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CASAA Blasts The FDA In Their Comments On Proposed Regulations

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FDA Gets Failing GradeLate Friday, the CASAA published the comments they sent to the FDA regarding the proposed deeming regulations on electronic cigarettes and other tobacco products.

Because the CASAA concentrates on alternatives to smoking and harm reduction, they did little to address the aspects of the proposed regulations that specifically address combustible tobacco products. They did, however, highlight several provisions of the proposed regulations that gave premium cigars, which are far more harmful than electronic cigarettes, special exemptions.

Although the general tone of the 53 page comment that the CASAA submitted is cordial, it most certainly bashed almost every aspect of the FDA's proposed regulations. Everything from the FDA's biased, cherry-picked science to their faulty rationale to their carefully spun wording to their political motivations were addressed and none in a positive light. Short of accusing the FDA of being bribed, the CASAA definitely tore the FDA's proposed regulations to shreds. I'd best describe the lengthy document as "respectfully denigrating."

Based on the relatively few people who took the time to submit their own comments to the FDA, I can only imagine the number of people who will sit still long enough to read the entire comment the CASAA submitted will also be quite a small number (it's more than an hour long read). I maintain that a substantially smaller set will comprehend everything the CASAA points out in its politely scathing diatribe (I humbly admit that a few things were over my head).

With that in mind, I'll try to condense the CASAA's comment into something a bit more bite-sized with the hopes that a few more people may take the time to read a highly condensed version of it:

Let Legislators Write New Laws Specifically For E-Cigarettes

Really, if you want to skip everything else, the CASAA's main recommendation to the FDA is to let legislators handle this issue and write new laws that specifically address electronic cigarettes. Trying to lump e-cigarettes in with tobacco products and the Tobacco Act is lazy and irresponsible since the Act was not originally written with electronic cigarettes in mind.

Although, in an effort to prevent the FDA from regulating e-cigarettes as pharmaceutical products, Judge Leon said the FDA could regulate electronic cigarettes like tobacco products, it does not mean they should be regulated in the same way. The FDA's principle role is to do what is best for public health and treating an alternative to tobacco smoking with the same set of rules imposed on far more harmful products is counter to the best interests of the public.

Short of assigning the regulation of electronic cigarettes to the only people who are legally able to make laws (i.e. the House and the Senate), electronic cigarettes need to be removed from these deeming regulations since they are based on a law (The Family Smoking and Prevention Act) that was intended for combustible tobacco products and not e-cigarettes.

A World With Nothing But Cig-Alikes

When the FDA's proposed deeming regulations were first made public, I immediately stated that the regulations would most certainly wipe out virtually every electronic cigarette, e-cig battery, atomizer, cartomizer, clearomizer and e-liquid on the market today. I alluded to it in my article, " E-Cigs & The FDA - Beware Of Fuzzy Math!" and followed that up with the article, "The Future of E-Cigarettes - Nothing But Cig-alikes According to Panel of Experts."

As is so often the case when anyone has the guts to state an opinion, I was denigrated on various forums and social networks as being "alarmist." I can't help but smile sadly to myself now; the CASAA states on numerous occasions in their comment to the FDA that the only thing left will be cig-alikes. 

Specifically, the CASAA states that the proposed regulations create a de facto ban on the vast majority of e-cigarette products that are available today and preferred by experienced consumers. "The only products that stand any chance of successfully navigating the premarket tobacco application (PMTA) process will be the cigarette-like (“cigalike") products produced by a few large companies that are better suited to dual use than a complete transition away from smoking."

In fact, they use the FDA's own words, stating, "In its economic impact statement, which predicts how many e-cigarette products will be submitted for approval, FDA concedes that the proposed regulation would preclude approval for more than 99.9% of the products currently available."

Their comment goes on to point out how the FDA violates the principles of the Paperwork Reduction Act and that the onerous paperwork will only allow the major tobacco cigarette companies to compete in the e-cigarette world.

Because tobacco companies are perfectly content to only offer sub-par cig-alike products to compete with the real cigarettes they produce, there will be no innovation by the tobacco companies and nobody else will be able to afford the paperwork, alone, not to mention the scientific requirements innovative products must provide before being introduced into the marketplace. 

Worse, it appears that the paperwork requirements were created for no other reason than to place an impossible burden on the vast majority of e-cigarette companies. There is nothing in the paperwork that addresses health, quality control or safety issues. Once again, this seems to be something that was created as a means of letting Big Tobacco survive and squash everyone else.

Hello Black Market!

Instead of creating the idyllic world the FDA envisions where only approved products that are strictly regulated will exist, the exact opposite will occur. "There will be a vibrant black and shadow market," says the CASAA.

