Friday, April 25, 2014

CASAA Assessment of FDA Deeming Regulation, April 25, 2014



Yesterday’s FDA draft deeming regulation regarding e-cigarettes, other smoke-free alternatives, and other products is not as bad on its face as it might have been. However, a full review -- in the context of background knowledge and institutional analysis -- reveals that the proposed regulation is inappropriate, ill-founded, and potentially devastating for consumers.


1. The proposed regulation of non-combustible tobacco products, particularly including e-cigarettes, does almost nothing to address any real problems.


With the exception of ingredient labeling requirements, which benefit consumers, and bans on sales to minors, which we also support, this appears to be a classic case of a solution in search of a problem. FDA presents only speculative claims of harms or risks from smoke-free products.  To the extent that they identify potential problems, there is no reason to believe that the proposed regulations will address them.  


For example, there are vague assertions that regulation will address problems of unsanitary manufacturing processes or contamination. Addressing these would benefit consumers. But the regulations, which primarily involve busy-work information filings and applications, would do nothing to address such problems. Another example is the repeated claims about fixing consumer misperceptions. There is no evidence that consumers are misinformed. But even if they are misinformed, there is no apparent way the proposed restrictions would change that. Indeed, we believe the proposed regulations would increase confusion.


FDA implies that their filing and application processes address these speculative problems, but they do not. They would have us believe that their HPHC (hazardous and potentially hazardous chemicals) reporting process, where manufacturers are required to measure and catalog the quantities of a list of chemicals in products, is a solution. But such reporting is nearly useless for educating consumers, as was made clear when FDA and TPSAC discussed how to try to make it useful in a meeting last year. It does nothing to prevent occasional contamination problems and is not sufficient knowledge for determining which products might pose higher risks, though it will inevitably be interpreted as such.


Similarly, they declare that their application process for allowing new or “substantially equivalent” products onto the market protects good products and eliminates bad ones. But there is no evidence that their process actually accomplishes this. Moreover, that process is hopelessly backlogged merely trying to regulate cigarettes and smokeless tobacco; they will be even less capable of dealing with applications about far more complicated and varying e-cigarettes. FDA actions, discussions, and statements about the approval process strongly suggest that for manufacturers to get filings approved, they will have to provide information that is next-to-impossible to produce.


2. There is no recognition of consumer interests.


The consumers are the primary stakeholders in this process, yet FDA displays an utter disregard for their interests. Discussions of the cost of the proposed regulations focus entirely on the compliance costs for manufacturers. There is no apparent awareness of the costs imposed on consumers. It is telling that the logon password for yesterday’s FDA phone broadcast about the regulations was “industry.”


There are signals that FDA would take actions that are harmful to consumers. FDA is aggressively soliciting reasons to ban e-cigarette flavors and there are several hints that they intend to take this step. Buried in the middle of a nondescript paragraph is the observation that they would gain the authority to impose whatever unspecified restrictions on additives and constituents they want. Reading between the lines indicates they would be inclined to ban any product variation that appears to be slightly higher risk than an alternative (but still very low risk compared to smoking), regardless of whether consumers preferred it.


FDA consistently insists that e-cigarettes and other smoke-free products cannot be considered smoking cessation aids and asserts (contrary to overwhelming evidence) that they are not effective as such. Yet this regulation says that the only reason for allowing a new (which means post-2007) product onto the market is that it is useful for smoking cessation. This might just be the self-contraction that unrealistic rhetoric often leads to, but it might signal an intention to ban most everything.


3. The rules would eliminate the small businesses that provide the high-quality e-cigarette products that experienced vapers prefer.


The filing requirements that would be imposed on manufacturers would put small-sized, and probably medium-sized, companies out of business. Only a half dozen large manufacturers (particularly including the major traditional tobacco companies and their suppliers) would be able to meet these requirements.  Moreover, any smaller manufacturer that was able to complete the filings would face the prospect of being instantly put out of business by the FDA’s ruling as soon as the grace period (24 months) expires and FDA gets through the backlog and rules on their applications. Thus, these regulations appear to eliminate the vast majority of e-cigarette manufacturers approximately two years after they take effect.


