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X FDA ACTS AGAINST 5 ELECTRONIC CIGARETTE O C T O B E R / N O V E M B E R / D E C E M B E R 2 0 1 0
X THE TOBACCO PREVENTION & CONTROL PROGRAM SAVES LIVES & MONEY. 2 X THE TOBACCO INDUSTRY TARGETS WISCONSIN KIDS . 3 X DOCTORS FIND DIFFERENT RESPONSES TO STOP-SMOKING TREATMENTS . 4 Northwood’s Tobacco-Free Coalition Serving Oneida, Florence, Forest, Lincoln, Price & Vilas Counties FDA Acts Against 5 Electronic
Cigarette Distributors
Agency cites unsubstantiated claims, poor manufacturing practices The U.S. Food and Drug Administration issued warning letters to five elec- tronic cigarette distributors for various violations of the Federal Food, Drug, and Cosmetic Act (FDCA) including unsubstantiated claims and poor Also, in a letter to the Electronic Cigarette Association, FDA said the agency intends to regulate electronic cigarette and related products in a manner consistent with its mission of protecting the public health. The letter outlines the regulatory pathway for marketing drug products in For a drug product to gain FDA approval, a company must demonstrate to the agency that the product is safe and effective for its intended use. The The companies receiving warning letters today are: E-CigaretteDirect LLC, company must also demonstrate that manufacturing methods are adequate to Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig preserve the strength, quality and purity of the product. Technology Inc. and Johnson’s Creek Enterprises LLC. “FDA invites electronic cigarette firms to work in cooperation with the Certain companies received warning letters for additional reasons. For agency toward the goal of assuring that electronic cigarettes sold in the example, E-Cig Technology markets drugs in unapproved liquid forms, United States are lawfully marketed,” the letter to the association read. such as tadalafil, an erectile dysfunction drug, and rimonabant, a weight loss FDA has determined that the electronic cigarette products addressed in the drug that has not been approved for use in the United States. These liquid warning letters to the distributors, and similar products, are subject to FDA pharmaceuticals are designed to refill cartridges used in e-cigarettes so that regulation as drugs. Under the FDCA, a company cannot claim that its drug can treat or mitigate a disease, such as nicotine addiction, unless the drug’s The FDA cited Johnson Creek Enterprises, which markets Smoke Juice, a safety and effectiveness have been proven. Yet all five companies claim liquid solution used to refill depleted cartridges in e-cigarettes, for several without FDA review of relevant evidence that the products help users quit significant deficiencies in its manufacturing processes, including failure to establish quality control and testing procedures required under the FDCA. JOIN THE COALITION
The Northwood’s Tobacco-Free Coalition is a coalition of individuals and organizations who are dedicated to improving the overall health, wellness, and quality of life of the citizens of our area. Any community member or organization in Oneida, Florence, Forest, Lincoln, Price, or Vilas County who is interested in tobacco prevention and control is invited to join the NWTFC.
For more information please go to www.nwtfc.org or contact Niki Kostrova at
nkostrova@co.oneida.wi.us or 715-369-6115.
The Wisconsin Tobacco Prevention and Control Program Comprehensive funding is needed to continue decreasing the Tobacco Use by the
Numbers:
Wisconsin smoke, com-pared with 10% nationally. Wisconsin invests only 10% of the amount recommended by the Centers for Disease Annual tax collections from smokers are the highest ever ($696 million from June Tobacco Is Still the #1
2009 to May 2010), but less than 1% of that amount is allocated to the Program to Cause of Preventable
provide services that treat and prevent tobacco addiction. The Program was cut in half in the last biennial budget. As a result: 42 community-based tobacco prevention programs were cut to 15. Cessation counseling services for smokers were reduced from secondhand smoke exposure, maternal smok- Without Adequate Funding, Tobacco Use Will Increase We All Pay
States that have slashed tobacco control funding, such as Florida and Massachusetts, have seen smoking rates increase. Wisconsin risks heading down the same path. $2.8 billion
Funding The Program Will Generate a Proven Return on Investment For each smoker who quits, Wisconsin saves $1,623 in Medicaid and other health- $9.53 per pack
to Wisconsin citizens in smoking-related healthcare In states with successful tobacco prevention and control programs, each dollar in- vested has saved at least $3.60 in tobacco-caused healthcare costs. If all tobacco products were taxed at the same per-unit rate (the current cigarette tax is $2.52 per pack), Wisconsin would gain revenue to fund tobacco prevention. Research Shows that a Fully Funded Tobacco Control Program is the Most Effective Way to Reduce the Burden of Tobacco on All Wisconsin Citizens. The Tobacco Industry Targets Wisconsin Kids Comprehensive funding is required to counteract dangerous new products Youth smokeless tobacco use is on the rise in Wisconsin. Big Tobacco is branching out: The tobacco industry has engineered a new line of products that don’t resemble traditional tobacco. Cigarette makers have bought the companies which Altria (Philip Morris) acquired U.S. Smokeless Smokeless tobacco advertising and promotion spending has The tobacco industry is responding aggressively to smoke-free laws such as Wisconsin’s by marketing smokeless tobacco as an alternative to quitting cigarettes. Flavored Products Appeal to Wisconsin Youth Candy flavorings and bright colors make smokeless products “Kid flavors” include chocolate, vanilla, mint, New products like Snus and Orbs look like candy. Tobacco company messages are still reaching young people. Smokeless and Other New Products Are Not a Safe Alternative to Smoking Despite the tobacco industry’s claims of reduced health risks, smokeless products are deadly. The health consequences of smokeless tobacco use include oral, throat and pancreatic cancer, tooth loss, gum disease and increased risk of heart disease, heart attack and stroke. Flavored Cigars and Smokeless Products Appeal to Children and Keep Smokers Addicted Medical: Doctors Find Different Responses to
Stop-Smoking Treatments
Addiction to nicotine is hardly a one-size-fits-all problem.
