Hr 1256 what does this mean

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martha1014

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H. R. 1256—9
‘‘(4) A tobacco product shall not be marketed in combination
with any other article or product regulated under this Act (including
a drug, biologic, food, cosmetic, medical device, or a dietary supplement

Exactly what does this mean.



http://frwebgate.access.gpo.gov/cgi-...256enr.txt.pdf

Is SE and Njoy trying to say Ecigs are a tobacco product and/or smokeless tobacco.

I am a little confused after reading the entire HR 1256 bill.

Can anyone help expain this to me?
 

Enigma32

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The FDA has tried regulating cigarettes in the 90's, which the United States Supreme Court had ruled that congress had set regulations over cigarettes contradictory to their overisight, especially in that the FDA would've had to by their own rules and standards BAN all tobacco, whereas law actually protected the industry as vital to the economy and a ban would present more danger to the public than benefit to it.
The bill sets forth standards for granting the FDA authority over cigarettes and tobacco products, restricting or denying new products from introduction, while at the same time protecting existing products.
If you read it through as I've been the last few days it does in fact make e-cigarettes illegal as they are a tobacco product as defined by it, but were not an existing product marketed in the united states prior to february 15th 2007 (exactly two months before ruyan started exporting as ive learned)
Also, they are not defined as a smokeless tobacco product as defined in the act either. They actually don't fall into ANY category besides "tobacco product" basically meaning "your under our control, but not given a green light to sell despite that"
 

yvilla

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Here is the FDA's draft guidance document, explaining what this means:

Draft Guidance: The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act

Edit: As for the second part of your question Martha, yes SE and Njoy are arguing in federal court that their products should be categorized as "tobacco products" under the new tobacco products legislation.

If they win that argument, then the question becomes precisely what sort of "tobacco product" - "modified risk", "reduced exposure"?? - and also exactly how ecigs will ultimately end up being regulated under the new law. Manufacturers (or US sellers) will definitely have to go through substantial regulatory and legal hoops if they are ever to be approved for lawful sale.
 
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