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Headlines Tagged with Swedish Match 1,049 headlines found

14 Views

RODU: FDA Rejects Plea to Correct Smokeless Tobacco Warnings; A Closer Look at Flawed Interpretations

nter for Tobacco Products rejected Swedish Match’s request... The FDA justified its rejections in a six-page letter to the company (here) in a 115-page supporting document (here), and subsequently in an announcement proclaiming, “FDA Issues Science-Based
Tobacco Truth (Brad Rodu blog)
added Dec 23, 2016 14:07
8 Views

BOEHM: Safer Alternative to Smoking Can’t Call Itself a Safer Alternative to Smoking

Approving Swedish Match's application to pitch snus as a safer alternative to smoking would probably save American lives, but it would create more competition for Nicorette gum and other pharmaceutical stop-smoking products like Chantix. It's worth noting
Reason Magazine
added Dec 21, 2016 22:40
4 Views

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

On December 14, 2016, we denied Swedish Match North America Inc.’s request to remove one of the required warning statements for eight General snus products....Below, we explain the scientific review process and what was considered in taking these actions
FDA - Food and Drug Administration
added May 24, 2017 22:16
7 Views

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

we denied Swedish Match North America Inc.’s request to remove one of the required warning statements for eight General snus products. We also provided recommendations related to the applicant’s other requests...Below, we explain the scientific review pro
FDA - Food and Drug Administration
added Dec 20, 2016 22:31
8 Views

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
11 Views

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 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
5 Views

LETTER to SWEDISH MATCH from FDA (PDF)

we are not issuing modified risk orders...with respect to your requests to remove the mouth cancer warning and revise the “not a safe alternative” warning. We have determined that in their present form, the applications do not contain sufficient evidence
FDA - Food and Drug Administration
added Dec 23, 2016 14:06
6 Views

MRTP Application Actions (Orders, Denials, and Responses)

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