FDA repeatedly asks for comments on how the requirements could be made non-fatal for small manufacturers. But this appears to be disingenuous; there is simply no way to reconcile the burdens imposed by proposed requirements with the resources of small and medium specialty businesses that make higher quality e-cigarette components.


4. The scientific claims made by FDA are flawed and biased.


We are very concerned with FDA’s apparently tenuous grasp of the relevant science.  They ignore the bulk of what is known, repeatedly misinterpret studies, and accept as fact politically-motivated assertions of authors.  They have some out-and-out factual errors in their review of the science, but far worse is the spin and innuendo. They cherry-pick single sources with particular conclusions about topics that are far more uncertain when all the evidence is considered.  In almost every case, the uncritical acceptance of bad information tends to justify restrictions and deny the harms they will inflict on the public with these restrictions.  This bodes ill for what they will accept as new evidence in response to their requested comments.  


By contrast, they downplay overwhelmingly obvious facts about the benefits of e-cigarettes.  For example, they present the statement that e-cigarettes reduce exposures to toxicants compared to smoking, something that is true beyond a doubt, with the caveats “some researchers have stated” and “may.” They similarly downplay the evidence about e-cigarettes’ effectiveness in aiding smoking cessation.


(We expect to provide more details about the scientific errors and spin at the antiTHRlies.com blog over the coming weeks.)


It is this biased view of the science that will presumably be used to evaluate product applications, determine the content of warning labels, and otherwise control communication. In particular, FDA implies that a new tobacco product can only be justified if it is effective for harm reduction (a term they blatantly avoid). Yet FDA’s evaluation of e-cigarettes seems to deny they are effective. Given that the harm reduction potential of e-cigarettes is supported by about as much evidence as is imaginable for any new product, It is difficult to see how they could reach a favorable ruling about any product.


FDA asks for comments about many aspects of the proposed regulation, including evidentiary support. They do not do this for most of their tenuous scientific assertions, however. Furthermore, they demonstrate a willingness to accept most anything as evidence if it supports their inclinations. Since they will inevitably get comments from someone providing ostensible evidence to support every claim they want to make, and since they demonstrate a tendency to cherry-pick and uncritically report such claims, this suggests that FDA will conclude that they have adequate support for every additional restriction they wish to impose.

Taking Action.

It is our current assessment that these proposed regulations are not in the best interests of consumers. They include some good provisions, but do far more harm than good. They are based on arbitrary claims and rationalizations. Should the regulations be finalized as currently formulated and implied, we are prepared to marshal our resources to file a lawsuit on behalf of consumers.


We expect to provide further analysis on Monday, April 28th, 2014. In the next week or two, we will issue a Call to Action detailing how the proposed regulations affect consumers along with suggested actions so that consumers can respond most effectively. Please remember that a comment to the FDA regulations made on Day 1 is given no more weight than a comment made on Day 75.  We urge the vaping community and others interested in opposing regulation that discourages tobacco harm reduction to await further analysis before acting. There is no benefit in acting or opining precipitously.

53 comments:

Thomas Pavlou said...

We stand together and we will fight together! You have my 100% support! I will also donate what I can for legal challenge and hope others will do the same! Thanks for this interpretation!

Matthew Newcomb said...

I am carefully considering all the information and will await your further analysis wile reading the entire regulation, as such I will be formulating a comment that will be submitted on day 73 or 74 but not before, I want to have as much information as possible in my comment as I can before i make it

Tom McCormick said...

United We Stand, await further ananlysis, then take action!

Brandon Fireking said...

I've never been any good at writing up comments or letters, if anyone can help me out with it so I can start compiling SOMETHING to send to the FDA, please contact me, I'm using my google account to post this, so that should be sufficient

Scott McKirahan said...

