Skip to comments.Comment on FDA's proposed deeming regulations on e-cigs. 75 days public comment period has started.
Posted on 04/25/2014 12:29:18 PM PDT by 1_Inch_Group
Regulation of Electronic Cigarettes by the FDA
By Mitch Zeller, the Director of the Food and Drug Administration's Center for Tobacco Products.
Thank you for
your petition on electronic cigarettes .
First things first: While we are seeking to regulate products like electronic cigarettes, the proposed regulation would not ban them.
Some background, which you may already know: The
Family Smoking Prevention and Tobacco Control Act that Congress passed in 2009 gave the FDA immediate authority to regulate certain tobacco products -- cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco -- under the
Federal Food, Drug, & Cosmetic Act . And while it didn't apply right away to other tobacco products, such as electronic cigarettes, the law gave the FDA authority to cover those products through regulation.
issued a proposed rule to allow the FDA to regulate those products in the April 25, 2014 issue of the Federal Register. Electronic cigarettes containing nicotine derived from tobacco would meet the statutory definition of "tobacco product" and so they'd be subject to the FD&C Act when the proposed rule is finalized.
Now the petition states that
sections 905 and
910 of the FD&C Act would "ban all e-cigarettes," and that's not true.
If the FDA finalizes the rule in its current form, electronic cigarettes manufacturers will need authorization to sell products not commercially marketed as of February 15, 2007 -- but this doesn't mean these products would be banned. Sections 905 and 910 describe the applications and reports manufacturers will need to submit to sell their products.
There will be two primary ways for tobacco products to obtain that authorization: either an application for "substantial equivalence," or an application for premarket approval.
"Substantial equivalence" would ask manufacturers to compare their products to another product that was already commercially marketed by February 15, 2007 or that was previously found by FDA to be substantially equivalent -- though we acknowledge this may be challenging for electronic cigarettes. Second would be the premarket tobacco application, where a manufacturer submits information to the FDA establishing it would be "appropriate for the protection of public health" to allow the product to be marketed.
We know that those applications may require time and resources to develop. That's why the FDA does not intend to take legal action against manufacturers for marketing their products without prior authorization until the FDA issues its decision on the application -- so long as the manufacturer gets its application in within two years and thirty days after the final rule is published. Our hope is to provide manufacturers flexibility as the FDA completes its review.
So why are we seeking to regulate these products in the first place? As we discuss in the proposed rule, though all tobacco products are potentially harmful and potentially addictive, different categories of tobacco products may have the potential for varying effects on public health. There's still a lot we don't know about these products, and this rule will expand the amount of information available to the FDA and the public -- that's good for everyone.
Some people believe that e-cigarettes may help smokers quit smoking and that switching from regular cigarettes to e-cigarettes may reduce exposure to harmful components and constituents in cigarette smoke. But again, we don't know enough to make that call. This rule would help us to continue to analyze the potential benefits and risks of e-cigarettes, including their impact on nonusers and on the population as a whole.
It's important to remember that this rule isn't final yet, though. We're seeking comments on the proposed rule as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products, and the potential benefits and risks associated with e-cigarettes.
opportunity to comment on FDA's proposed rule is now open and comments are due on July 9, 2014. We encourage you to do so, and to provide any data and information you may have to support your comments.
Please share your experiences, your knowledge, and counter their incorrect thought processes. Link to comment is at the bottom of the email I received today from whitehouse.gov
(SORRY for the links showing up as they did. Perhaps someone with a little HTML-fu can create actual clickable links from that mess?)
It’s about the money... If e-cigs prove to be innocuous, or at least far less harmful than tobacco, they’re a relative benefit. Tax it!
Anyone who thinks this is being done for any reason other than money is deluded. This is the camel’s nose under the tent, by which e-cigs will be regulated until they are as ineffective at helping people quit smoking as the existing pharmaceutical approaches, whose performance barely outdoes placebos, but which are 100% effective at generating hundreds of millions of dollars for the politically connected.
I think E-cigs are great, but should be limited to 18 and older.
I do not understand the people that want to BAN E-cigs on the basis that flavors will entice children.
Just make it 18 and older.
They have been selling peach schnapps for hundreds of years.
That could certainly be accomplished at a state level: no need to involve the feds.
I agree, but the FDA does not.
This really doesn’t have a damn thing to do with the FDA wanting to regulate E-cigs, that is just an excuse to change what they did in 2009.
Not mentioned here is the fact that they plan to add the 2500% tobacco tax on pipe tobacco and cigars.
They were losing to much in taxes on roll your own tobacco, and want another bite at the apple to correct their mistake.
They are using E-cigs as an excuse to slip that in.
It’s about some people loving the idea of power and control over others. It has nothing to do with health or safety, and has a LOT to do with money.
I think you’ll agree it’s a matter of when, not if. And the extent to which the gov’t overreaches. They should ban sales to <18 yr olds, implement the same advertising limits as tobacco products, and implement severe penalties for offering anything other than nicotine-based products. And there should be ongoing testing because it’s a drug delivery device and the long term effects are unknown.
Where did your information come from?
How does one make an effective product ineffective? Are you proposing that they’ll force manufacturers to remove the nicotine?
My mother, father, brother, his girlfriend, my mother in law and my wife have all kicked the habit thanks to e-cigarettes. This is completely and totally about money. The government sees these as a threat to their tobacco tax revenues and now they want to regulate them to get in on the action.
What a farce!
e-cigs are a threat to Big Government, Big Tobacco, and Big Pharma. They will be crushed by regulations.
If the left wants to ban E-cigs because it looks too much like real cigs then they must hate all long, slender things in their mouths.
I guess they’ll ban homosexuality next! /s
They are NOT a tobacco product, so by what reason can/should they be regulated under any tobacco law?
What is the significance of February 15, 2007 for the substantial equivalence test? Is this an arbitrary baseline date, or was there a landmark ruling? I don’t get it.
They are NOT a tobacco product and considering them as such makes no sense whatsoever. Also, many of the mixes you can use in them contain no nicotine at all.
Nicotine gums and patches are drug delivery devices and advertise all over the TV and radio and the long term effects are unknown.
BTW, I’ve never used an e-cig or any pharmaceutical nicotine delivery device and the majority of my nicotine consumption nowadays comes from my roasted or mashed potatoes, roasted pepper laden pizza, and eggplant parmigiana.
The FDA pushes them - at the behest of their overlords in the pharmaceutical industry and the pharma puppets in congress go along with them.
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