Food and Drug Administration – Page 3

New Legislation may Weaken FDA’s Regulation of Cigarettes

Source: The Los Angeles Times The U.S. Food and Drug Administration barely had time to start regulating cigarettes before legislation was introduced to weaken its authority. The Family Smoking Prevention and Tobacco Control Act was passed in 2009 with sweeping majorities in both houses; its primary goal was to reduce the terrible toll that smoking takes on Americans' health, especially by discouraging young people from taking up the habit. The law gave the FDA the authority to regulate the advertising and packaging of cigarettes, along with ingredients such as nicotine and flavorings that affect how easily the public is drawn into smoking and how addictive the habit is once started. As required in the law, for example, the FDA banned candy flavorings in cigarettes, which make the product more appealing to underage smokers and young adults. But now that the agency is taking meaningful steps against smoking, Rep. Denny Rehberg (R-Montana) has added an amendment to the agriculture appropriations bill that would restrict the FDA's authority over cigarettes and a host of other matters. Currently, the FDA is considering whether to ban one of the most popular and profitable ingredients — menthol — but Rehberg's amendment would keep it from taking that action. No longer would the FDA be able to consider a substance's tendency to attract smokers or make cigarettes more addictive. Rather, the FDA could only ban or limit ingredients that are found to make the cigarette physically more harmful than existing products. Menthol has not been found [...]

Oral Cancer Foundation News Team - A2011-06-09T09:58:11-07:00June, 2011|Oral Cancer News|

Philip Morris Int’l purchases license to nicotine system

Source: Associated Press Cigarette maker Philip Morris International Inc. has purchased the rights to a technology that lets users inhale nicotine without smoking. The world's largest nongovernmental cigarette seller told The Associated Press on Thursday it has bought the patent for an aerosol nicotine-delivery system developed by Jed Rose, director of the Center for Nicotine and Smoking Cessation Research at Duke University in Durham, N.C. The school does not have a role in Rose's agreement with the company and won't receive any money. Terms were not disclosed. "By avoiding the burning process altogether, finding a way of giving smokers nicotine to inhale but without those toxic substances that we can reduce the death and disease associated with smoking," said Rose, who led the initial studies in the early 1980s that helped pave the way for commercial nicotine patches as a smoking cessation treatment. "Hopefully it's a wave of the future that inhaling combusted, burning tobacco will someday be a thing of the past." Rose said the next step is for Philip Morris International, with offices in New York and Lausanne, Switzerland, to develop a commercial product using the technology. The system differs from current medicinal nicotine inhalers available on the market as stop-smoking aids because it delivers nicotine more rapidly to mimic the nicotine "hit" a cigarette provides smokers. "The other methods of delivering nicotine fall short of providing smokers with the satisfaction that they crave," Rose said. The move is an "important step in our efforts to develop products [...]

Oral Cancer Foundation News Team - A2011-05-27T10:56:57-07:00May, 2011|Oral Cancer News|

FDA panel finds ban on menthol cigarettes would ‘benefit the public health’

Source: www.washingtonpost.com Author: Lyndsey Layton An advisory panel to the Food and Drug Administration that has been studying whether the government ought to ban menthol cigarettes said Friday that the “removal of menthol cigarettes from the marketplace would benefit the public health.” The panel, made up of scientists, doctors and public health experts, stopped short of recommending a ban on menthol cigarettes, which make up about 30 percent of the $80 billion U.S. cigarette market. The committee, which spent a year analyzing menthol cigarettes before releasing its draft recommendations, said that compared to standard cigarettes, the mint-flavored products do not pose greater individual risk to smokers in terms of lung cancer, stroke and other tobacco-related diseases. But menthol cigarettes are especially enticing to teenagers and to blacks and are more likely to turn them into lifetime smokers, the panel found. Smokers of menthol cigarettes also find it harder to quit, the panel said. Lawrence R. Deyton, director of the FDA’s Center for Tobacco Products, said the agency will review the panel’s recommendations. The FDA is not required to follow the advice of its advisory panels but often does. “Now it’s up to us to do our job,” Deyton told the panel. The menthol question will be the first real test of how aggressively the FDA intends to regulate tobacco. Congress passed landmark legislation in 2009 that put tobacco under the authority of the FDA for the first time. The law prohibits the agency from outlawing tobacco or nicotine but gives [...]

