FDA Clears First Tobacco Product for Marketing

For the first time since it was given the power to regulate tobacco, the US Food and Drug Administration (FDA) has authorized marketing of a new product. The agency said that eight new smokeless snus products, to be sold in the United States under the "General" brand name by Stockholm-based Swedish Match AB, are now authorized under the premarket tobacco application pathway, which was established by the 2009 Family Smoking Prevention and Tobacco Control Act. Snus cannot be marketed as "FDA-approved," however. "Today's action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed, as long as the public health can be protected," said Mitch Zeller, director of the FDA's Center for Tobacco Products, in a statement. This is the first time any tobacco maker has completed the rigorous premarket tobacco application review process at the agency; others have had products approved by proving they are substantially equivalent to what is already on the market. The agency said that Swedish Match provided evidence that "these products would likely provide less toxic options if current adult smokeless tobacco users used them exclusively." The agency also agreed with the company that snus' availability would not result in substantial new use, delay quit attempts, or attract ex-smokers. Swedish Match had been seeking separately to remove warnings that snus is harmful, but the agency has not yet ruled on that request. In that separate application, Swedish Match was seeking to have the 10 types of snus it [...]

2015-11-13T15:25:42-07:00November, 2015|Oral Cancer News|

The 795 Thousand and Ending a Century of Tobacco

Source: Oxford Journals Tonight, a grandfather will read his grandson a soothing bedtime story. Yesterday, a mother saw her son perform a brilliant violin solo. Tomorrow, a grandfather will see his granddaughter complete the first unassisted triple play in their community's t-ball league history. What do these vignettes have in common? They represent just three of the 795 851 people––the 795 thousand––whose premature deaths from lung cancer were averted in the United States through aggressive tobacco control policies and interventions between 1975 and 2000, as determined by a series of consortium-based sophisticated modeling techniques and reported by Moolgavkar et al. (1) in this issue of the Journal. Sometimes, we become inured to the sheer number of deaths caused by tobacco—for example, a predicted 1 billion tobacco-caused deaths this century, 100 million people killed by tobacco in the 20th century, 6 million deaths per year globally, 443 000 deaths per year in the United States, etc. But, despite these enormous, and even numbing, numbers, we need to remember that every one of these 1 billion, 100 million, 6 million, or 443 000, was a father, mother, brother, sister, son, or daughter who, if tobacco had not intervened, would have enjoyed, and shared, a longer, healthier, and more fulfilling life. How did this happen? How did we allow tobacco, over the past 100 years, to kill and cause disease with such abandon? And, more important, how have we begun to turn the tide against the tobacco tsunami and how can we continue to learn from [...]

2012-04-04T08:27:45-07:00April, 2012|Oral Cancer News|

Judge Rules Graphic Cigarette Warning Labels Unconstitutional

 Source: Time Magazine- Healtland The government’s effort to put graphic warning labels about the dangers of smoking on cigarette packs hit another legal snag on Wednesday. A Washington judge declared unconstitutional a Food and Drug Administration (FDA) mandate that would force cigarette makers to use the labels, which include images of a corpse of a smoker, smoking-damaged teeth and gums and diseased lungs, saying that it violated cigarette makers’ freedom of speech under the First Amendment. U.S. District Judge Richard Leon wrote in his ruling that the images “were neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks; rather, they were crafted to evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking.” SPECIAL: FDA Unveils Final Cigarette Warning Labels That’s been the argument of cigarette makers, who say that the images go beyond merely informing the public to forcing the manufacturers to advertise the government’s anti-smoking agenda, with the purpose of convincing smokers to give up the habit. Leon’s ruling fell in line with his previous decision in the case in November, when he issued a temporary injunction blocking the new labeling effort. That decision has already been appealed by the government. The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA regulatory authority over tobacco products for the first time. Under that law, the FDA required cigarette makers to cover the top half of the front and back of cigarette [...]

