approval in aprocess called a new drug application (NDA). Critics, however, argue that theFDA standards are not sufficiently rigorous, allowing unsafe or ineffectivedrugs to be approved. New drugs are available only by prescription by default.A change to over-the-counter (OTC) status is a separate process, and the drugmust be approved through an NDA first. A drug that is approved is said to be"safe and effective when used as directed".
Some very rare limited exceptions to this multi-step processinvolving animal testing and controlled clinical trials can be granted out ofcompassionate use protocols, as was the case during the 2015 Ebola epidemicwith the use, by prescription and authorization, of ZMapp and otherexperimental treatments, and for new drugs that can be used to treatdebilitating and/or very rare conditions for which no existing remedies ordrugs are satisfactory, or where there has not been an advance in a long periodof time. The studies are progressively longer, gradually adding moreindividuals as they progress from stage I to stage III, normally over a periodof years, and normally involve drug companies, the government and itslaboratories, and often medical schools and hospitals and clinics. However, anyexceptions to the aforementioned process are subject to strict review andscrutiny and conditions, and are only given if a substantial amount of researchand at least some preliminary human testing has shown that they are believed tobe somewhat safe and possibly effective.
Advertising and promotion
The FDA's Office of Prescription Drug Promotion reviews andregulates prescription drug advertising and promotion through surveillanceactivities and issuance of enforcement letters to pharmaceutical manufacturers.Advertising and promotion for over-the-counter drugs is regulated by theFederal Trade Commission.
The drug advertising regulation contains two broad requirements: (1)a company may advertise or promote a drug only for the specific indication ormedical use for which it was approved by FDA. Also, an advertisement mustcontain a "fair balance" between the benefits and the risks (sideeffects) of a drug.
The term off-label refers to drug usage for indications other thanthose approved by the FDA.
Postmarket safetysurveillance
After NDA approval, the sponsor must review and report to the FDAevery patient adverse drug experience it learns of. They must report unexpectedserious and fatal adverse drug events within 15 days, and other events on aquarterly basis. The FDA also receives directly adverse drug event reportsthrough its MedWatch program. These reports are called "spontaneousreports" because reporting by consumers and health professionals isvoluntary.
While this remains the primary tool of postmarket safetysurveillance, FDA requirements for postmarketing risk management areincreasing. As a condition of approval, a sponsor may be required to conductadditional clinical trials, called Phase IV trials. In some cases, the FDArequires risk management plans ("Risk Evaluation and MitigationStrategy" or "REMS") for some drugs that require actions to betaken to ensure that the drug is used safely. For example, thalidomide cancause birth defects but has uses that outweigh the risks if men and womentaking the drugs do not conceive a child; a REMS program for thalidomidemandates an auditable process to ensure that people taking the drug take actionto avoid pregnancy; many opioid drugs have REMS programs to avoid addiction anddiversion of drugs. There is also a REMS program called iPLEDGE for the drug,isotretinoin.
Generic drugs
Generic drugs are chemical equivalents of name-brand drugs whosepatents have expired. In general, they are less expensive than their name brandcounterparts, are manufactured and marketed by other companies and, in the1990s, accounted for about a third of all prescriptions written in the UnitedStates. For approval of a generic drug, the U.S. Food and Drug Administration(FDA) requires scientific evidence that the generic drug is interchangeablewith or therapeutically equivalent to the originally approved drug. This iscalled an "ANDA" (Abbreviated New Drug Application). As of 2012 80%of all FDA approved drugs are available in generic form.
Generic drug scandal
In 1989, a major scandal erupted involving the procedures used bythe FDA to approve generic drugs for sale to the public. Charges of corruptionin generic drug approval first emerged in 1988, in the course of an extensivecongressional investigation into the FDA. The oversight subcommitee of theUnited States House Energy and Commerce Committee resulted from a complaintbrought against the FDA by Mylan Laboratories Inc. of Pittsburgh. When itsapplication to manufacture generics were subjected to repeated delays by theFDA, Mylan, convinced that it was being discriminated against, soon began itsown private investigation of the agency in 1987. Mylan eventually filed suitagainst two former FDA employees and four drug-manufacturing companies,charging that corruption within the federal agency resulted in racketeering andin violations of antitrust law. "The order in which new generic drugs wereapproved was set by the FDA employees even before drug manufacturers submittedapplications" and, according to Mylan, this illegal procedure was followedto give preferential treatment to certain companies. During the summer of 1989,three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch)pleaded guilty to criminal charges of accepting bribes from generic drugsmakers, and two companies (Par Pharmaceutical and its subsidiary QuadPharmaceuticals) pleaded guilty to giving bribes.