This doesn't just affect the USA. Other countries rules are directly tied to what the FDA does. Additionally, because the USA is such a large market, changes that are made because of these regulations will effect the e cigarette industry worldwide.

Unlike other calls to action that are extremely regional or statewide, this is one that every single website marketing these goods, reviewing them or talking about them needs to have in the banner at the top of every single page. I, for one, will be putting that banner in the header of my websites, linking to your call to action, urging all readers and consumers to take action for their own benefit.

TBD said...

I appreciate your hard work in reviewing the deeming regulations so quickly. We will work to organize and inform each other so that we are ready to provide input when the issues become clear.

Tiffanie Howe said...

Thanks guys.

david vandermallie said...

FDA is now know as the fucking dicks administration ....

Peyote skye said...

thank you for being willing to fight for our rights against this. i will wait and see what you all say.

Todrick said...

Thank You!

Nice Summary.

Sandy's World said...

United We Stand !!! The government just wants their greety little hands in it because of the cut in tobacco sales.....SCREW THE FDA !!!

David Holmes said...

This is about money again, in the new America, it's only about money. I will not obey any laws designed to kill me. I will find or create a black market. FDA reg's is mass murder for profit. I will not comply with criminal activity.

Cassius Cloud said...

We will become too big to fail,they'll see!

Charles Greene said...

As a trooper in the vaping militia I applaud your help and information . any financial help/donation I can manage I will. As my slogan says "JOIN THE FIGHT or LOSE THE RIGHT "

Dominador Pinera said...

If a small eliquid manufacturer is one month away from the launch of their product, what should they do? Is it even worth it to go ahead? Or should they just stop production and cut losses?

Art in Weedot Style by Karrie A. Lyons-Munkittrick said...

#KeepTheVape

John H. said...

Great post, Julie! It confirms a lot of my thoughts as I read through the proposed rules, and gives me a few more to think about. We appreciate everything CASAA does, and await information on how we can help! Keep up the good work!

John H. said...

It's up to your situation, but my opinion as someone with no stake in your business is "Go for it!" This will be open for comment through July, then any revisions will need to be published, possibly with a new comment period opened. Don't let the possibility of government meddling destroy innovation.

Rwoodin said...

Don't forget to fight the FDA with your VOTE. FDA would not be able to impose regualtions on everything if it were not for a Government mandate that it do so. Let's hope that elections can help put the people in office that are ready to cut the FDA back down to size.

Carl Criss said...

Do all you can while you can I'm going ahead with my plans to make mod stands and do patina and custom finishing on mods I can get or as a service to vapors less inclined to put in the work but want the look
I refuse to let the Gov, FDA and corporate America kill the American Dream

Rain Man said...

Excellent analysis. I'm prepared for donations to a legal effort. Enough is enough, this will not stand.

Russell Wilkerson said...

All this time in regulating a harm reduction device, yet the more harmful cigarette still available at every corner store

Labrat Vapes said...

I hope people understand how serious fighting this is.

Keith Hoyle said...

In studying your above assessment, I am more sure than ever that my theory is correct; the stage is being set for the elimination of second and third generation vaporizers so that big tobacco can monopolize the market with their cig-a-likes. Final proof that the FDA is owned not only by big pharma but also big tobacco. I see a lengthy legal battle in our future, and you can count me in as a warrior.

David Cocina said...

I for one do NOT want to go back to analog smokes! I have been taking all the action I could in past proposals. I am ready to step it up. Please join me and do all that CASSA advises for actions and anything else you can think of. You MUST also contact friends and family to join you. We need the non-eig/smokers to also be heard in support of the e-cig/vapor users.
These FDA proposals will do nothing but push control and money back to the HUGE cigarette companies that got us hooked on nicotine in the first place. We CANNOT let this happen.
Thank you CASSA for all your hard work.

havanowoncheese said...

