Avantages of Food and Drug Administration

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States

Department of Health and Human Services, one of the United States federal executive departments. The
FDA is responsible for protecting and promoting public health through the control and supervision of food
safety, tobacco products, dietary supplements, prescription and over-the-counterpharmaceutical
drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic
radiationemitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

Regional facilities
The FDA frequently works with other federal agencies, including the Department of Agriculture, Drug
Enforcement Administration, Customs and Border Protection, and Consumer Product Safety Commission.
Often local and state government agencies also work with the FDA to provide regulatory inspections and
enforcement action.

Scope and funding

The FDA regulates more than US$1 trillion worth of consumer goods, about 25% of consumer
expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60
billion in cosmetics and $18 billion in vitamin supplements. Much of these expenditures are for goods
imported into the United States; the FDA is responsible for monitoring imports.

Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act, (first passed in 1938
and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code. Other
significant laws enforced by the FDA include the Public Health Service Act, parts of the Controlled
Substances Act, the Federal Anti-Tampering Act, as well as many others. In many cases these
responsibilities are shared with other federal agencies

Regulatory programs
The programs for safety regulation vary widely by the type of product, its potential risks, and the
regulatory powers granted to the agency. For example, the FDA regulates almost every facet of
prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety
—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most
products with a set of published standards enforced by a modest number of facility inspections.

Regulation of food and dietary supplements

The regulation of food and dietary supplements by the U.S. Food and Drug Administration is governed by
various statutes enacted by the United States Congress and interpreted by the FDA. Pursuant to
the Federal Food, Drug, and Cosmetic Act ("the Act") and accompanying legislation, the FDA has
authority to oversee the quality of substances sold as food in the United States, and to monitor claims
made in the labeling about both the composition and the health benefits of foods.
The FDA subdivides substances that it regulates as food into various categories—including
foods, food additives, added substances (man-made substances that are not intentionally
introduced into food, but nevertheless end up in it), and dietary supplements. Specific standards
the FDA exercises differ from one category to the next. Furthermore, legislation had granted the
FDA a variety of means to address viola

Medications
The Center for Drug Evaluation and Research uses different requirements for the three main drug product
types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a
different manufacturer, uses different excipients or inactive ingredients, is used for a different purpose, or
undergoes any substantial change. The most rigorous requirements apply to new molecular entities:
drugs that are not based on existing medications.

New medications
New drugs receive extensive scrutiny before FDA approval in a process called a new drug
application (NDA). Critics, however, argue that the FDA standards are not sufficiently rigorous, allowing
unsafe or ineffective drugs 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 drug must be approved through
an NDA first. A drug that is approved is said to be "safe and effective when used as directed".

Generic drugs
Generic drugs are chemical equivalents of name-brand drugs whose patents have expired. In general,
they are less expensive than their name brand counterparts, are manufactured and marketed by other
companies and, in the 1990s, accounted for about a third of all prescriptions written in the United States.
[34]
 For approval of a generic drug, the U.S. Food and Drug Administration (FDA) requires scientific
evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally
approved drug.[35]This is called an "ANDA" (Abbreviated New Drug Application). As of 2012 80% of all
FDA approved drugs are available in generic form.

Over-the-counter drugs
Over-the-counter (OTC) drugs like aspirin are drugs and combinations that do not require a doctor's
prescription. The FDA has a list of approximately 800 approved ingredients that are combined in various
ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously
approved prescription drugs now deemed safe enough for use without a medical practitioner's supervision
like ibuprofen.

Ebola treatment
In 2014, the FDA added an Ebola treatment being developed by Canadian pharmaceutical company
Tekmira to the Fast Track program, but halted the phase 1 trials in July pending the receipt of more
information about how the drug works. This is seen as increasingly important in the face of a major
outbreak of the disease in West Africa that began in late March 2014 and continued as of August 2014.

Vaccines, blood and tissue products, and biotechnology

The Center for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the
safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines,
allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go
through a premarket approval process called a Biologics License Application (BLA), similar to that for
drugs.
The original authority for government regulation of biological products was established by the
1902 Biologics Control Act, with additional authority established by the 1944 Public Health Service Act.
Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well.
Originally, the entity responsible for regulation of biological products resided under the National Institutes
of Health; this authority was transferred to the FDA in 1972.

Medical and radiation-emitting devices

The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the
premarket approval of all medical devices, as well as overseeing the manufacturing, performance and
safety of these devices. 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 as implantable neurostimulators. CDRH
also oversees the safety performance of non-medical devices that emit certain types of electromagnetic
radiation. Examples of CDRH-regulated devices include cellular phones, airport baggage screening
equipment, television receivers, microwave ovens, tanning booths, and laser products.

Cosmetics
Cosmetics are regulated by the Center for Food Safety and Applied Nutrition, the same branch of
the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval
by the FDA unless they make "structure or function claims" that make them into drugs
(see Cosmeceutical). However, all color additives must be specifically FDA approved before
manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates
cosmetics labeling, and cosmetics that have not been safety  tested must bear a warning to that
effect.

Veterinary products
The Center for Veterinary Medicine (CVM) is the branch of the FDA that regulates food additives and
drugs that are given to animals.] CVM does not regulate vaccines for animals; these are handled by
the United States Department of Agriculture.
CVM's primary focus is on medications that are used in food animals and ensuring that they do not affect
the human food supply. The FDA's requirements to prevent the spread of bovine spongiform
encephalopathy are also administered by CVM through inspections of feed manufacturers.

Tobacco products
Since the Family Smoking Prevention and Tobacco Control Act became law in 2009, the FDA also has
had the authority to regulate tobacco products.
In 2009, Congress passed a law requiring color warnings on cigarette packages 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 in June 2011 and were scheduled to
be required to appear on packaging by September 2012. The implementation date is uncertain, due to
ongoing proceedings in the case 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 Fe
Natural Tobacco Company Inc. have filed suit in Washington, D.C. federal court claiming that the graphic
labels are an unconstitutional way of forcing tobacco companies to engage in anti-smoking advocacy on
the government's behalf.

Regulation of living organisms

Dr. Ronald Sherman permission to produce and market medical maggots for use in humans or other
animals as a prescription medical device. Medical maggots represent the first living organism allowed by
the Food and Drug Administration for production and marketing as a prescription medical device.
The FDA also requires milk to be pasteurized to remove bacteria