X-Nico

68 unusual facts about Food and Drug Administration


1989 Chilean grape scare

No additional contaminated fruit was found, but the United States Food and Drug Administration banned the import of Chilean fruit and warned people not to eat grapes or Chilean fruit despite the fact investigators found no traces of cyanide in any other fruit shipped from Chile to Philadelphia.

2008 Chinese heparin adulteration

In March 2008, major recalls of heparin, a substance widely used as an injectable anticoagulant, were announced by the U.S. Food and Drug Administration (FDA) due to contamination of the raw heparin stock imported from China.

Advertising agency

These agencies distinguish themselves through an understanding of the strict labeling and marketing guidelines mandated by the U.S. Food and Drug Administration (FDA) and industry group guidelines, notably ADVAMED and PHARMA.

Agoranomos

The term is still in use today in modern Greece (Αγορονομία — Agoranomía), for the analogous in U.S. Center for Food Safety and Applied Nutrition, which is a branch of the Food and Drug Administration).

Alcoholic beverages in Oregon

In 2008, the U.S. Food and Drug Administration determined that absinthe was legal, though it had been understood to be illegal for about 80 years.

Andrew Caster

Caster is considered a pioneer in the field of Lasik surgery, being one of twenty doctors who got the LASIK procedure approved by the FDA.

Avenanthramide

In 1978 the U.S. Food and Drug Administration (FDA) external review panel noted that colloidal oatmeal was safe and effective for the symptomatic relief of dry skin and itching.

Breast Men

The film very loosely tracks the history of the real-life breast implant phenomenon, from its radical introduction through its incredible popularity, through the controversial link of its silicone base to various types of illnesses and cancers (culminating in the Food and Drug Administration's moratorium on use of silicone in breast implants, leading the industry to utilize saline ones, instead).

Cape May – Lewes Ferry

Although the buffet was shut down in 2000 after U.S. Food and Drug Administration inspectors found numerous violations in the galleys of all five vessels, the ship remains an attraction.

Carr Collins, Sr.

Sales reputedly reached $3 million a year, but then the Food and Drug Administration declared the product (and numerous similar products) fraudulent.

Chun-Su Yuan

In 2008, the Food and Drug Administration (FDA) approved methylnaltrexone (Relistor) for opioid-induced constipation in advanced illness patients.

Claudia Goldin

Goldin and Katz noted that the birth control pill was approved by the Food and Drug Administration in 1960 for use by married women.

Conus magus

Discovered by Dr. Baldomero Olivera at University of Utah, it was developed for treatment of chronic and intractable pain caused by AIDS, cancer, neurological disorders and other maladies, and was approved by the U.S. Food and Drug Administration in December 2004 under the name Prialt.

Cytarabine

It was approved by the United States Food and Drug Administration in June 1969, and was initially marketed in the U.S. by Upjohn under the trade name Cytosar-U.

David L. Huber

Huber received the Commissioner's Special Citation, United States Food and Drug Administration, in recognition of distinguished performance in litigation.

Drug coupon

As of 2008, the U.S. Food and Drug Administration (FDA) was planning a study to see if coupons make patients overlook drug risks and side effects in their effort to save money.

Fred Shank

Fred R. Shank was the Director of the Center for Food Safety and Applied Nutrition of the Food and Drug Administration for nearly ten years before he became Senior Advisor to the Commissioner for External Academic Affairs in January 1998.

Gambian pouched rat

In 2003, the United States' CDC and FDA issued an order preventing the importation of the rodents following the first reported outbreak of monkeypox.

Gang run printing

The U.S. Food and Drug Administration (FDA) warns to be aware of the potential of foreign packages, which may come from gang printing at the package supplier.

GEC Medical

The merged company as Picker International had the first MRI scanner approved by the U.S. Food and Drug Administration (FDA) on the US market.

GrammaTech

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health uses it to detect defects in fielded medical devices.

Greenfield Belser

In 1992, Burkey Belser was contacted by David Aaron Kessler's staff at the U.S. Food and Drug Administration to help with the Nutrition Facts label because of his prior success designing the EnergyGuide that appears on all major appliances in the United States.

HIRF

The U.S. Food and Drug Administration (FDA), and U.S. Federal Communications Commission (FCC) set limits for the amounts of Radio Frequency Energy exposure permitted in a standard work-day.

