A U.S. scientific panel this month will weigh the controversial role of popular menthol flavoring in cigarettes in the first public meeting on tobacco products since a new law granted regulators power over the industry last year. Over two days, the Food and Drug Administration’s panel of outside experts will look at the health impact of the mint-like additive on smoker’s use as well as addiction and health, with another meeting set later this year, the FDA said on Monday. ... read more >>
Posts Tagged ‘FDA’
FDA panel to target menthol cigarettes
Tuesday, March 2nd, 2010
FDA concerned dissolvable tobacco appeals to kids
Friday, February 5th, 2010
The Food and Drug Administration is saying in letters to two tobacco companies that flavored, dissolvable tobacco products – that the agency compares with candy and says contain a lot of nicotine – could be particularly appealing to kids and young adults. The FDA’s Center for Tobacco Products wrote to R.J. Reynolds Tobacco Co., maker of Camel cigarettes, and the smaller Star Scientific Inc. on Monday voicing concern over smokeless products that are consumed like breath mints but made from finely milled tobacco. ... read more >>
The Food and Drug Administration is saying in letters to two tobacco companies that flavored, dissolvable tobacco products – that the agency compares with candy and says contain a lot of nicotine – could be particularly appealing to kids and young adults. The FDA’s Center for Tobacco Products wrote to R.J. Reynolds Tobacco Co., maker of Camel cigarettes, and the smaller Star Scientific Inc. on Monday voicing concern over smokeless products that are consumed like breath mints but made from finely milled tobacco. ... read more >>
Freeze? What freeze? FDA in line for another budget boost
Wednesday, February 3rd, 2010
The Food and Drug Administration is a screaming exception to the Obama administration’s freeze on discretionary spending in the 2011 budget. Overall, the FDA budget could grow by as much as 23% to just over $4 billion from the current $3.3 billion. But getting all of what the agency wants will require Congress to authorize more than a quarter-billion dollars of new fees on food facilities and generic drug makers. ... read more >>
The Food and Drug Administration is a screaming exception to the Obama administration’s freeze on discretionary spending in the 2011 budget. Overall, the FDA budget could grow by as much as 23% to just over $4 billion from the current $3.3 billion. But getting all of what the agency wants will require Congress to authorize more than a quarter-billion dollars of new fees on food facilities and generic drug makers. ... read more >>
Bayer starts clinical Phase I study with personalized vaccine from tobacco plants
Friday, January 29th, 2010
The transfer into clinical development of a patient-specific vaccine represents a milestone for Bayer Innovation GmbH. Following approval of the Phase I study by the FDA (Food & Drug Administration) in the United States, the vaccine is now being tested in human subjects. This is the first time that proteins obtained from tobacco plants using magnICON® technology undergo clinical testing. The patient-specific vaccines produced in the pilot plant operated by the Bayer-subsidiary Icon Genetics in Halle, Germany, are intended for the treatment of non-Hodgkin’s lymphoma (NHL), a type of cancer affecting lymphocytes. The objective of the therapy is to activate the patient’s immune system, enabling the malignant cells to be targeted and destroyed by the body’s own defense system. ... read more >>
The transfer into clinical development of a patient-specific vaccine represents a milestone for Bayer Innovation GmbH. Following approval of the Phase I study by the FDA (Food & Drug Administration) in the United States, the vaccine is now being tested in human subjects. This is the first time that proteins obtained from tobacco plants using magnICON® technology undergo clinical testing. The patient-specific vaccines produced in the pilot plant operated by the Bayer-subsidiary Icon Genetics in Halle, Germany, are intended for the treatment of non-Hodgkin’s lymphoma (NHL), a type of cancer affecting lymphocytes. The objective of the therapy is to activate the patient’s immune system, enabling the malignant cells to be targeted and destroyed by the body’s own defense system. ... read more >>
FDA to investigate tobacco ingredients
Thursday, January 28th, 2010
After starting smoking in college as a way to stay awake to study, Tom Tenner said he realized he wasn’t receiving anything from smoking other than a chance at life-threatening disease. “If you’ve got really great genes that would normally have you living into your 90s and you start smoking at a young age, you will more than likely pass in your 60s or 70s,” said Tenner, associate dean for Faculty Affairs and Development at the Texas Tech Health Sciences Center and past president of the American Heart Association. “Now think if you don’t have those great genes to start with, you’re more likely to pass in your 40s or 50s.” ... read more >>
