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
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
[email protected] or 715-369-6115.
The Wisconsin Tobacco Prevention and Control Program
Comprehensive funding is needed to continue decreasing the
Tobacco Use by the
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.
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
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."
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