Hisamitsu Pharmaceutical

Hisamitsu has developed the only over-the-counter transdermal patches approved by the U.S Food and Drug Administration (FDA).

IPI-926

Depending on when a Hh inhibiting compound is approved by the U.S. Food and Drug Administration (FDA), there may be a perceived need for one to be differentiated over another for marketing purposes, which could lead to different nomenclature (e.g., a Hhi or an agonist of Smo).

Ismael Valenzuela

Rosa Delia Valenzuela had been taking the doctor-prescribed drug Rezulin that a few months later was withdrawn from the market when the U.S. Food and Drug Administration concluded that Rezulin use had "possibly or probably" resulted in 90 liver failures, including 63 deaths and seven nonfatal organ transplants.

Jane Akre

In 1997, Wilson and Akre began work on a story regarding the agricultural biotechnology company Monsanto and recombinant bovine growth hormone (rBGH), a milk additive that had been approved for use by the Food and Drug Administration but also blamed for a number of health issues.

JLF

The raid wasn't due however to the fact that JLF was selling analogues of then illegal drugs, but rather it was a part of a larger Food and Drug Administration (FDA) crackdown against a large group of herbal medicine providers.

John F. Kerin

For 7 years he was a principal investigator for conducting international multi-centre Food and Drug Administration regulated clinical trials for assessing the safety and efficacy of reproducive technology.

John Henry Schwarz

She won FDA approval for a placebo-controlled pilot study on 50 veterans.

Kittie Doswell

Ms. Doswell later began a career with the U.S. Food and Drug Administration in 1985, serving as a seafood inspector in FDA's Los Angeles District, San Pedro, California.

Langostino

In the United States, the Food and Drug Administration allows "langostino" as a market name for three species in the family Galatheidae: Cervimunida johni, Munida gregaria, and Pleuroncodes monodon.

Lasers and aviation safety

In the U.S., any use of lasers in a show or display requires pre-approval from the FDA Center for Devices and Radiological Health.

Linda Andre

Linda Andre is an American psychiatric survivor activist and writer, living in New York City, who is the director of the Committee for Truth in Psychiatry (CTIP), an organization founded by Marilyn Rice in 1984 to encourage the U.S. Food and Drug Administration (FDA) to regulate ECT (electroconvulsive therapy) machines.

Middle-of-the-night insomnia

Middle-of-the-night insomnia is often treated with medication, although currently Intermezzo (zolpidem tartrate sublingual tablets) is the only Food and Drug Administration-approved medication specifically for treating MOTN awakening.

Monograph

In the context of Food and Drug Administration (FDA) regulation, monographs represent published standards by which the use of one or more substances is automatically authorized.

Mutual Pharmaceutical Co. v. Bartlett

The Federal Food, Drug and Cosmetic Act (FDCA) requires that all drug manufactures gain approval from the Food and Drug Administration (FDA) before engaging in interstate commerce.

Nambé

The Food and Drug Administration (FDA) has declared Nambé safe for cooking and serving.

Neural tube defect

In 1996, the United States Food and Drug Administration published regulations requiring the addition of folic acid to enriched breads, cereals, flour and other grain products.

No, They Can't

The book gives several examples of government intervention: trade barriers, food and medical regulation, the education system, labor unions, gun control, minimum wage laws, the war on drugs, and advocates of universal health care.

Operation Snow White

They repeated their actions from the previous week, copying another foot of documents from the District of Columbia Police Department as well as the Food and Drug Administration.

Operation Whitecoat

According to USAMRIID, the Whitecoat operation contributed to vaccines approved by the U.S. Food and Drug Administration (FDA) for yellow fever and hepatitis, and investigational drugs for Q fever, Venezuelan equine encephalitis, Rift Valley fever, and tularemia.

Patent infringement under United States law

There is safe harbor for research conducted for "purely philosophical" inquiry, but research directed to commercial purposes has no safe harbor - unless the research is directed toward obtaining approval of the Food and Drug Administration (FDA) for introduction of a generic version of a patented drug (see Research exemption and Hatch-Waxman Act).

Paul S. Berry

He performed the viral load testing for Merck data submission to the U.S. Food and Drug Administration for approval of Crixivan.

Pierre Deniker

After Deniker's observations, they sought and received FDA approval in 1954 to market Thorazine for the treatment of schizophrenia.

Risk panel

The Food and Drug Administration also has a risk panel, a 15-member advisory panel to educate consumers about the risks and benefits of drugs, devices and vaccines.

