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31 Cards in this Set

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adjudication
The legal process of resolving a dispute. The formal giving or pronouncing of a judgment or decree in a court proceeding; also the judgment or decision given. The entry of a decree by a court in respect to the parties in a case. It implies a hearing by a court, after notice, of legal evidence on the factual issue(s) involved. The equivalent of a determination. It indicates that the claims of all the parties thereto have been considered and set at rest.
ACT-UP
AIDS Coalition to Unleash Power (ACT UP) is an international direct action advocacy group working to impact the lives of people with AIDS (PWAs) and the AIDS pandemic to bring about legislation, medical research and treatment and policies to ultimately bring an end to the disease by mitigating loss of health and lives.
Joseph Califano
from Brooklyn, New York. Following graduation from Harvard Law School in 1955, Mr. Califano then served as a lawyer in the Navy, which he subsequently left to join a Wall Street law firm. Califano later joined the Kennedy Administration and worked to reorganize the Pentagon with civilians. Califano described "an air of invincibility" in "imposing hands-on civilian control on the military." Following that he moved into the civil rights movement, determined to change American culture by changing peoples' beliefs and emotions. In 1976, Joseph Califano became Secretary of Health, Education and Welfare (HEW) under Jimmy Carter. President Carter was forced to fire him largely because Califano's "blunt, high-profile, self-promoting approach cost Carter too many political allies.” In 1992, Califano solicited millions of dollars in contributions to set up the Center on Addiction and Substance Abuse (CASA) > National Center on Addiction and Substance Abuse at Columbia University.
Carcinogens
Carcinogens are agents that can cause cancer. Examples of carcinogens include cancer causing chemicals, viruses, and environmental exposures.

Lung cancer can result from exposure to carcinogens in tobacco, as well as other environmental and occupational exposures. In industry, there are many potential exposures to carcinogens. Generally, workplace exposures are considered to be at higher levels than for public exposures. Material safety data sheets (MSDSs) should always contain an indication of carcinogenic potential.
Food, Drug and Cosmetic Act of 1938
the 1938 Food, Drug, and Cosmetic Act was a watershed in US food policy. the US, largely through the efforts of women’s groups, pioneered policies designed to protect the pocketbooks of consumers, and food standards were enacted to ensure the ‘value expected’ by consumers.[46] The 1938 Act eliminated the ‘distinctive name proviso’ and required instead that the label of a food ‘bear its common or usual name’. . The law provided for three kinds of food standards: 1) standards (definitions) of identity, 2) standards of quality, and 3) standards regulating the fill of container. Regulators had the discretionary authority to set standards ‘whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interests of consumers’
Newt Gringrich
1994 mid-term elections, Newt Gingrich became the first Republican Speaker of the House in 40 years. Most of the legislative items in his well-publicized "Contract with America" were passed by the House and many became law. His term as Speaker was marked by his opposition to many of Clinton's policies, which led to a budget showdown, government shutdowns, and acrimonious impeachment proceedings. However, Gingrich and Clinton also reached agreements on welfare reform, a capital gains tax cut, and a budget deal that led to four straight balanced budgets. Gingrich resigned from Congress in 1999. Ran for president.
David Kessler
Bush appointed him as FDA commissioner in December of 1990. Dr. Kessler was sworn in on the same day that the Nutrition Labeling and Education Act (NLEA) was signed. Early in his tenure, he took action to protect consumers from misleading uses of the term "fresh" in conjunction with processed or partially processed orange juice and tomato products, gaining himself the nickname "Elliot Knessler." Kessler himself later appeared on major news and entertainment shows to unveil the agency's new "Nutrition Facts" food labels. Designed with bold new graphics, they were intended to make food labels more useful to the consumer and soon became one of the most recognizable graphic formats in the world. He officially left his position Feburary 28, 1997. Was a leading force in giving FDA authority to regulate cigarettes as a drug, led to massive reforms/overhaul of tobacco industry.
Henry Waxman
is the U.S. Representative for California's 33rd congressional district, serving in Congress since 1975. He is a member of the Democratic Party. He is considered to be one of the most influential liberal members of Congress. His district includes much of the western part of the city of Los Angeles, as well as West Hollywood, Santa Monica and Beverly Hills. Relevant to the Kessler and FDA ongoing attempt to regulate the tobacco. Rep. Waxman has been the leading spokesperson on Capitol Hill for tobacco regulation since early in his congressional career. In the 1980s, he conducted dozens of hearings on the hazards of smoking and the tobacco industry’s marketing practices. These hearings contributed to a vast change in public opinion about smoking and led to the first reform of tobacco warning labels.
Jeff Nesbit
a national journalist, the communications director to the Vice President at the White House, and the director of public affairs for two prominent federal science agencies. Former FDA Commissioner David Kessler credited Jeff Nesbit with convincing the FDA to regulate the tobacco industry in the early 1990s (“A Question of Intent”).
rulemaking
"Rulemaking" is the term used when a government agency creates, modifies, or deletes rules in the Code of Federal Regulations (CFR). Rules are government agency statements (or parts of government agency statements) that either:

