Thursday, May 8, 2014

CASAA's Basic Background for Understanding FDA Regulation of E-Cigarettes

8 May 2014

CASAA’s Basic Background for Understanding FDA Regulation of E-Cigarettes



FDA’s release of the draft deeming regulations has caused an explosion of interest in the law and politics relating to e-cigarettes among those who have not followed the topic previously.  Some are new to the entire world of vaping-related chatter, while others have been immersed in the social media but have never understood the governance side.  Here are some very basic facts for getting up to speed and trying to take effective action.


  • In 2010, a federal court ruled that FDA could not regulate e-cigarettes as medicines unless therapeutic claims were being made in marketing.  It suggested that the FDA had the option of asserting authority over them as tobacco products.  (Contrary to how it is sometimes interpreted, the ruling did not give FDA that authority directly, nor did it say they had to take it.) That assertion of authority is what is happening now.
  • There is no serious doubt that, under the Family Smoking Prevention and Tobacco Control Act (TCA), that the FDA has the authority to regulate the nicotine liquids currently used in electronic cigarettes.  There is no point in trying to argue that these products are not technically tobacco (they clearly meet the definition of “tobacco products” in the TCA), nor that FDA cannot do this (they can).  There are, however, arguments to be made that FDA should not exercise its available authority (either in whole or in part).
  • FDA has a great deal of flexibility about how they regulate tobacco products that are already under their purview, as well as the products that they are in the process of “deeming” to be tobacco products. However, the TCA imposes some limits on their flexibility.  (The full details of how those break down are complicated, but it is useful to just know that this is the case.)
  • Specifically, declaring various products to be tobacco does not mean that they will all be treated the same.  Unfortunately, the low-risk products that FDA already regulates (smokeless tobacco) have basically been treated the same as cigarettes.
  • One of the biggest concerns about the FDA process is that it is already broken.  The main approval process that e-cigarettes and other new products would have to go through is already in place for cigarettes and smokeless tobacco, and it is failing miserably, with an enormous backlog of applications that they have failed to act on.  Moreover, the separate approval process available for introducing a product because it is low risk, or allowing low-risk claims to be made, is so onerous that it has never been applied.
  • Other major concerns have been identified in the CASAA blogs.  Watch those for further information. (blog.casaa.org, antiTHRlies.com)
  • There are different interests at play here. CASAA and a few other advocates represent consumers, while other organizations represent the industry.
    • CASAA believes that consumers are best served by ensuring diversity in the marketplace, namely, many different devices as well as a variety of liquid flavors and strengths.  Many of the loudest voices represent industry interests, which are often not the same as consumer interests.  
    • Within industry, there are also varying interests.  Smaller manufacturers (boutique hardware and liquid manufacturers; specialty retailers) seem to have interests closely aligned with consumers, since the main harm to consumers from the proposed regulations would be putting them out of business (and destroying market diversity) as a result of the approval process.  
    • Large manufacturers, particularly NJOY and Johnson Creek, who might benefit from the lack of competition, have come out in favor of the proposed regulations.  (Note that there is some disagreement about whether they really would benefit.)
  • The deeming regulation process is slow-moving.  There is a 75-day comment period (which we hope will be extended), followed by some time for FDA to issue the final regulations.  If the final regulations are similar to the draft, there will be two years after that before the most harmful provisions take effect.
  • However, other rules could be issued during that two year grace period.  For example, the draft regulations overtly seek comments that would provide justification for banning flavors.
  • It seems likely that the details will ultimately be decided by the courts.  It is important that the messaging be done with that in mind.


There are several ways consumers can effectively respond to this proposal.  
  • CASAA will be issuing guidance for consumers about how to effectively comment on the FDA process directly.  We will also issue suggestions about contacting members of Congress and others who might influence this process.
  • Consumers should also join CASAA (numbers matter!), encourage others to do so, and encourage your vendors to encourage their customers to do so. Watch the CASAA main blog or our social media for updates.
There are also several rather ineffective ways to respond.  
  • Except perhaps at the local level, petitions are generally pointless, accomplishing nothing even when they are sensible.  They tend to give the illusion of having done something, dissipating energy that could be directed usefully.  Even worse are inaccurate and otherwise flawed petitions that just send the message that vapers need to be regulated because they apparently do not understand matters well enough to look out for themselves.  
  • Submitting comments early and without an informed strategy is unlikely to be useful, and is potentially harmful. There is no advantage to submitting comments early rather than waiting for strategy and guidance. Lashing out in ways that do not speak the right language is as bad as or worse than signing a bad petition.

19 comments:

Grey Piffle said...

Do we have an estimate as to when CASAA will have the proposed guidance for responding? I have been working on my response bit by bit, but any additional information would be helpful before I submit.

Grey Piffle said...

Sorry, real name is Ken Anderson... Just the google has my userid.

Kristin Noll-Marsh said...

See our follow-up post here: http://blog.casaa.org/2014/05/overview-of-casaas-action-plan.html

Anonymous said...

