Good Article at realclearpolitics

[Grimwald]

Congress, Please Make Smoking Less Harmful. | RealClearHealth

 

[Bill Godshall]

And another one.

Nitzkin/Rodu: FDA should get out of the smokeless tobacco industry
FDA should get out of the smokeless tobacco industry

 

[Rossum]

The FDA readily admits that meeting the new standard likely would require manufacturers to use different types of tobacco and change how that tobacco is processed. Under provisions of the Tobacco Control Act of 2009, new or modified tobacco products cannot be brought to market without explicit FDA approval. The law makes no exception for modifications that are mandated by FDA and the FDA's proposed rule doesn't mention any waivers from the law. Complying with the pre-market application process likely will take more than two years to prepare and cost manufacturers more than $1 million, with separate applications required for each version of the revised product, as defined by flavor, nicotine level and labeling.

So they're basically going to kill all the traditional smokeless products.

 

[Bill Godshall]

So they're basically going to kill all the traditional smokeless products.

FDA's proposed nitrosamine standard of 1 part per million
would ban about 95% of all smokeless tobacco products now sold in the US. Only Swedish snus and several chewing tobacco brands are currently below that level.

And yet, FDA's PATH survey found (in 2013/14) that 3.2 million Americans (mostly non urban white males) currently use both smokeless tobacco and smoke cigarettes (dual users), many of whom will increase their cigarette consumption if FDA's smokeless tobacco standard/ban is approved and implemented.

But I think we can convince DHHS and FDA appointees of Trump to reject this disastrous proposal, just as I think
we can convince DHHS and FDA appointees of Trump to reject the similarly disastrous Deeming Regulation.

 

[Rossum]

Reducing nitrosamines in oral tobacco products is surely a laudable goal, but promulgating a regulation that kills off granfathered tobacco products and forces their manufacturers to to file PMTAs or MRTP applications for the replacement products, with no assurance that such applications will be approved is not the way to go about this.

 

[Bill Godshall]

Even if FDA doesn't require PMTAs for smokeless tobacco products that are changed to comply with their proposed nitrosamine standard, it is very likely that some/many/most smokeless tobacco users won't like and may not use the newly designed products.

Many of the 3.2 million dual users (of smokeless and cigarettes) would likely increase their cigarette consumption (in response to FDA's smokeless standard), which would increase their disease risks.