>Implement, explain or prescribe law or policy, or
>Describe an agency's organization, procedure, or practice requirements.
Jeffrey Wigand
the informant for Kessler, known as "Research" who was the scientist that worked for the Brown & Williamson Tobacco Company. He was the informant who spoke about genetically altering tobacco leaves in order to get higher levels of nicotine into cigarette production.
Donna Shalala
the US Department Secretary who replaced Lou Sullivan during the Clinton administration. She requested Kessler remain as the head of the FDA. Later on in Kessler's plight she provided survey material to aide in his battle with the industry and to help the President and his administration support the FDA
"Veritas"
the code name for the first informant from the tobacco industry Kessler spoke with during his investigation against the tobacco industry. This informant confirmed that Kessler was on the right track to inquire of the tobacco industry's intentional use of nicotine and the addiction it causes, the target among children and the impact of cigarettes on public health.
Surgeon General
the nations leading spokesperson on matters of public healt
Wall Street Journal
business journal that led or exposed the tobacco industry dealings kept those who wanted to be in the know informed
Louis Sullivan
predecessor of shalala, Secretary of Health and Human Services Louis Sullivan, 56, Became the #1 critic of tobacco industry after Koop departed.
Mike Synar
Kessler was instrumental , in helping craft a bill the Oklahoma Democrat has introduced. Synar's bill would:

Require manufacturers to disclose the 700 or so chemical additives--five of which have been declared hazardous substances--in tobacco products;

Reduce or prohibit the level of harmful additives (among them, according to a report by National Public Radio, are ammonia and ethyl furoid, which causes liver damage);

Require tobacco companies to warn of the addictive nature of nicotine;

Restrict tobacco advertising* and promotion, particularly ads aimed at minors;

Control the level of nicotine that cigarettes contain.
Phillip-Morris
preeminent agency/de facto leader of all tobacco companies that led fight against regulation and advertising since 1960's - 1st surgeon general report linking cancer to smoking cigarettes. admitted through reps that smoking causes cancers and they marketed children.
C. Everett Koop
Surgeon General - As U.S. Surgeon General from 1981 to 1989, he turned the office into an authoritative platform from which to educate the nation on major public health concerns including smoking, violence, and, most urgently, AIDS.
Marlboro Man
The Marlboro Man is a figure used in tobacco advertising campaign for Marlboro cigarettes. This campaign originated in the United States (first released in Texas) it was used from 1954 to 1999. The advertisements were originally conceived as a way to popularize filtered cigarettes, which at the time were considered feminine.
The Marlboro advertising campaign is said to be one of the most brilliant advertising campaigns of all time. The “famous” Marlboro Man is Darren Winfield and he led the campaign for 20 years.

