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Headlines Tagged with FDA 8,981 headlines found


FDA denies Swedish Match request on tobacco warning label changes

The FDA said it denied the request to remove the gum disease and tooth loss warnings because, based on the scientific evidence, “the products can cause gum disease and tooth loss.” However, the agency deferred a final decision on the mouth cancer warning
Richmond (VA) Times-Dispatch
added Dec 17, 2016 06:54
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US drops bold warning from anti-smoking pills Chantix, Zyban

The FDA decision stems from an 8,000-patient study of smokers that found no elevated risk of psychiatric problems among Chantix users who had no prior history of mental illness. European regulators previously removed their own warning from the drug based
AP - Associated Press
added Dec 17, 2016 06:47

SULLUM:The FDA Keeps Us Guessing About the Scope of Its E-Cigarette Regulations

But I can't see how the FDA statement cited by Tully's company, which addresses (or avoids addressing) nicotine-free e-fluids and is similar to maddeningly vague statements the agency has made before, makes the project any more promising.
Reason Magazine
added Dec 17, 2016 03:11

Modified Risk Tobacco Product (MRTP) Application - Technical Project Lead (TPL) Review (PDF)

With respect to the request to remove the gum disease and tooth loss warning, based on the available scientific evidence, SMNA has not demonstrated that, as actually used by consumers, the products sold or distributed with the proposed modified risk info
FDA - Food and Drug Administration
added Dec 16, 2016 22:30

MRTP Application Actions (Orders, Denials, and Responses)

FDA - Food and Drug Administration
added Dec 16, 2016 21:30

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

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

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
added Dec 16, 2016 19:39

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

SIEGEL: D.C. District Court Should Issue an Immediate Injunction Against Enforcement of FDA Deeming Regulations

The FDA deeming regulations do not allow that e-cigarette company, or any of the multiple others whose batteries have exploded, to replace the cheap aftermarket batteries with safer ones. If they did so, it would constitute a new "tobacco product," and c
The Rest of the Story-Tobacco Analasys and Commentary (Michael Siegel blog)
added Dec 16, 2016 18:38
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