Scientists have a growing portfolio of evidence that tobacco smoke impacts the DNA of
different people in different ways, that individual smokers inhale differently and, conversely,
that tools used to try and break addiction don't work the same in everyone.
One study reported in July that humans have at least 323 genes whose expression levels are
affected by smoking behaviors.
Researchers from the Southwest Foundation for Biomedical Research in San Antonio studied
white blood cells taken from 1,240 people, including 297 current smokers, to identify changes in gene expression from exposure to cigarette smoke. "The scale at which exposure to cigarette smoke appears to influence the expression levels of our genes is sobering," said Jac Charlesworth, lead author of the study published in the British journal BMC Medical Genomics. Her team found significant changes in the smokers' expression of genes that influence immune response, cell death, cancer and metabolism of foreign particles compared to what was seen among nonsmokers. While the Texas study looked at the impact of tobacco smoke deep inside cells, another study, reported in August by scientists at the federal Centers for Disease Control and Prevention, found a new way to test the amount of chemicals that individual smokers are taking in each time they puff. Unlike data gathered from machines smoking cigarettes, the chemical analysis developed by CDC chemist Clifford Watson and colleagues offers an individual profile of "mouth-level exposure to the harmful substances in tobacco smoke,"the researcher said. The researchers removed filters from cigarette butts and measured the levels of a signature chemical, called solanesol, that occurs naturally in tobacco and is viewed as a good indicator of other chemical compounds in tobacco smoke — there are more than 7,000. Armed with such personalized data, the researchers say, doctors can better understand the health risks faced by individual smokers based on how they smoke. The information could also help guide health providers in designing treatments and therapy to help a person stop smoking. DNA variations may also help plot how people can best quit smoking. Researchers at the University of North Carolina reported last spring that they had found three genetic regions associated with the number of cigarettes smoked per day, another tied to smoking initiation and a third one tied to smoking cessation. While the gene variants reported in the journal Nature Genetics aren't yet ready to use in diagnosing addiction risk or plotting treatment, the researchers believe their findings move closer to customized smoking-cessation treatment. Surveys consistently show that about 70 percent of the nation's 46 million smokers want to quit, yet long-term quit rates even among those who use patches and other nicotine Scientists with the National Institute on Drug Abuse and Duke University have already been trying to match nicotine skin-patch doses to groups of genetic markers to predict a likelihood of quitting and what patch would work best with which variants. The Duke-NIDA study reported in July involved 479 smokers who smoked at least 10 cigarettes a day and wanted to quit. Each was tested for genetic patterns that other research had shown appear to influence how well an individual might respond to specific cessation treatments and assigned a "quit-success score" based on those markers. A short questionnaire was also used to assess the level of nicotine dependence for each smoker. The smokers were randomly assigned to wear two nicotine skin patches delivering a high (42 milligram) or low (21 milligram) dose for two weeks before their quit date and gradually When the patients were checked after six months, the researchers found that the genetic score helped predict successful abstinence. "People who had both high nicotine dependence and a low or unfavorable quit-success genetic score seemed to benefit markedly from the high-dose nicotine patch, while people who had less dependence on nicotine did better on the standard patch," said Jed Rose, director of Duke's Center for Nicotine and Smoking Cessation Research. Rose noted that the study needs to be repeated and also include other cessation therapies, but predicted, "Within three to five years, it's conceivable we'll have a practical test that could take the guesswork out of choosing a smoking-cessation therapy."

Source: http://www.tobwis.org/_Media/Content/1324328875Northwoods%20TFC%20Newsletter%20Oct2010.pdf

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