Sounds good. I await the call to action patiently.

dave jones said...

we stand united and will support as needed, vape on

Powerof Paranoia said...
This comment has been removed by the author.
Powerof Paranoia said...
This comment has been removed by the author.
Powerof Paranoia said...

I made a comment without reading the post in full.

Removed so that I wouldn't seem unintelligent. lol.

Thanks so much for the work you guys do!

Lisa Baker said...

#KEEPVAPINGALIVE

Beebopnjazz said...

I'm anxiously awaiting your further review. I will say, as the FDA wants to cover e-cigs under the TCA - I've been re-reading it - I guarantee you a flavor ban hammer is on it's way.

Dante's Inferno said...

You were told how bad this situation would become months ago, and yet you did nothing to aggressively combat this situation. When other ecig users suggested that you become more aggressive by using the mainstream media to attack the FDA and their publicized studies, you called us crazy on your Face Book page, and suggested that we were working for anti- tobacco and anti- ecig groups. But now you come to the table telling ecig users that you're going to take action if these regulations go into effect? Too little, too late. You had the opportunity months ago to start an aggressive campaign. Now that the FDA has the high ground trying to stop their regulations will render the same results as trying to ice skate uphill. If anything, these regulations are a direct result of the CASAA board members leadership inability to proactively fight the FDA in a public forum.

T Turner said...

Well said, I agree.

Spike Timmons said...

Sorry but if you haven't noticed folks but the main stream has been, is and will continue to miss inform the public. And demonize e-cigs. They are owned by the same people(money changers) who own the tobacco co's. So the main stream media is not going to help. Just like Connie Chung they will get fired if they tell the truth. Better wake up people they won't listen. And you will have to fight eventually so get prepared for it. And I'm not talking about keyboad/paper work fight either. How many more infringements upon our rights are we going to let our EMPLOYEE'S have before enough is enough.
"We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness.--That to secure these rights, Governments are instituted among Men, deriving their just powers from the consent of the governed, --That whenever any Form of Government becomes destructive of these ends, it is the Right of the People to alter or to abolish it, and to institute new Government, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their Safety and Happiness. Prudence, indeed, will dictate that Governments long established should not be changed for light and transient causes; and accordingly all experience hath shewn, that mankind are more disposed to suffer, while evils are sufferable, than to right themselves by abolishing the forms to which they are accustomed. But when a long train of abuses and usurpations, pursuing invariably the same Object evinces a design to reduce them under absolute Despotism, it is their right, it is their duty, to throw off such Government, and to provide new Guards for their future security.--Such has been the patient sufferance of these Colonies; and such is now the necessity which constrains them to alter their former Systems of Government. The history of the present King of Great Britain is a history of repeated injuries and usurpations, all having in direct object the establishment of an absolute Tyranny over these States. To prove this, let Facts be submitted to a candid world."

shoequeenvapes said...

I eagerly await the suggested actions and have blogged on the proposed ruling. Together we can curtail the FDA's madness and make a difference in how this plays out. Vape On and Fight!

Richard Bennett said...

Thank You!!

Michael said...

Aside from the fact that a media campaign is outside of the budgetary constraints of CASAA as an organization, we would stand by our policy that given the history, directly interfacing with the FDA prior to this is (and was) the proper route to take. Our decisions were made based on the years experience we've had on this issue, years more than any other organization.

An attempt to attack the FDA in the media sooner than this week would have been ignored by the press and not even noticed by FDA. It was not a media campaign that we could have won. However, CASAA leadership would never have called anyone "crazy" on our Facebook page nor accused them of "working for anti- tobacco and anti- ecig groups" for suggesting a media campaign.

That's not to say that PR would not be an effective tool now that we have actual proposed rules to address. We will continue to pursue all of the several types of actions that we believe are useful. However, we will not waste resources on feel-good actions that offer no hope of real accomplishment.

If you'd like to blame CASAA, we've got big shoulders and can handle that. But it's important to point out that CASAA and other organizations did in fact present directly to the FDA. The case was made to them through both data and persuasion- apparently to little effect.