2012-03-01T14:10:43-07:00March, 2012|Oral Cancer News|

FDA to weigh safety of tobacco lozenges, strips

Source: USA Today They may look and smell a lot like candy, but dissolvable, smokeless tobacco products aren't for kids. The safety and risks of "dissolvables" are the subject of a three-day U.S. Food and Drug Administration meeting this week. This is a concept of the Camel Orbs a smokeless tobacco product by RJ Reynolds company. The company is test marketing Camel Orbs, Camel Strips and Camel Sticks in two cities. "Dissolvables" are flavored mints, strips and sticks of smokeless tobacco. These products are not stop-smoking aids. Instead, they are designed to allow people to satisfy their cravings for nicotine in places where smoking is banned. R.J. Reynolds Tobacco Co. is test marketing Camel Orbs, Camel Strips and Camel Sticks in two cities, and Star Scientific Inc., is marketing two other dissolvable tobacco products, Ariva and Stonewall. Many public health advocates are concerned about the risks these products pose to children and teens, namely possible addiction and nicotine poisoning. "If you wanted to design a product that would appeal to youth and addict younger adolescents and adults to nicotine, this would be it," said Dr. Jonathan Winickoff, a pediatrician at Massachusetts General Hospital in Boston. "These products are designed to look like a candy and addict the user permanently." Teens can pop these products without any of the telltale signs of smoking cigarettes or the mess associated with snus, which are teabag-like pouches placed between the upper lip and gun. Before long, he said, they're addicted. Another worry is accidental [...]

2012-01-19T10:17:01-07:00January, 2012|Oral Cancer News|

Graphic images influence intentions to quit smoking; study examines the effect of images to appear on cigarette packages

Source: www.newswise.com Author: staff Marketing researchers at the University of Arkansas, Villanova University and Marquette University surveyed more than 500 U.S. and Canadian smokers and found that the highly graphic images of the negative consequences of smoking have the greatest impact on smokers’ intentions to quit. The most graphic images, such as those showing severe mouth diseases, including disfigured, blackened and cancerous tissue, evoked fear about the consequences of smoking and thus influenced consumer intentions to quit. “These results suggest that there appears to be little downside on intentions to quit from using extremely graphic pictorial depictions of the negative health outcomes due to smoking,” said Scot Burton, co-author of the study and marketing professor in the Sam M. Walton College of Business. “Our research shows that strong, negative graphic imagery – and fear evoked from such imagery – influences smokers’ intentions to quit. We also found this to be the case even though recall of the written messages on package labels was reduced by the more graphic images. In other words, smokers were influenced primarily by the images and not by the written message.” Burton, Jeremy Kees and John Kozup, both marketing professors at the Villanova University, and Craig Andrews, marketing professor at Marquette University, developed the study to help officials at the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services better understand what types of pictorial warnings are most effective and why they are effective. These agencies are responsible for implementing the [...]

2010-11-14T08:43:19-07:00November, 2010|Oral Cancer News|

Flavored cigarette ban takes effect 9/22

Source: MSN.com Author: Karen Pallarito New federal law may help deter young smokers, health advocates say TUESDAY, Sept. 22 (HealthDay News) -- Young people who enjoy a hint of vanilla, berry or chocolate when they light up are about to have their favorite smokes snuffed out. A new federal law banning fruit- and candy-flavored cigarettes takes effect Sept. 22. The prohibition is part of the Family Smoking Prevention and Tobacco Control Act, legislation that grants the U.S. Food and Drug Administration the authority to regulate tobacco products. President Barack Obama signed the measure into law June 22. Studies show that flavored cigarettes, which have been around for about a decade, disproportionately appeal to America's youth. Thus, banning the manufacture and sale of kid-friendly flavored cigarettes is a critical step toward deterring young smokers, health advocates said. "Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers," FDA Commissioner Dr. Margaret A. Hamburg said in a news release. "The FDA will utilize regulatory authority to reduce the burden of illness and death caused by tobacco products to enhance our nation's public health." Gregg Haifley, associate director of federal relations for the American Cancer Society Cancer Action Network in Washington, D.C., said, "Banning candy and fruit flavorings in cigarettes can have a significant effect on the reduction of initiation of smoking among youth, as well as reducing the number of youth who go on to regular, [...]

2009-09-22T16:48:58-07:00September, 2009|Oral Cancer News|
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