Oral Cancer Foundation News Team - A2011-03-19T09:29:53-07:00March, 2011|Oral Cancer News|

Popularity surges for e-cigarettes, but health questions unanswered

Source: ArgusLeader.com Misti Stewart of Gregor's Eastside Liquor demonstrates an electronic cigarette. They have gained popularity since the smoking ban. / Elisha Page / Argus Leader Jeff Mann has found a way to get his nicotine fix with no ash, no flame, no odor and no bad breath. And he can do it legally inside businesses that are smoke free. Mann, 40, smokes an electronic cigarette. It's a battery-powered device that looks like a cigarette and emits cigarette-like smoke, but delivers nicotine in vapor form. "You can get a nicotine level that you're used to getting from a regular cigarette," Mann said. E-cigarettes have been available in the United States since 2006 and have grown in popularity in Sioux Falls since the smoking ban went into effect Nov. 10. They're sold in bars, casinos and various retail shops. At least one local distributor has seen a 50 percent increase in sales. But the federal Food and Drug Administration has not approved e-cigarettes. That raises red flags for some health professionals and has them questioning what risks might be associated with e-cigarettes. Smoker says device helped him cut back The FDA lost a court case last year after trying to treat e-cigarettes as drug-delivery devices instead of tobacco products because e-cigarettes heat nicotine extracted from tobacco. But Mann, who owns Vishnu Bunny Tattoo and Piercing, views e-cigarettes as a healthier alternative to the traditional cigarettes he has smoked for 25 years. He said it has helped him cut down on smoking. [...]

Oral Cancer Foundation News Team - A2011-02-22T11:36:28-07:00February, 2011|Oral Cancer News|

Does chocolate hold the key to cure HPV?

Source: Yahoo News Indulgent chocolate treats may be the best-known and most widely appreciated product of the cacao tree, but new scientific research from New York Based Cacao Biotechnologies is uncovering potential new applications for the antioxidant-rich beans which could spur an innovative approach to treating human papillomavirus (HPV), a precursor to cervical cancer. The human papillomavirus is the most common sexually transmitted infection (STI) in the United States, with an estimated 24 million active cases and 5.5 million new cases each year, according to the National Cancer Institute. HPV is the leading cause of cervical cancer in woman with more than 12,000 cases reported in the U.S. each year. HPV vaccines approved by the Food and Drug Administration are available, but they are not a cure and they can’t effectively prevent all strains of HPV infection in those who are sexually active. Existing vaccines are only proven effective against a small number of high-risk, cancer-causing HPV strains and are not free of serious side effects including convulsions and paralysis. While condoms can reduce the risk of HPV infection, the virus can still be transmitted simply through skin contact of areas not covered by the condom. Vaccination will not cure someone who is already infected with the virus, so even with massive public health education campaigns, HPV will not soon be eradicated because it is so widely spread in the adult population. According to Penny Hitchcock, Chief of the Sexually Transmitted Diseases Branch of the U.S. government’s National Division of [...]

Oral Cancer Foundation News Team - A2011-02-04T12:16:39-07:00February, 2011|Oral Cancer News|

Ban flavored tobacco products

Source: www.acscan.org Author: staff On 1/5/11, the Assembly introduced legislation banning the sale of flavored tobacco products. The American Cancer Society continues to be a strong advocate of this effort. Below is our memo of support: Memorandum In Support A. 288 An Act to amend the public health law, in relation to prohibiting the sale of flavored tobacco products. This measure prohibits the sale in New York of tobacco products, other than cigarettes, containing natural or artificial additives that impart to a tobacco product or its smoke flavors attractive to youth including, but not limited to, fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, herb or spice flavoring. Menthol, mint and wintergreen flavors are excepted. In no event shall a tobacco product be construed as flavored based solely on the use of additives or flavorings in its manufacture, or their presence on an ingredient list. In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act granting the federal Food and Drug Administration authority to regulate tobacco products and banning the use of flavors other than menthol in cigarettes. However, other tobacco products, including "little cigars" (cigarettes wrapped in paper containing tobacco), cigars, snuff and other smokeless tobacco products were not included in the prohibition. This bill corrects that oversight. An important function of the flavorings affected by this legislation is to mask from tobacco product users, particularly new users, the harsh, toxic properties of tobacco smoke and spit tobacco. Tobacco industry internal documents uncovered during the course [...]

Oral Cancer Foundation News Team - A2011-01-12T16:02:56-07:00January, 2011|Oral Cancer News|

Tobacco manufacturers must report ingredients to FDA

Source: www2.journalnow.com Author: Richard Craver The Food and Drug Administration is giving tobacco manufacturers less than three months to provide proof that any product introduced since February 2007 is "substantially equivalent" to products already in the marketplace. If a manufacturer does not file a report by March 22, or cannot substantiate its evidence, the FDA said Wednesday that it could remove the product from store shelves. The announcement updated the guidance provided to manufacturers in June 2009 as part of enacting the Family Smoking Prevention and Tobacco Control Act. Manufacturers of any product introduced after March 22 must submit an application and obtain a marketing order from the FDA before placing the product on the market. The emphasis of the new rules puts R.J. Reynolds Tobacco Co. in the bull's-eye because it has been the most prolific developer of tobacco products in recent years, including Camel Snus and the Camel orbs, sticks and filmlike strips for the tongue. "No known existing tobacco product is safe, and a market order issued by the FDA for these products should never be interpreted as such," said Dr. Lawrence Deyton, the director of the FDA's Center for Tobacco Products. "These products will not be safer, but we are required by this law to not allow even more dangerous products to cause further harm to those Americans who use tobacco products." The FDA defined "substantially equivalent" as "being the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single-predicate [...]