Furthermore, it was discovered that several manufacturers hadfalsified data submitted in seeking FDA authorization to market certain genericdrugs. Vitarine Pharmaceuticals of New York, which sought approval of a genericversion of the drug Dyazide, a medication for high blood pressure, submittedDyazide, rather than its generic version, for the FDA tests. In April 1989, theFDA investigated 11 manufacturers for irregularities; and later brought thatnumber up to 13. Dozens of drugs were eventually suspended or recalled bymanufacturers. In the early 1990s, the U.S. Securities and Exchange Commissionfiled securities fraud charges against the Bolar Pharmaceutical Company, amajor generic manufacturer based in Long Island, New York.
Over-the-counter drugs
Over-the-counter (OTC) drugs like aspirin are drugs and combinationsthat do not require a doctor's prescription. The FDA has a list ofapproximately 800 approved ingredients that are combined in various ways tocreate more than 100,000 OTC drug products. Many OTC drug ingredients had beenpreviously approved prescription drugs now deemed safe enough for use without amedical practitioner's supervision like ibuprofen.
Ebola treatment
In 2014, the FDA added an Ebola treatment being developed byCanadian pharmaceutical company Tekmira to the Fast Track program, but haltedthe phase 1 trials in July pending the receipt of more information about howthe drug works. This is seen as increasingly important in the face of a majoroutbreak of the disease in West Africa that began in late March 2014 andcontinued as of August 2014.
Vaccines, blood and tissueproducts, and biotechnology
FDA scientist prepares blood donation samples for testing
The Center for Biologics Evaluation and Research is the branch ofthe FDA responsible for ensuring the safety and efficacy of biologicaltherapeutic agents.[43] These include blood and blood products, vaccines,allergenics, cell and tissue-based products, and gene therapy products. Newbiologics are required to go through a premarket approval process called aBiologics License Application (BLA), similar to that for drugs.
The original authority for government regulation of biologicalproducts was established by the 1902 Biologics Control Act, with additionalauthority established by the 1944 Public Health Service Act. Along with theseActs, the Federal Food, Drug, and Cosmetic Act applies to all biologicproducts, as well. Originally, the entity responsible for regulation ofbiological products resided under the National Institutes of Health; thisauthority was transferred to the FDA in 1972.
Medical andradiation-emitting devices
The Center for Devices and Radiological Health
The Center for Devices and Radiological Health (CDRH) is the branchof the FDA responsible for the premarket approval of all medical devices, aswell as overseeing the manufacturing, performance and safety of thesedevices.[44] The definition of a medical device is given in the FD&C Act,and it includes products from the simple toothbrush to complex devices such asimplantable neurostimulators. CDRH also oversees the safety performance ofnon-medical devices that emit certain types of electromagnetic radiation. Examplesof CDRH-regulated devices include cellular phones, airport baggage screeningequipment, television receivers, microwave ovens, tanning booths, and laserproducts.
CDRH regulatory powers include the authority to require certaintechnical reports from the manufacturers or importers of regulated products, torequire that radiation-emitting products meet mandatory safety performancestandards, to declare regulated products defective, and to order the recall ofdefective or noncompliant products. CDRH also conducts limited amounts ofdirect product testing.
"FDA-Cleared" vs"FDA-Approved"
Clearance requests are for medical devices that prove they are"substantially equivalent" to the predicate devices already on themarket. Approved requests are for items that are new or substantially differentand need to demonstrate "safety and efficacy", for example it may beinspected for safety in case of new toxic hazards. Both aspects need to beproved or provided by the submitter to ensure proper procedures are followed.