SAFE-BioPharma Association

In essence, it allows officials in Health and Human Services, the Food and Drug Administration, Department of Defense, and other government agencies to trust the origins of electronic documents received from corporate managers, physicians, clinical researchers, etc. who are credentialed to digitally sign documents with SAFE-BioPharma digital signatures.

Serial number

In 2009 the U.S. FDA published draft guidance for the pharmaceutical industry to use serial numbers on prescription drug packages.

Sex effects of water pollution

The Food and Drug Administration (FDA) states in its review of water pollution that many contaminants survive wastewater treatment and biodegradation, and are detectable in the environment.

Susan Mokotoff Reverby

From 1993–1997 she served as the consumer representative on the U.S. Food and Drug Administration’s Obstetrics and Gynecology Devices Advisory Panel.

Sustainable Oils

Sustainable Oils is a Seattle-based renewable fuels company specializing in the research and production of Camelina, the only advanced biofuels feedstock with United States Department of Agriculture, Environmental Protection Agency, and Food and Drug Administration (FDA) regulatory approvals.

T3 Technion Technology Transfer

Having won U.S. Food and Drug Administration approval, the drug is now marketed world-wide as AzilectTM.

TalkPoint

TalkPoint also hosts www.FDAAdvisoryCommittee.com which provides access to the U.S. Food and Drug Administration (FDA) Advisory Committee meetings.

Term of patent in the United States

The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) of 1984 provides patent holders on approved patented products with an extended term of protection under the patent to compensate for the delay in obtaining Food and Drug Administration (FDA) approval.

Terri Crawford Hansen

As a member of the Association of Health Care Journalists, she requested with other journalists that the U.S. Food and Drug Administration (FDA) end current practices that restrict the public's access to health information.

Theodore S. Weiss

They also found that the U.S. Food and Drug Administration (FDA) failed to remove several drugs already known to be carcinogens.

Tomalley

The U.S. Food and Drug Administration then issued an advisory against consuming tomalley from American lobster found anywhere in the Atlantic Ocean.

Tomas J. Philipson

He served in the second Bush Administration as the senior economic advisor to the head of the Food and Drug Administration (FDA) during 2003-04 and subsequently as the senior economic advisor to the head of the Centers for Medicare and Medicaid Services (CMS) in 2004-05.

Truth In Aging

Many of the ingredients that they list to be potentially toxic have been found safe by the U.S. Food and Drug Administration (FDA).

United States Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies

This subcommittee has jurisdiction over the budget for the United States Department of Agriculture, Rural Development, and the Food and Drug Administration.

This subcommittee has jurisdiction over the Department of Agriculture discretionary spending (does not include the Food Stamp Program or farming subsidies that are mandatory spending), as well as food safety programs at the Food and Drug Administration and foreign agriculture assistance programs.

United States Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies

Certain agencies within Health and Human Services are handled by separate subcommittees, such as the Indian Health Service (Interior Subcommittee) and the Food and Drug Administration (Agriculture Subcommittee).

Victoria Hale

Her past affiliations include the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, and Genentech.

Viva Cruiser

The Food and Drug Administration had the game taken off the internet, which was linked through ads on Forbes magazine's website (Forbes.com).

VTech

In November 2011, manufacturing capacity of VTech's CMS was increased by 40% and the manufacturing facility was enhanced to enable it to manufacture products with stringent safety and quality requirements, including those requiring U.S. Food and Drug Administration (FDA) approval.

W. Page Keeton

Keeton was the father of former Texas Comptroller and gubernatorial candidate Carole Keeton Strayhorn, and grandfather of Scott McClellan, former White House Press Secretary under U.S. President George W. Bush, and Mark McClellan, who headed the Centers for Medicare and Medicaid Services and was Commissioner of the Food and Drug Administration in the second Bush administration.

William Horwitz

Horwitz worked for the U.S. Food and Drug Administration (FDA) for 57 years until his retirement in 2000 and was head of the Association of Official Analytical Chemists for 24 years.

Winslow Carlton

In the final decade of his life, Winslow Carlton co-founded and served as president of Selcore Labs, where a new a-cellular pertussis vaccine was developed and approved by the U.S. Food and Drug Administration.


Anosmia

On June 16, 2009, the US Food and Drug Administration sent a warning letter to Matrixx Initiatives, manufacturer of an over-the-counter nasal spray for the common cold, Zicam.