Fun Facts: Marlboro Man campaign ran from 1954 to 1999. 5 out 6 of the “marlboro men” died of lung cancer. One of these men, Wayne McLaren, started an anti-smoking campaign; Phillip Morris denied McLaren ever appeared on a Marlboro ad. McLaren died in 1992 by the time Philip Morris was fighting against FDA over cigarettes being or not addictive.
Joe Camel
Joe Camel (officially Old Joe) was the advertising mascot for Camel cigarettes from late 1987 to July 12, 1997. The U.S. marketing team of R.J. Reynolds, looking for an idea to promote Camel's 75th anniversary, re-discovered Joe in the company's archives in the late 1980s.
Controversy: In 1991, the American Medical Association published a study showing that by age six nearly as many children could correctly respond that "Joe Camel" was associated with cigarettes as could respond that the Disney Channel logo was associated with Mickey Mouse, and alleged that the "Joe Camel" campaign was targeting children. At that time it was also estimated that 32.8% of all cigarettes sold illegally to underage buyers were Camels. Also in 1991, Janet Mangini, a San Francisco-based attorney, brought a suit against R. J. Reynolds, challenging the company for targeting minors with its "Joe Camel" advertising campaign.
Y-1 tobacco
Y1 is a strain of tobacco that was cross-bred by Brown & Williamson to obtain an unusually high nicotine content. It became controversial in the 1990s when the United States Food Drug Administration (FDA) under Commissioner David Kessler, conducted an investigation into the tobacco industry and used this to evidence that cigarette manufacturers were intentionally manipulating nicotine levels in cigarettes to keep their customers addicted.
nicotine
Is one of the thousands of chemicals in the tobacco plant (not to mention those added by cigarette manufacturers), which produces all the good feelings. In smaller doses (an average cigarette yields about 1 mg of absorbed nicotine), the substance acts as a stimulant in mammals, while high amounts can be fatal . Stimulant effect is likely a major contributing factor to the dependence-forming properties of tobacco smoking.

Interesting (at least to me): The nicotine content of popular American-brand cigarettes has slowly increased over the years, and one study found that there was an average increase of 1.78% per year between the years of 1998 and 2005. This was found for all major market categories of cigarettes.
R.J. Reynolds
An American businessman and founder of the R. J. Reynolds Tobacco Company. In 1913 Reynolds developed the packaged cigarette. Created Camel cigarettes. Undercut competitor costs, and within a year, sold 425 million packs of Camels. Eventually becoming the wealthiest person in North Carolina.
Pure Food & Drug Act of 1906
Signed by President Theodore Roosevelt. First federal law prohibiting the interstate transportation and sale of adulterated food. Was a result of the scandals that became widespread concerning unsanitary methods used by the food industry (ex: Upton Sinclair’s The Jungle)
Delaney Amendment
1958 amendment to the Food, Drugs, and Cosmetic Act of 1938. It said “the secretary of the FDA shall not approve for use in food any chemical additive found to induce cancer in man, or, after tests, found to induce cancer in animals”
Administrative oversight
Administrative agencies kept in check in two ways. Political oversight considers whether agencies are doing what the public wants. It is conducted by the elected branches through the appointment process, the budget, hearings, amendments to the enabling act, etc. Judicial oversight considers whether agencies are conforming to the requirements of the Constitution and their particular enabling act, regardless of public opinion. It is conducted by the court who hear challenges to the rules, enforcement, orders and the enabling act itself (--as per Sullivan in Life Raft)
US v. Rutherford
The question presented in this case is whether the Federal Food, Drug, and Cosmetic Act precludes terminally ill cancer patients from obtaining Laetrile, a drug not recognized as "safe and effective" within the meaning. The suit was originally instituted by a cancer patient, Juanita Stowe, and her husband, Jimmie Stowe. After Ms. Stowe's death, two other patients, Glen L. Rutherford and Phyllis S. Schneider, and Ms. Schneider's husband, filed an amended complaint on behalf of a class composed of all cancer patients and spouses responsible for the costs of treatment. Supreme Court upholds that the FDA has never made exception for drugs used by the terminally ill, therefore rejects a constitutional right to use unapproved drugs.

Plus all the presidents and when they were elected or succeeded to office.
Dr. Frances Kelsey
In November 1961, reports began to emerge in Germany and the United Kingdom that mothers who had taken thalidomide during pregnancy were now having babies with severe birth defects. Dr. Helen Taussig learned of the tragedy from one of her students and traveled to Europe to investigate. By testifying before the Senate, Tauusig was able to help Kelsey ban thalidomide in the United States for good. At least 4000 children in Europe were affected by the drug, but thanks to Kelsey's rigorous professionalism a similar tragedy was averted here in America
Thalidomide
medicinal drug that cures the skin disease that causes leprosy and blood cancer; a drug taken to fight myeloma. If taken causes severe and life threatening birth defects in fetus and infants, for example, abnormal limbs.David Kessler permitted this drug to be used in America during his reign in the FDA/in the 1990s.
Saccharin
artificial sweetner found to be a carcinogen