Cosmetics
Cosmetics are regulated by the Center for Food Safety and AppliedNutrition, the same branch of the FDA that regulates food. Cosmetic productsare not, in general, subject to premarket approval by the FDA unless they make"structure or function claims" that make them into drugs (seeCosmeceutical). However, all color additives must be specifically FDA approvedbefore manufacturers can include them in cosmetic products sold in the U.S. TheFDA regulates cosmetics labeling, and cosmetics that have not been safetytested must bear a warning to that effect.
Though the cosmetic industry is predominantly responsible inensuring the safety of its products, the FDA also has the power to intervenewhen necessary to protect the public but in general does not require pre-marketapproval or testing. Companies are required to place a warning note on theirproducts if they have not been tested. Experts in cosmetic ingredient reviewsalso play a role in monitoring safety through influence on the use ofingredients, but also lack legal authority. Overall the organization hasreviewed about 1,200 ingredients and has suggested that several hundred berestricted, but there is no standard or systemic method for reviewing chemicalsfor safety and a clear definition of what is meant by 'safety' so that allchemicals are tested on the same basis.
Veterinary products
The Center for Veterinary Medicine (CVM) is the branch of the FDAthat regulates food additives and drugs that are given to animals. CVM does notregulate vaccines for animals; these are handled by the United StatesDepartment of Agriculture.[citation needed]
CVM's primary focus is on medications that are used in food animalsand ensuring that they do not affect the human food supply. The FDA's requirementsto prevent the spread of bovine spongiform encephalopathy are also administeredby CVM through inspections of feed manufacturers.[citation needed]
Tobacco products
Since the Family Smoking Prevention and Tobacco Control Act becamelaw in 2009, the FDA also has had the authority to regulate tobacco products.
In 2009, Congress passed a law requiring color warnings on cigarettepackages and on printed advertising, in addition to text warnings from the U.S.Surgeon General.
The nine new graphic warning labels were announced by the FDA inJune 2011 and were scheduled to be required to appear on packaging by September2012. The implementation date is uncertain, due to ongoing proceedings in thecase of R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration. R.J.Reynolds, Lorillard, Commonwealth Brands Inc., Liggett Group LLC and Santa FeNatural Tobacco Company Inc. have filed suit in Washington, D.C. federal courtclaiming that the graphic labels are an unconstitutional way of forcing tobaccocompanies to engage in anti-smoking advocacy on the government's behalf.
A First Amendment lawyer, Floyd Abrams, is representing the tobaccocompanies in the case, contending requiring graphic warning labels on a lawfulproduct cannot withstand constitutional scrutiny. The Association of NationalAdvertisers and the American Advertising Federation have also filed a brief inthe suit, arguing that the labels infringe on commercial free speech and couldlead to further government intrusion if left unchallenged. In November 2011,Federal judge Richard Leon of the U.S. District Court for the District ofColumbia temporarily halted the new labels, likely delaying the requirementthat tobacco companies display the labels. The U.S. Supreme Court ultimatelycould decide the matter.
In July 2017, the FDA announced a plan that would reduce the currentlevels of nicotine permitted in tobacco cigarettes.
Regulation of livingorganisms
With acceptance of premarket notification 510(k) k033391 in January2004, the FDA granted Dr. Ronald Sherman permission to produce and marketmedical maggots for use in humans or other animals as a prescription medicaldevice. Medical maggots represent the first living organism allowed by the Foodand Drug Administration for production and marketing as a prescription medicaldevice.
In June 2004, the FDA cleared Hirudomedicinalis (medicinal leeches)as the second living organism to be used as a medical device.
The FDA also requires milk to be pasteurized to remove bacteria.
FDA product certification application process
1, the importer or agent will submit the declaration form to theCustoms at the port of entry within five days of arrival of the goods.
2. The food and Drug Administration (FDA) is informed of the entryof regulatory food through the following channels
A copy of customs declaration form (CF 3461, CF 3461ALT, CF 7501 orits replacement).
A copy of commercial invoice.
Responsible for the responsibility, tax and acceptance penalty.
3. The Food and Drug Administration examines the importer's entrydeclaration form to determine whether physical inspection, dock inspection orsampling inspection is necessary.
4A, decided not to take the examination. The food and DrugAdministration sent a letter to the US Customs and importer, "yes".For the food and drug administration, the goods were released.
4B, decided to draw the following checks according to the followingitems:
The nature of the goods;
The priorities of the food and Drug Administration and the historyof the commodity.