After starting smoking in college as a way to stay awake to study, Tom Tenner said he realized he wasn’t receiving anything from smoking other than a chance at life-threatening disease. “If you’ve got really great genes that would normally have you living into your 90s and you start smoking at a young age, you will more than likely pass in your 60s or 70s,” said Tenner, associate dean for Faculty Affairs and Development at the Texas Tech Health Sciences Center and past president of the American Heart Association. “Now think if you don’t have those great genes to start with, you’re more likely to pass in your 40s or 50s.” ... read more >>
Court backs some tobacco ad bans, nixes others
Tuesday, January 26th, 2010
A recent federal court decision moved public health advocates several big strides forward and a couple of steps back in their effort to defeat a free speech challenge to new Food and Drug Administration restrictions on tobacco advertising. ... read more >>
A recent federal court decision moved public health advocates several big strides forward and a couple of steps back in their effort to defeat a free speech challenge to new Food and Drug Administration restrictions on tobacco advertising. ... read more >>
Scientists want more safety studies on e-cigarettes
Wednesday, January 20th, 2010
Greek researchers called on Wednesday for more safety studies into electronic cigarettes, saying scientific knowledge of them was “very limited”. Electronic cigarettes, or e-cigarettes, were first made in China and are sold mostly on the Internet. They are battery-powered devices which emit a “puff” or fine mist of nicotine into the lungs and are intended to replace normal cigarettes and help smokers quit. ... read more >>
Greek researchers called on Wednesday for more safety studies into electronic cigarettes, saying scientific knowledge of them was “very limited”. Electronic cigarettes, or e-cigarettes, were first made in China and are sold mostly on the Internet. They are battery-powered devices which emit a “puff” or fine mist of nicotine into the lungs and are intended to replace normal cigarettes and help smokers quit. ... read more >>
The e-cigarette lights up a debate
Monday, January 18th, 2010
Sharon Bosworth is running out of ways to break the grip of the cigarette. Suffering from emphysema, the Overland Park woman, 51, has tried gum, the patch and even classes on how to quit. Now she is turning to a cigarette for the 21st century, one that relies on electricity, batteries and liquid nicotine instead of matches, fire and tobacco. ... read more >>
Sharon Bosworth is running out of ways to break the grip of the cigarette. Suffering from emphysema, the Overland Park woman, 51, has tried gum, the patch and even classes on how to quit. Now she is turning to a cigarette for the 21st century, one that relies on electricity, batteries and liquid nicotine instead of matches, fire and tobacco. ... read more >>
The New FDA Guidance on the Listing of Ingredients in Tobacco Products
Wednesday, December 16th, 2009
The Federal Food and Drug Administration (“FDA”) recently posted a new Guidance for the tobacco industry, entitled Listing of Ingredients in Tobacco Products, (the “Guidance”) concerning the mandatory listing of ingredients with a rapidly approaching deadline of December 22, 2009. Among several specific and noteworthy interpretations provided in the Guidance, the FDA has indicated it does not intend to enforce the December 22, 2009 deadline. ... read more >>
The Federal Food and Drug Administration (“FDA”) recently posted a new Guidance for the tobacco industry, entitled Listing of Ingredients in Tobacco Products, (the “Guidance”) concerning the mandatory listing of ingredients with a rapidly approaching deadline of December 22, 2009. Among several specific and noteworthy interpretations provided in the Guidance, the FDA has indicated it does not intend to enforce the December 22, 2009 deadline. ... read more >>
Wellstone in Conference Call With FDA
Tuesday, November 3rd, 2009
CHAPEL HILL, N.C.–(BUSINESS WIRE)–Wellstone Filters Sciences, Inc. (OTC Bulletin Board: WFSN), the leading modified risk cigarette filter company, is pleased to announce that it participated in the FDA’s conference call regarding the guidance document entitled “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” ... read more >>
CHAPEL HILL, N.C.–(BUSINESS WIRE)–Wellstone Filters Sciences, Inc. (OTC Bulletin Board: WFSN), the leading modified risk cigarette filter company, is pleased to announce that it participated in the FDA’s conference call regarding the guidance document entitled “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” ... read more >>
FDA Moves Forward on Implementation of Tobacco Law
Wednesday, August 26th, 2009
The U.S. Food and Drug Administration today announced an action regarding the implementation of the Family Smoking Prevention and Tobacco Control Act. The Agency has officially established the Tobacco Products Scientific Advisory Committee (TPSAC). ... read more >>
The U.S. Food and Drug Administration today announced an action regarding the implementation of the Family Smoking Prevention and Tobacco Control Act. The Agency has officially established the Tobacco Products Scientific Advisory Committee (TPSAC). ... read more >>
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