FDA Seeks Comments in Changes to Smokeless Health Warnings

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Vocalek

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It's no joke. This is every bit as important as other times we've commented on an FDA notice. The required warnings are mostly lies, and we should be demanding they change the warnings to something more truthful.

On the page below, click the "Comment Now!" button to leave a comment.

Regulations.gov

WHY THIS IS IMPORTANT

The pharmaceutical companies are asking the FDA to approve NRTs for long-term use. Guess what they are using as proof that long-term use of nicotine would not endanger health? All the evidence about the health effects of smokeless tobacco!

This was the original presentation to the FDA about smokeless tobacco NOT causing cancer, heart attacks, or strokes. http://www.fda.gov/downloads/Drugs/NewsEvents/UCM232147.pdf

So if Big Pharma can extrapolate from scientific information on the safety of smokeless tobacco to prove that long-term use of their products wouldn't be harmful, quite obviously that same evidence proves that smokeless tobacco is low-risk, and anything that delivers nicotine without the smoke (e.g. e-cigarettes) would be as well.

See:
FAQ: Smokeless Tobacco (tobaccoharmreduction.org)
FAQ: Health Effects (tobaccoharmreduction.org)

Also see: For Smokers Only

This article lists 105 scientific journal articles in the References Section. HRJ | Full text | The Scientific Foundation for Tobacco Harm Reduction, 2006-2011

Summary:
Only one of the four labels is truthful: WARNING: Smokeless tobacco is addictive.



Here is the background for the FDA's Request for Comments:

SUPPLEMENTARY INFORMATION:

I. Background

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control Act) into law. The Tobacco Control Act grants FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors.
Section 204 of the Tobacco Control Act amended section 3 of the Comprehensive Smokeless Tobacco Health Education Act Smokeless Tobacco Act) (15 U.S.C. 4402) to prescribe new requirements for health warnings that must appear on smokeless tobacco product packages and advertising.
The Smokeless Tobacco Act (15 U.S.C. 4402(a)(1) and (b)(1)), requires that smokeless tobacco product packages and advertising must bear one of four required warning statements. The four required warning statements are:
``WARNING: This product can cause mouth cancer.''
``WARNING: This product can cause gum disease and tooth loss.''
``WARNING: This product is not a safe alternative to cigarettes.''
``WARNING: Smokeless tobacco is addictive.'' (15 U.S.C. 4402(a)(1))
One of the four required warning statements must be located on each of the two principal display panels of the package and comprise at least 30 percent of each such display panel (15 U.S.C. 4402(a)(2)(A)).
The Smokeless Tobacco Act (15 U.S.C. 4402(a)(2) and (b)(2)), also sets forth requirements for the placement, type, size, and color of warnings on packaging and advertisements, respectively.
Section 205(a) of the Tobacco Control Act further amended section 3 of the Smokeless Tobacco Act to give FDA the authority to ``adjust the format, type size and text of any of the label requirements, require color graphics to accompany the text, increase the required label area from 30 up to 50 percent of the front and rear panels of the package, or establish the format, type size, and text of any other disclosures required under the Federal Food, Drug, and Cosmetic Act'' through
rulemaking conducted under the Administrative Procedures Act (5 U.S.C. 552, et seq.) if FDA ``finds that such a change would promote greater public understanding of the risks associated with the use of smokeless tobacco products'' (15 U.S.C. 4402(d)).

II. Request for Scientific Evidence and Information

We are interested in comments, supported by scientific evidence, regarding what changes, if any, to the smokeless tobacco product warnings would promote greater public understanding of the risks associated with the use of smokeless tobacco products. The ``public'' includes both tobacco users and nonusers (i.e., never users and former users). Comments and supporting evidence should address how any changes in the warnings would affect both users' and nonusers' understanding of the risks associated with the use of smokeless tobacco products.
 

rothenbj

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Jul 23, 2009
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I say we get a group together and file for an extension beyond April 1st. Citing a desire to ensure completion of current, um, scientific studies that will greatly assist in providing the requested information. Something in the neighborhood of 90 days extension ought to do it.

I'd request the extension just on the fact that the FDA IS an April Fools joke.
 

Luisa

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Apr 8, 2010
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harlingen,texas
It's no joke. This is every bit as important as other times we've commented on an FDA notice. The required warnings are mostly lies, and we should be demanding they change the warnings to something more truthful.

On the page below, click the "Comment Now!" button to leave a comment.

Regulations.gov

WHY THIS IS IMPORTANT

The pharmaceutical companies are asking the FDA to approve NRTs for long-term use. Guess what they are using as proof that long-term use of nicotine would not endanger health? All the evidence about the health effects of smokeless tobacco!

This was the original presentation to the FDA about smokeless tobacco NOT causing cancer, heart attacks, or strokes. http://www.fda.gov/downloads/Drugs/NewsEvents/UCM232147.pdf

So if Big Pharma can extrapolate from scientific information on the safety of smokeless tobacco to prove that long-term use of their products wouldn't be harmful, quite obviously that same evidence proves that smokeless tobacco is low-risk, and anything that delivers nicotine without the smoke (e.g. e-cigarettes) would be as well.

See:
FAQ: Smokeless Tobacco (tobaccoharmreduction.org)
FAQ: Health Effects (tobaccoharmreduction.org)

Also see: For Smokers Only

This article lists 105 scientific journal articles in the References Section. HRJ | Full text | The Scientific Foundation for Tobacco Harm Reduction, 2006-2011

Summary:
Only one of the four labels is truthful: WARNING: Smokeless tobacco is addictive.



Here is the background for the FDA's Request for Comments:
bump bump bump
 

Petrodus

Vaping Master
ECF Veteran
Oct 12, 2010
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So now commenters can only comment when they can supply scientific evidence.
They learned a lesson from those over 5,000 comments on the NRT item.
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