The FDA posted
[h=2]Draft Guidance for Industry; Availability: Modified Risk tobacco Product Applications[/h]
Regulations.gov
Today, June 4, 2012 is the last day to post comments. If we say nothing, this will go through as the FDA described, with only (perhaps) the requirement for animal testing removed, since there are over 500 comments from PETA members and other animal rights activists.
WHAT IT IS
Currently, it is illegal for any tobacco product manufacturer or seller to claim that a particular product is less hazardous than any other tobacco product. For example, there are decades of peer reviewed scientific journal articles pointing out that smokers who switch to snus (a type of moist snuff) greatly reduce their risks of smoking-related diseases. But in the US, there are government-required warning labels that must go on all smokeless tobacco products. Three of these labels are very misleading:
There is no scientific evidence that modern western (US & Europe) smokeless products cause gum disease, or tooth loss, or increase risks for mouth cancer over and above that of non-users of tobacco. Since it is smokeless, all smoking-related risks of lung disease are eliminated (this represents 58% of annual mortality rate from smoking.) Smokeless is not 100% safe, but saying that it is not a "safe alternative to cigarettes" gives the false impression that it is just as hazardous to health as smoking.
It is illegal for a manufacturer or vendor to make any statements about health related to a tobacco product.
The Draft Guidance describes the battery of testing, ranging from toxicology tests on chemicals in a product, all the way through and beyond clinical trials, that a manufacturer must perform in order to be able to advertise that the product is a "modified risk tobacco product."
WHAT ABOUT E-CIGARETTES?
Currently, the FDA does not regulate e-cigarettes as a tobacco product, but as soon as the FDA issues a "deeming regulation" stating that the Agency is going to regulate ALL tobacco products under the Family Smoking Prevention and Tobacco Control Act, then this regulation will apply to e-cigarettes as well.
WHY IS THIS A PROBLEM?
The battery of tests will cost millions of dollars to perform and take several years. And after all that, it is possible that the FDA would deny the application.
People are dying every day of smoking-related diseases. This death toll could be reduced greatly if manufacturers and sellers were permitted to tell smokers the truth: Switching to a smoke-free alternative source of nicotine will eliminate most of the smoking-related health risks of tobacco use.
HOW YOU CAN HELP
Click the link above to go to the regulations page. Click the large blue button at the top right of the page that is labeled Comment Now!
Write a statement urging the FDA to create a "Fast Track" method to award Modified Exposure and/or Modified Risk status for for classes of products that have been on the market for years and which have been shown to be less hazardous to health than smoking.
CASAA's comment letter can be viewed here: CASAA: CASAA's comment on FDA Draft Guidance for Modified Risk Tobacco Product Applications
[h=2]Draft Guidance for Industry; Availability: Modified Risk tobacco Product Applications[/h]
Regulations.gov
Today, June 4, 2012 is the last day to post comments. If we say nothing, this will go through as the FDA described, with only (perhaps) the requirement for animal testing removed, since there are over 500 comments from PETA members and other animal rights activists.
WHAT IT IS
Currently, it is illegal for any tobacco product manufacturer or seller to claim that a particular product is less hazardous than any other tobacco product. For example, there are decades of peer reviewed scientific journal articles pointing out that smokers who switch to snus (a type of moist snuff) greatly reduce their risks of smoking-related diseases. But in the US, there are government-required warning labels that must go on all smokeless tobacco products. Three of these labels are very misleading:
- 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.
There is no scientific evidence that modern western (US & Europe) smokeless products cause gum disease, or tooth loss, or increase risks for mouth cancer over and above that of non-users of tobacco. Since it is smokeless, all smoking-related risks of lung disease are eliminated (this represents 58% of annual mortality rate from smoking.) Smokeless is not 100% safe, but saying that it is not a "safe alternative to cigarettes" gives the false impression that it is just as hazardous to health as smoking.
It is illegal for a manufacturer or vendor to make any statements about health related to a tobacco product.
The Draft Guidance describes the battery of testing, ranging from toxicology tests on chemicals in a product, all the way through and beyond clinical trials, that a manufacturer must perform in order to be able to advertise that the product is a "modified risk tobacco product."
WHAT ABOUT E-CIGARETTES?
Currently, the FDA does not regulate e-cigarettes as a tobacco product, but as soon as the FDA issues a "deeming regulation" stating that the Agency is going to regulate ALL tobacco products under the Family Smoking Prevention and Tobacco Control Act, then this regulation will apply to e-cigarettes as well.
WHY IS THIS A PROBLEM?
The battery of tests will cost millions of dollars to perform and take several years. And after all that, it is possible that the FDA would deny the application.
People are dying every day of smoking-related diseases. This death toll could be reduced greatly if manufacturers and sellers were permitted to tell smokers the truth: Switching to a smoke-free alternative source of nicotine will eliminate most of the smoking-related health risks of tobacco use.
HOW YOU CAN HELP
Click the link above to go to the regulations page. Click the large blue button at the top right of the page that is labeled Comment Now!
Write a statement urging the FDA to create a "Fast Track" method to award Modified Exposure and/or Modified Risk status for for classes of products that have been on the market for years and which have been shown to be less hazardous to health than smoking.
CASAA's comment letter can be viewed here: CASAA: CASAA's comment on FDA Draft Guidance for Modified Risk Tobacco Product Applications