It's better to blame the FDA. And we would differ on the opinion that a massive media campaign would have netted any different outcome.

We stand by the decisions we have made as being in the best interest of consumers of reduced harm alternatives.

B Marth said...

I'll refrain from making a comment until the analysis is posted on monday. That being said I feel for a true effect to take place it may have to happen in a courtroom, sadly.

jeremy harting said...

Fda just wants money and this is the excuse these are helping people quit smoking all the ingredients are in everyday food and drinks.

SubGothius said...

The exemption for "accessories of a proposed deemed tobacco product" seems promising. From what I can tell, that may mean hardware could only potentially be subject to regulation *if and only if* it's provided with nic juice, and even then only the parts inseparably provided together with the nic juice itself may be subject -- e.g., prefilled cartos and all parts thereof might be subject, but not batteries, mods, atomizers, empty cartos/tanks, etc.; this would be analogous to cigarette papers, filters, and snus satchets' "teabag" material being subject, but not lighters, lighter fluid, RYO machines, ashtrays, etc.

However, it's unclear whether even separable hardware accessories could still be subject to regulation if they're provided together with a nic juice supply (e.g., in starter kits or disposables). In that case, I wonder if formalizing a blanket hardware definition of current technology would be sufficient to establish substantial equivalence among all current devices, effectively grandfathering all current technology by default -- e.g., the final rules could state something like this:

"Electronic cigarettes and personal vaporizers ('e-cigs/PVs') shall be understood to consist of devices that employ electricity to energize a heating element, to which a liquid preparation containing nicotine is applied, which in turn boils into a vapor which the user inhales. All devices which operate on this fundamental principle shall be regarded as substantially equivalent and thus implicitly compliant with FDA regulations by default without specific FDA review or approval prior to retail sale and distribution."

A similar provision for nic juice may be sufficient to formalize and grandfather everything we currently know and (perhaps naively) take for granted about reputably-produced e-liquid, so only significant deviations from this industry-standard formula would need formal review and approval -- e.g.:

"Liquid preparations containing nicotine distributed via retail channels to be vaporized by e-cigs/PVs ('e-liquid') must consist solely of USP-grade propylene glycol, glycerin, and/or polyethelene glycol 400, optionally diluted with deionized water, as a carrier agent for pharmaceutical-grade nicotine at >0 to ≤36 mg/ml concentration to be clearly labeled on the e-liquid container or other packaging, and optional flavorings which the FDA classifies as GRAS (generally recognized as safe) or has otherwise approved for human consumption in foods, beverages, or dietary supplements, excluding any such flavorings already linked by medical evidence to significant deleterious health effects when inhaled (e.g., diacetyl)."

This "formalize the known" approach would counter the "we don't know what's in e-cigs/vapor" arguments from ignorance and preempt unnecessary and burdensome regulatory overreach derived therefrom, which would also greatly lighten the FDA's regulatory burden in reviewing devices and nic juices for approval. Furthermore, by grandfathering the whole class of current devices and juices as compliant by default without formal review/approval, the burden would be on industry producers and vendors to maintain compliance subject to substantial fines or other penalties in the event that any noncompliant deviation from these standards may be discovered.

Deak D said...

Willing to donate to file a legal challenge.......

Stéphane Lévesque said...

For me ejuice should be regulated; only at some degrees. When i buy some i would like it be have an ingredient list - allergen listing - warnings - childproff caps. And finally a seal so i know no one tampered it between the makers and the reseller. The nicotine is added by request from the customer, like adding salt or sugar to a coffee; so for me labelling it a "tobecco" product just because of that, is stupidity. If i do a recipe of a nice drink and add caffeine then it's a coffee? im sure Coke/Pepsi agree..?