Anthrax Vaccine Immunization Program

Thereafter it ran into Food and Drug Administration (FDA) and judicial obstacles (mainly concerning the methods and viability of the vaccine manufactured by BioPort, a subsidiary of Emergent BioSolutions Inc.).

Anticarcinogen

Health claims for anticarcinogens are regulated by various national and international organizations like the US Food and Drug Administration (FDA) and European Food Safety Authority (EFSA).

Boiron

The non-profit, educational organizations Center for Inquiry (CFI) and the associated Committee for Skeptical Inquiry (CSI) have petitioned the U.S. Food and Drug Administration (FDA), criticizing Boiron for misleading labeling and advertising of Oscillococcinum.

Bosutinib

Bosutinib received US FDA and EU European Medicines Agency approval on September 4, 2012 and 27 March, 2013 respectively for the treatment of adult patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy.

Bovine somatotropin

Four large pharmaceutical companies, Monsanto, American Cyanamid, Eli Lilly, and Upjohn, developed commercial rBST products and submitted them to the US Food and Drug Administration (FDA) for approval.

Consumers for Dental Choice

Along with other advocacy groups, such as the International Academy of Oral Medicine and Toxicology, and legislators including Diane Watson (D-CA.) and Congressman Dan Burton (R-IN), Consumers for Dental Choice has called for an investigation of the Food and Drug Administration (FDA) for giving out false and deceptive information about mercury dental fillings, for not issuing warnings to pregnant women, and for failure to advise consumers that dental filling amalgam is mainly mercury.

Cooking oil

The United States Food and Drug Administration (FDA), the National Heart, Lung and Blood Institute and the American Heart Association (AHA) all have recommended limiting the intake of trans fats.

Drug Price Competition and Patent Term Restoration Act

Section 505(j) 21 U.S.C. 355(j) sets forth the process by which would-be marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval of the generic.

Flexi-bag

The materials used in the production of flexi-bags have to meet the US Food and Drug Administration, EU food-grade or German BGA standards.

Glembatumumab vedotin

In May 2010, the U.S FDA granted Fast Track designation to CDX-011 for the treatment of advanced, refractory or resistant GPNMB-expressing breast cancer.

Haw flakes

Haw flakes have been seized on several occasions by the United States Food and Drug Administration for containing Ponceau 4R (E124, Acid Red 18), an unapproved artificial coloring.

Herbert Stein

In Stein's reading, The Wealth of Nations could justify the Food and Drug Administration, the Consumer Product Safety Commission, mandatory employer health benefits, environmentalism and "discriminatory taxation to deter improper or luxurious behavior."

Lupus Center of Excellence at West Penn Allegheny Health System

Lupus Center of Excellence physicians also have appointments to advisory committees of the Food and Drug Administration, Alliance for Lupus Research, the Lupus Foundation of America, the American College of Rheumatology and the Arthritis Foundation.

MAKOplasty

MAKOplasty is a surgical procedure for partial knee or total hip arthroplasty using a RIO Robotic Arm Interactive Orthopedic System developed by MAKO Surgical Corp. RIO is cleared by the FDA for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT-based model of anatomy.

Maryland Route 650

The northbound direction gains a fourth lane ahead of passing the former Naval Ordnance Laboratory campus to the east, which is now occupied by the Food and Drug Administration.

Pandemic and All-Hazards Preparedness Reauthorization Act of 2013

Section 302, the “Authorization for Medical Products for Use in Emergencies” amends the Food and Drug Administration’s (FDA) current Emergency Use Authorization authority to enable the FDA to prepare for and prevent a public health emergency rather than simply responding to it.

PointCross

The platform includes analytics decision support, collaborative research, and development solutions for drug safety in the Pharma industry and the U.S. Food and Drug Administration (FDA).

Standards of identity for food

They are issued by the U.S. Department of Agriculture, the Food and Drug Administration or the Bureau of Alcohol, Tobacco, Firearms and Explosives.

Toxin and Toxin-Target Database

The various sources include the scientific literature, books, government documents, and numerous external databases (such as PubChem, UniProt, PubMed, DrugBank, Human Metabolome Database (HMDB), NIST Chemistry WebBook, KEGG, NCI Database Browser, PharmGKB, Food and Drug Administration, ChEBI, and ChemExper).