According to the CASAA, this will happen because of the absurd amount of time (2+ years) it takes for anything to get approved. Once approved, those products will already be far behind the curve of what is being developed outside of the FDA's regulatory realm and will undoubtedly be far more expensive because of the costs associated with the approval process.

The CASAA points out that the FDA incorrectly believes that supply dictates demand and not the other way around. They say that the demand will not "magically disappear when the FDA asserts jurisdiction over the supply."

And, of course, only a government organization could be naive enough to think that laws that do not punish citizens for using unapproved products is going to keep them from using them. The federal government is hardly winning the war on drugs, which DO carry fines and imprisonment for consumer use. Heck, even states are thumbing their nose at the federal government and passing laws that legalize marijuana! How they think consumers aren't going to use whatever they want to when there is no penalty for using those products is beyond rational thinking. (Please note: this paragraph is my own opinion and not part of what the CASAA submitted in their own comment.)

Not only will the electronic cigarette black market thrive under FDA regulation, the exact opposite of the FDA's stated goals will be accomplished. Instead of creating an environment where innovation and public health improvements are rewarded, a system will be established where very little of what is being used is regulated.

Those politicians who believe that this will open the door for a new product to be taxed are seriously misleading themselves and the public. Not only will the black market create a product line that will avoid excise taxes, the proposed regulations will shut down virtually all businesses that sell electronic cigarettes, both online and brick and mortar, which will eliminate all sales taxes that states have been reaping from these products. That's more than $50 million in lost sales tax revenue nationwide. (Please note: this paragraph is my own opinion and not part of what the CASAA submitted in their own comment.)

The Proposed Regulations Accomplish Nothing

The CASAA is correct in pointing out that the FDA has been very unclear about what the goals of these regulations really are. The net effect is that it will harm public health, so that certainly can't be one of the FDA's goals.

If their goal is to decrease availability to minors, the proposed regulations really do nothing to address that. The cheap, small, easy to conceal cig-alikes seem to still be winding up in their hands even though most states have banned the selling of e-cigarettes to minors, so making those the only e-cigarettes available accomplishes nothing. The FDA hints in the document that a flavor ban may be imminent (which the CASAA points out is political fodder) but, because of a thriving black market, flavors will still be widely available and completely unregulated.

The CASAA points out that nothing in the regulations is geared toward creating a better-informed public. The only misinformation pertaining to e-cigarettes is being put forth by those who oppose them. They also correctly point out that the FDA is not trusted by the electronic cigarette community, so even if they plan to inform the public about e-cigarette issues, nobody is going to believe them.

Warning labels that they have proposed will do nothing to better inform the public. In fact, putting statements about addictiveness are premature because there has never been a study that showed that e-cigarettes are addictive. Placing the same label that is on smokeless tobacco packages - "not a safe alternative to cigarettes" - will be just as erroneous as the labels on those smokeless tobacco products are. Anyone who says that smokeless tobacco or electronic cigarettes are just as harmful as tobacco cigarettes is flat out lying!

The CASAA addresses the myth about the "gateway effect," stating no credible study has ever shown a correlation between e-cigarette use leading to tobacco cigarette use and that even if there was such a thing, the regulations do nothing to prevent it.

Most important, the regulations do absolutely nothing to reduce contaminants that may be present in e-liquid or address certain flavors being more hazardous than others. Not only is there no quality control measure in the regulations but by driving the bulk of consumers to the black market, even if they were to include a provision for testing sometime down the road, it would accomplish very little.

The CASAA points out several other things the regulations do not accomplish but sums it up by stating that the only purpose of the regulations seem to be to expand the power to regulate.

The Regulations Are Discriminatory

One section of the CASAA's comments that was particularly enlightening was the small portion they devoted to premium cigars. Although they took a step back and said that, because they represent alternatives to smoking, they would not advise on policies regarding combustible products such as cigars, the CASAA was very good at pointing out how the FDA's proposed regulations discriminated against the poor and favored the wealthy.

Conspicuously, the FDA's regulations look the other way where premium cigars are concerned. This is because that industry is one that caters to people that most consider to be quite wealthy and they have politicians who have lobbied quite hard to exempt expensive cigars from the rules all other tobacco products are forced to adhere to under the Tobacco Act. 

This is absurd because premium cigars certainly have far more cancer concerns than electronic cigarettes do. The FDA justifies excluding premium cigars for the same reasons that electronic cigarettes could just as easily be excluded from the rules:

  • The high cost of premium cigars is actually less than what decent electronic cigarette components cost but is used to point out that adolescents couldn't afford those higher priced cigars. Of course, it is these very same higher end e-cigarettes that will be removed from the market by the proposed regulations.
  • The FDA says premium cigars pose a lower health risk than cheaper combustible tobacco products because they will not be used as often and will not be a product that someone initiates tobacco smoking with. Clearly, electronic cigarettes pose a lower health risk compared to combustible tobacco and, despite totally unfounded fears, no study has ever shown that people are using e-cigarettes as a "gateway" device to tobacco cigarettes. (I'll insert my own comment here, which is that I am not aware of any study that has shown that premium cigars do not lead to smoking other tobacco products).