I am a Vaper & have not had a cigarette in 4 Months & Sincerely believe that the FDA should extend the 75 day window for we have rights also & Smoking is bad for you & I believe Vaping is ok & I enjoy it

Victoria Smith said...

I will do everything in my power to fight for vaper's rights. It is not ok that poisons are legal and something that is truly beneficial is in danger of being halted.

7ddb51be-e175-11e3-a6b6-87412d072d5d said...

As a physician familiar with these products for 5 years, and having counseled countless patients about smoking, I can state without an ounce of reservation that no product I know of has the potential to save more lives than these vapor products. Patches, pills, gums, etc. have absolute dismal long-term success rates. Vapor products work. I find it both ironic and troubling that the one cessation product that actually works is the one product that cannot be marketed as such. There are hundreds of thousands who have found these products to be life altering life savers, yet their biggest fear is their own government. While I generally support our FDA, I find this very disturbing. The issue is apparently filled with special interests, and I believe our government should place the best interest people first - people who have finally been successful in quitting actual cigarettes, which are deadly.

Anonymous said...

Why not do what was done in Europe... simply identify politicians that are anti ecig and remove them in an election by strategically voting for folks (even if you utterly disagree with their politics)

You don't think for example that the Irish really do support random independent individuals standing for elections. They got 30% of the seats in EU elections recently... They voted for these as an alternative... it was organised protest that had the effect of utterly screwing over the entire EU, and like the Arab spring organised over social media.

UK citizens don't actually agree with the new political part UKIP, again this was a deliberate organisation of voters who can now share their intentions online.

I'd say 20 or 30 long standing congress members and whatnot in the trashcan never to be reelected with the trail observably leading back to an organised campaign to slap politicians that don't do as they are told would more or less do the trick. There are 3 million vapers in the US, all adults, all voters...that's enough to swing lots of votes but vapers have to all pick someone and vote for them so that the swing all goes in one direction. Pick a random guys on the street standing and vote for them regardless of their political ideology.

Anonymous said...

Moron. Everything can be used as poison in the right quantities, what makes rat poison legal and unregulated but tobacco regulated and thc illegal. You can die of aspirin etc etc...

THIS is what you get when you let the government regulate one single item, soon even bottled water will be regulated, mark my words.

Anonymous said...

I am very surprised it has taken so long for them to outlaw it... Stocking up on batteries and liquids now...

Anonymous said...

BAN THEM

Anonymous said...

IM GLAD YOUR NOT MY DOCTOR

Anonymous said...

this has helped me so much have not smoked a cigarette since dec2013 nothing else helped

Anonymous said...

TO:"BAN THEM" Morons abound!

Anonymous said...

Ironically; Bottled water is more dangerous to humans as a species than the less than 00.1% of total population who use e-cigs.. All that plastic! Millions of tons per day! Not just the bottles but the manufacturing toxic waste created too!

WisKid said...

I could see e-cigs being a voting issue along the lines of how guns are treated.

About 80% of the population wanting some basic safety regulations, ten percent wanting no regulations whatsoever, and 10% wanting them outlawed entirely.

Besides workers rights and dirty money in politics vaping is probably my third biggest voting issue. I suppose the dirty money/vaping thing are pretty closely tied.

Shaun Matone said...

I don't understand why they want to ban flavors of eliquid. What about flavored chewing tobacco, flavored cigars and flavored blunt wraps, flavored vodka along with many other flavored alcohol and tobacco products.

ilvpainting said...

Absolutely agree with the Dr. I would still be smoking if it wasn't for vaping...I haven't touched an analog cig since Jan. 26, 2012 - the day I rec'd my first kit.!!! There are too many people in our corrupt government that have their hands in the tobacco co's pockets..sickening

Anonymous said...

I haven't had a analog cig since 5-1-2009 and have gone from 24 nic to 6 mil of nic in my ejuice. As the Doctor states it is a fact that nothing else worked for me. Not the patch not the gum not the spray, and not even hypnosis. I was a pack a day smoker since I was 13 years old. I am now 55. Have good health a lot of energy, cough is gone, I gained weight again damn for that and anyways nothing stinks. This is the only thing that has worked for me. I am so angered by the fda wanting to ban the use of ecigs and the flavored juice. It makes me sick that all they want is to help BIG PHARMA, and the tobacco industry stay rich and get even richer. They are crooks just like all of government.Kids will still drink and smoke cigs and they know it. They say it's for the kids. LIARS AND THEY KNOW IT. THEY'RE NOT MAKING ANY MONEY FROM THE ECIG BUSINESS SO THAT'S WHY THEY WANT TO GET THEIR DIRTY ASS PAWS ALL OVER THIS.

Junebugg said...

I don't understand what to do. I did the stuff CASAA said to do. I wrote my congressmen and local city officials before on this issue. I only received one reply. The ban passed anyway. I won't go to city meetings or that type of thing. But I will make calls and write emails. I don't mind being involved, but what else can I do? It seems like our viewpoints don't mean diddly to the government.