Swedish March does not make dissolvable tobacco products; however they are interested in the field of harm reduction. Swedish Match submitted the attached comments to FDA in response to a Federal Register Notice.
Swedish Match states:
Envrion International Consulting is preparing a report on the patterns of use of Swedish snus and smokeless tobacco in the US.
The report will also address the topic of whether smokeless tobacco is a gateway to cigarette smoking.
That TPSAC should begin work on modified risk criteria.
The Center for Regulatory Effectiveness (CRE) has notified the FDA that the smoking initiation/cessation studies identified by the FDA and reviewed by CRE can not be used to formulate a policy on menthol cigarettes.
The Data Quality Act prohibits federal agencies from using studies that are non-compliant with the DQA. The FDA has sixty days to respond to the CRE petition.
In its petition CRE painstakingly reviews eight of the studies identified by the FDA and explains the reasons for their non-compliance with the Data Quality Act.
In its petition CRE states:
In this article, the Wall Street Journal Reports:
GlaxoSmithKline PLC called for the U.S. government to remove so-called dissolvable smokeless-tobacco products from the market, a move that shows emerging battle lines between pharmaceutical and tobacco companies aiming to sell alternatives to cigarettes.
Dr. Lawrence Deyton, director of the FDA’s Center for Tobacco Products, sent letters in February to both Reynolds and Star Scientific in which he expressed concern that dissolvable tobacco lozenges, strips and sticks are candy-like in appearance and may appeal to the youth market.
Some public-health groups have argued that the newer products may represent a promising way to help wean smokers off cigarettes. But groups including the Campaign for Tobacco-Free Kids have voiced concern that the products could hook more Americans on nicotine.
Scientific studies have shown that smokeless tobacco products are significantly less harmful than cigarettes. Smokeless tobacco still carries risks, including the potential to raise blood pressure and contribute to the development of cardiovascular disease.
Those having views and scientific studies on this matter should post them on this Forum.
Source: Wall Street Journal http://online.wsj.com/article/SB10001424052748703694204575518294130892622.html
CRE continues to review reports identified by FDA in the menthol proceeding.
CRE has previously completed analyses of several other studies and the results are published in this Forum.
Attached hereto is the CRE analysis of the following study: TPSAC Pletcher
TPSAC Pletcher
CRE continues to review reports identified by FDA in the menthol proceeding.
CRE has previously completed analyses of several other studies and the results are published in this Forum.
Attached hereto is the CRE analysis of the following study:TPSAC Ghandi
TPSAC Ghandi
