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Perspective: Lessons Learned from the First Review of Modified Risk Tobacco Product (MRTP) Applications

we denied Swedish Match ...the scientific evidence was not sufficient to demonstrate that consumers would understand the modified risk information proposed by the applicant in the context of total health, particularly when this information is provided in
FDA - Food and Drug Administration
added Dec 16, 2016 21:29
4 Views

FDA: Snus styles must maintain consumer warning

A group of eight General Snus styles will not be allowed to remove a consumer warning that the products can cause gum disease and tooth loss...Camel Snus, made by R.J. Reynolds Tobacco Co., dominate the American market.
Winston-Salem (NC) Journal
added Dec 16, 2016 21:25
4 Views

FDA drops black box warning on Pfizer's anti-smoking drug

allowed Pfizer Inc to remove a serious warning from the label of its smoking cessation treatment, Chantix, giving a new lease of life to the controversial drug that was approved a decade ago. The U.S. Food and Drug Administration slapped a "black box" wa
Reuters
added Dec 16, 2016 19:39
3 Views

FDA Approves Removal Of Boxed Warning Regarding Serious Neuropsychiatric Events From CHANTIX® (varenicline) Labeling

Labeling Revisions Also Include Updates to Corresponding Warning and Addition of Clinical Data on Superior Efficacy of CHANTIX Compared to Bupropion or Nicotine Patch1
Business Wire
added Dec 16, 2016 19:37
3 Views

[Asia-pacific, Korea - South] Graphic Images to be Added on Tobacco Packets to Lower Korea’s Smoking Rate

Starting on December 23, appalling graphic images will be added to cigarette packets in a dire attempt to cut down the country's smoking rate. These graphic photos will give smokers a closer and clearer look at the possible effects of longtime smoking. Th
Korea Portal
added Dec 16, 2016 18:41
21 Views

Teens May Not Heed Health Warnings on Cigars

"Many still believe that risks of cigars can be mitigated by not inhaling or inhaling less," he said in a university news release. "But we know that cigar smoking can cause serious harm, including cancer and heart disease." The researchers surveyed mor
HealthDay [HealthScout]
added Dec 16, 2016 18:22
8 Views

[Australia] Sneaky tobacco companies use mystery shoppers to exploit ciggie loophole

Tobacco companies are offering gift cards, flights and hotel stays to retailers to try and encourage them to push their brand onto customers.... Mystery shoppers hired by Imperial Tobacco are sent to retailers with a very specific script. "I normally sm
New Zealand Herald (nz)
added Dec 16, 2016 16:33
10 Views

FDA opens door to reduced risk claim for Swedish Match snus tobacco

The agency said the company could not remove a warning that the products may cause gum disease and tooth loss. But it deferred a decision on whether to allow the company to claim the products cause less harm than cigarettes. It also deferred a decision
Reuters
added Dec 14, 2016 20:51
6 Views

FDA Issues a Response to Application From Swedish Match

Swedish Match was informed earlier today by the FDA that General Snus will not, for the time being, be designated as a Modified Risk Tobacco Product - MRTP. The FDA did, however, outline the process forward and encouraged Swedish Match to continue its ef
PR Newswire
added Dec 14, 2016 20:25
6 Views

FDA takes action on applications seeking to market modified risk tobacco products

Based on the scientific evidence provided in the applications, as well as other available data, the agency determined that the request to remove the warning related to gum disease and tooth loss should be denied because these products can cause gum disea
FDA - Food and Drug Administration
added Dec 14, 2016 19:53
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