Oral Cancer Foundation News Team - A2011-01-06T19:09:22-07:00January, 2011|Oral Cancer News|

New snuff low in carcinogens, Virginia company says

Source: www2.journalnow.com Author: Richard Craver A small tobacco manufacturer in Richmond, Va., said Tuesday that it has developed a moist-snuff product that has the lowest levels of carcinogens — in this case nitrosamines — in the marketplace. That includes "99 percent lower than the levels found in conventional American moist snuffs, such as Copenhagen or Skoal, and 90 percent less than the level found in current snus products," the company said. Star Scientific Inc. plans to apply soon to the Food and Drug Administration for permission to market the product, part of its Stonewall brand, as "modified risk" under the Family Smoking Prevention and Tobacco Control Act of 2009. That act gave the FDA the regulatory control over new tobacco products. Star applied last year to market its Ariva and Stonewell lozenges as modified risk. "Our company's belief and hope is that the FDA will give a robust look at the science of our application and other reduced-risk applications," said Sara Machir, the vice president of communications and investor relations for Star. The request is likely to stoke further debate between two sets of anti-smoking groups. One set says smokeless tobacco serves as gateway products for teenagers to cigarettes and discourages users from quitting. The other set says the products are a way to reduce the risk of tobacco use compared with cigarettes. Scott Ballin, the past chairman of the Coalition on Smoking or Health, said the debate "is more about competition, market share and profits than it is about [...]

Oral Cancer Foundation News Team - A2011-01-07T11:41:27-07:00January, 2011|Oral Cancer News|

RJ Reynolds’ ads urge tobacco pouches for smokers

Source: washingtonexaminer.com Author: Emery P. Dalesio R.J. Reynolds Tobacco Co. is targeting people who resolve to quit smoking in the new year with advertisements suggesting they switch to its smokeless tobacco pouches, a move critics say is an attempt to keep people from quitting nicotine. The ads mark the company's first campaign aimed at getting smokers to switch to the pouches known as snus, which Reynolds introduced in early 2009, spokesman David Howard said Wednesday. The carefully worded ads suggest, but don't say directly, that the pouches are a way to help kick the smoking habit. Under federal law, companies cannot claim that tobacco products work as smoking cessation products. But tobacco companies would love for smokers to think of them that way as cigarette sales fall because of higher taxes, smoking bans and falling social acceptability. The No. 2 U.S. cigarette maker is advertising in major magazines this month its suggestion for a "2011 Smoke-Free Resolution" in some ads that show the tobacco-filled white pouches dropping from the sky like confetti. The ads promote the company's Camel snus — small pouches filled with tobacco that users stick between the cheek and gum. "If you've decided to quit tobacco use, we support you. But if you're looking for smoke-free, spit-free, drama-free tobacco pleasure, Camel Snus is your answer. Logon to the Pleasure Switch Challenge and see how simple switching can be. Camel Snus — it might just change the way you enjoy tobacco," one ad says. "At this time, there [...]

Oral Cancer Foundation News Team - A2011-01-01T18:06:48-07:00January, 2011|Oral Cancer News|

Reynolds targets smokers trying to quit with new snus campaign

Source: www.csnews.com Author: staff R.J. Reynolds Tobacco Co. wants cigarette smokers to consider Snus if they are trying to quit. According to the Winston-Salem Journal, the giant tobacco company has launched a national campaign marketing Camel Snus as a potential New Year’s Resolution solution for smokers. It’s the company’s first campaign aimed specifically at encouraging smokers to switch to Camel Snus, according to David Howard, a Reynolds spokesman. "A lot of adults make a decision to quit smoking this time of the year," said Howard in the report. "For those making that attempt, but still wanting the pleasure of tobacco, we’re saying ‘Here’s an option." Reynolds has run ads in large-circulation magazines such as Entertainment Weekly, People, Sports Illustrated, Time and US Weekly, as well as free and alternative publications, according to the report. In the "2011 smoke-free resolution" ad, Reynolds said it supports smokers who have decided to quit using tobacco. "But if you’re looking for smoke-free, spit-free, drama-free tobacco pleasure, Camel Snus is your answer," the ad’s text reads. The ads also contain a large warning that "smokeless tobacco is addictive." Howard said that the "drama-free" reference is aimed at adults who want to use tobacco products in restaurants, bars and other social outlets where smoking is discouraged or banned. Reynolds’ print ads are part of a "take the pleasure switch challenge" campaign tied to an age-restricted Camel Snus Web site. As might have been expected, some anti-smoking groups are upset by the ads. "The ads are trying [...]

Oral Cancer Foundation News Team - A2010-12-30T15:54:40-07:00December, 2010|Oral Cancer News|