Point 3 is probably the biggest thing and when reading what you wrote it is totally subjective and won't be taken in consideration seriously. The third point is what gonna kill ecig. In this industry, what made thing progress so quickly is the innovation and creation put forth from makers all around the word and groups. They raised the standard very high and china cloning market is forced to follow. In the end the customer gain direct benefit for that - safer batterie - safer regulated device - safer atomiser; built to last. For me the hardware used should be regulated except to state what "could" affect what you inhale. So for me, except stating that the deck of a rda is in SS 306L chirugical grade and doesn't release bad chemical when heating, the rest of the device - the system it use/number of poles/how big the pole/hole are - is no one business except for the customer and his personal "ideal way" to vape; as it doesn't affect what's inside he is inhaling.

Stéphane Lévesque said...

..."For me the hardware used should "NOT" be regulated except to state what "could" affect what you inhale"...

Paul LaFaver said...

That was helpful.

Mickelodian said...

Personally I agree Scott and I think to be honest EU and US vaping vendors, customers and forums need to regroup and organise a trip to the courts in every nation. This nonsense might work in the wild but not in a courtroom where statements need to be backed up with witnesses, evidence and studies. In fact the sooner we can get this nonsense into a courtroom the better... because it cannot stand on its own. But whats needed is for vendors to help too.... Now I have an idea or two there on how that can work... but obviously not on an open forum.

Paul LaFaver said...

CASAA is doing yeoman's work and deserves everyone's support. Having said that, I fear that there is, in fact, nothing that will stop the Federal government from doing what it wants. I am in the Vapor business so I am not without skin in this game. This Administration has demonstrated absolute contempt for the rule of law and representative democracy. Unfortunately, the electronic cigarette community, like all other specific interest groups, is comprised of many who have supported a large government model. Individual groups are only reacting when a liberty that they enjoy is threatened by the size and scope of the government. But only the symptom of the problem is being addressed, and in my humble opinion, far too late . All over this country groups such as ours are experiencing the loss of freedoms that have been taken for granted for years. Low information voters, apathy and single issue voting have contributed to a Federal government rife with corruption. Conservatives who in the past could be relied upon to resist the overreach of government have all but vanished. Liberals who historically supported individual freedom have been swallowed by a Democrat party without a soul. At this point I fear we are battling Godzilla with flyswatters. It will take decades to pare down our current colossus Federal government. It will get worse before things turn around. But we can start now by shelving our traditional political ideologies and sending representatives to Washington that truly support smaller government. There are no free lunches. Those pet programs from the government that many have become addicted to must be sacrificed. Do we have the courage and will to make the changes needed to save this great nation? Only time will tell.

Genna Marie said...

This article brings up MANY good points that were difficult to suss out in such a cumbersome document. Thank you for your excellent analysis!

Anonymous said...

The tone and wording of this proposal is meant to be Damning and Unreasonable. You can not "Reason" with these zealots. All that can be done is convince every congress person we can that voting for this will mean political suicide. It can't just be just vapers, it has to be EVERY vaper and everyone of there loved ones. That is the ONLY way to even have a small chance.

Mardee said...

I agree Paul, Thanks David for that very informative bit of information that you have the mentality of a 10 year old.

Coleen Badeaux said...

Sorry to bounce off your comment Thomas but I didn't want to go all the way down, lol

I saw it say about filing of all the paperwork would just cause confusion in safety and contamination not to mention with the care they already take in preparing the e liquid it already takes weeks to receive the juices. At the FDA's rate I'll be vaping my liquid soap! Now, how's that safe???? (that's a joke, not but really they are already very careful...all companies take forever getting the e liquids out to the consumer).

Jae Michael said...

I absolutely agree with you. When I first heard of big tobacco buying e-cig companies, the intent was clear. They are now not making the huge profits from tobacco sales. Taking over e-cigs just pads their profit margin. Clearly the FDA lobbyists are working overtime. Count me in as a warrior also.

Melissa Wallace said...

Here is my question- how can the FDA impose regulations on no nicotine flavored liquids? Would these still be considered smokeless tobacco products? Eventhough there is no nicotine?