The Public Has No Voice

As the CASAA points out, it has been generally accepted policy for decades that the general public would have "a seat at the table" when any FDA decisions are made. I'm sure the FDA will argue that the public comment period satisfies that requirement but that is hardly the same thing as being represented BEFORE any words regarding regulation are put on paper.

Instead of allowing a true consumer advocate, such as the CASAA, the FDA has filled that seat at the table with "players" that do not use the products and who, instead, have advocated for the removal of e-cigarettes from the market until more is known about them (a " chicken or the egg" dilemma if there ever was one). Those "advocates of public health" have their own interests at heart and not the consumer's.

The CASAA points out several times how very little the FDA seems to really know about e-cigarettes. They don't seem to understand how they are used, the differences between the many devices and components or even that everybody uses them differently. If true consumer advocates had been present during the writing of the proposal, they could have corrected much of the information that frankly makes the FDA look completely ignorant.

Not allowing the consumer who uses the product to have a real voice in FDA regulation is not only unheard of in modern times, it goes against everything the Obama administration supposedly stood for in terms of transparency. (Note: This sentence is my opinion and not one stated by the CASAA.)

The Science is Misleading, Flawed and False

My headline for this section was really quite kind. What the CASAA really says is that the FDA scientific analysis in the draft regulations is "biased, naive, inaccurate, arbitrary, and capricious."

A great deal of the CASAA's comment to the FDA is devoted to pointing out the bad science that the FDA cited in their proposed regulations. The document not only shoots down all of the studies cited, but it admonishes the FDA for purposefully wording things in such a way as to imply things that the studies did not necessarily conclude.

The FDA is called out for being blatantly biased and cherry picking pieces of data that, by themselves support a position that may lead some to believe that electronic cigarettes are not a viable smoking alternative, but when looked at in a study's entirety and alongside other studies that say just the opposite, do not lead to reasonable conclusions on which to base regulations.

According to the CASAA, the FDA also has completely ignored very credible studies that they definitely know about but have omitted from the discussion because those studies do not support their clearly biased view of e-cigarettes. 

It is this section of the CASAA's letter that points out how deceptive the FDA has been in their role of pretending to protect the public while really supporting a totally different agenda - one that many could easily conclude is driven solely by political and/or monetary objectives.


Sadly, I feel I will be wasting my breath (or, in this case, a few cells off of my fingertips) by telling people to read the CASAA comments to the FDA. I'll do it anyway, though. I barely scratched the surface of the entire document and my "brief" summary is already longer than many people would ever take the time to read.

Throughout the document, the FDA is labeled as being biased, naive, inaccurate, arbitrary and capricious. I can think of quite a few other words I'd use that are not fit to print!

There is a section that discusses how the FDA is contemplating future elimination of flavored e-cigarettes and how that will only increase regular tobacco usage and another that takes on the absurdity of the gateway effect argument. 

Then there's the stuff that I did not completely understand (maybe you will). There's a whole section on the gross misrepresentations the FDA makes on economic impact analysis that was, quite frankly, WAY over my head as well as another section that dealt with health impact analyses which, once again, left me scratching my head and feeling a bit like Joey Tribbiani.

The CASAA comments are an extremely enjoyable read if you appreciate a governmental agency being lambasted for being ignorant, reckless, inefficient and in all reality, highly corrupt. Sentence after sentence points out how truly absurd virtually every aspect of their proposed regulations are. Practically every point had me thinking "Who paid for this inclusion in the proposed regulations?"

More than anything, what I'd really like is for everybody to forward the comments to their state representatives in both the House and the Senate. Perhaps pummeling every news organization with the letter the CASAA wrote until a few news organizations pick up on it would be in order, too.

I also think the CASAA comments do more than enough to point out why a congressional investigation absolutely must be done to scrutinize the blatantly negligent behavior of the FDA. Of course, many of the congressmen who would be involved in such an investigation hardly have clean hands here, either. If this doesn't have corruption written all over it, nothing does. Calls for an investigation to your representatives and, again, the news agencies might have some effect on getting politicians and governmental organizations to act on behalf of public health and not on behalf of the largest contributors to their coffers.

BeatNic Blog Quote of the Day: "No man is good enough to govern another man without the other's consent." - Abraham Lincoln

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