The food and Drug Administration issued a "samplingnotice" to us customs and importers. The goods must remain intact untilfurther notice. After sampling, the importer can move the goods to otherterminals or warehouses (for details, please contact the U.S. Customs).
5, the food and drug administration obtained physical samples.Samples were sent to the food and drug administration district laboratory forlaboratory analysis.
6A. The Food and Drug Administration (FDA) confirms that the samplesmeet the requirements after analysis, and the FDA issues "notices" toU.S. Customs and importers.
6B, the food and Drug Administration analyzed that the sampleappeared to be contrary to the FD&C act and other related laws. The Foodand Drug Administration signs with the U.S. Customs and Importers; detains andhears notices "which state the nature of the violation and give theimporter ten working days to state the reasons for accepting the goods.
This hearing is the only opportunity for the importer to defendand/or provide evidence for the legitimate entry of the import.
7A, consignee, actual shipper, importer or his designatedrepresentative reacts to the "detention and hearing notice". Oral orwritten testimony is made as to whether the goods can be received.
7B. The consignee, the actual shipper, the importer or hisdesignated representative neither responds to the detention and hearing noticenor requests an extension of the hearing period.
8A, the food and Drug Administration will hold a hearing on whetherthe product can be received. This hearing is the opportunity to presentrelevant affairs, and is limited to providing relevant evidence.
8B, the food and Drug Administration issued a notice of refusal ofentry to importers. This is the same person or company who issued the "samplingnotice" to him. All received "sampling notice" and"detention and hearing notice" were issued a "refusal toenter" notice.
9A, the importer provides evidence to prove that the product meetsthe requirements. Provide sampling results that meet the published"contamination and disability standards" for human food tested inreliable laboratories.
9B, importers propose "improvement or other measures toauthorize (FDAFD766 form)" application. The form requires that adulteratedor mislabeled food be allowed to be re-labeled or other measures taken to makeit conform to the requirements, or to be converted into non-practical goods.Specific measures to make the food meet the requirements must be put forward.
9C, food and drug administration received approval from the USCustoms to export or destroy the consignment. The export or destruction of thegoods listed on the "rejection receipt" is conducted under theguidance of us customs.
10A, food and Drug Administration collected food samples processedto determine whether they met the standards.
10B, the food and drug administration examined the improvementprocedures put forward by importers. Indemnity for loss shall be concluded.
11A, the food and Drug Administration confirmed that the sample was"qualified". "Notice of release" marked "originaldetention, now released" to the US Customs and importers.
11B, the food and Drug Administration decided that the sample was"unqualified". Importers may submit an application for"Improvement or Other Measures Authorization" (see 9B), otherwise theFDA will issue a "Denial of Acceptance Notice" (see 8B).
11C, the food and Drug Administration approved the improvementprocedure for importers. The letter of application is awaiting approval fromthe food and Drug Administration for the release of the goods.
11D. If past experience shows that the proposed approach will notsucceed, the FDA will veto the applicant's improved procedures. The Food andDrug Administration will not consider the second and last request unless meaningfulimprovements are made to ensure a considerable likelihood of success. Theapplicant was informed on the form FDA FD 766.
12, importers complete all improvement procedures to inform the foodand drug administration that goods can be inspected or sampled.
13, the food and drug administration carries out subsequent checksand sampling to determine whether it meets the requirements for improvement.
14A, the food and Drug Administration analyzed the samples. Issue"Release Notice" to importers and US customs. FDA regulatory fees areestimated in the FDA FD790 table. The copy is sent to the US customs. The USCustoms office is responsible for charging the total cost, including the costof customs officers.
14B, the food and Drug Administration confirmed that the sample wasstill unqualified. FDA regulatory fees are estimated in the FDA FD790 table.The US Customs office is responsible for collecting the total cost, includingthe cost of Customs personnel.
Importers can speed up the entry of goods!
It is lawful to determine the products to be imported before thegoods are shipped.
Please check the sample of imported food and verify the analysis ofthe factory. Although these analyses are not final, they may indicate that theplant is capable of producing satisfactory and legitimate products.
Before signing the freight contract, be familiar with the legalrequirements of the food and drug administration.
Request for food and drug administration area at your port of entry.
