FDA Final Deeming Regulations Are Out – Vaping News

If you are wondering what the problem is please read this post from Mount Baker Vapor: FDA Regulation Could Kill Vaping As We Know It

Online Petitions are Starting Up: https://petitions.whitehouse.gov/petition/overturn-fdas-ruling-ecigarette-classification-tobacco-product

Full Update (Source – warning: sketchy ads on page):

Today the FDA released its long-awaited electronic cigarette deeming regulations. Sadly, the “deeming regulations” would better be called “The Cigarette Smoking Promotion Regulations of 2016.” They regulate tobacco-free and smoke-free electronic cigarettes much more stringently than real tobacco cigarettes, which the agency knows kills more than 400,000 Americans each year. And by essentially decimating the vaping industry, stifling innovation, and forcing dishonest marketing, the regulations prevent these much safer products from competing with cigarettes – the deadliest consumer product on the market.

 

I will have much to say about the regulations in the coming days, but for now, I want to outline the three major provisions of the regulations and discuss their impact on public health.

 

1. Pre-Market Tobacco Applications

 

SUMMARY
As expected, the regulations require virtually every manufacturer of a vaping device and/or e-liquid to submit a burdensome and costly premarket tobacco application (PMTA) for each of its devices and products. The FDA established a grandfather date of February 15, 2007, meaning that unless your product was already on the market in 2007, you must submit a PMTA. Although the FDA allows a pathway for products that are “substantially equivalent” (SE) to predicate products that were on the market in 2007, virtually none (if any) existing products are substantially equivalent to products on the market in 2007.

 

To demonstrate substantial equivalence, the FDA will require the manufacturer to show that the product is not only similar to the predicate product but that any differences between the products raise no “questions of public health.” Since virtually every aspect of the design of e-cigarettes and e-liquids affects its public health implications, unless a product was actually on the market in 2007, it will not be able to demonstrate substantial equivalence. This means that, as expected, the PMTA pathway will be the only available pathway for virtually every vaping product whose manufacturer wishes to stay on the market.

 

The effective date of the regulations will be approximately August 10, 2016. Manufacturers will have two years from that date to submit PMTA’s for every product (meaning every vaping device and every e-liquid) they wish to stay on the market. If the manufacturer submits a PMTA within this two-year period, it will be allowed to stay on the market for one additional year unless the FDA makes a decision on its application prior to that additional 12 months. If the application is not approved, the product must be taken off the market.

 

In addition, no new vaping products or e-liquids will be allowed on the market from August 2016 forward unless the manufacturer submits and obtains approval of a PMTA.

 

What constitutes a vaping product or e-liquid? Every different vaping device is considered a separate product and a PMTA must be submitted for each. Similarly, every different e-liquid is considered a separate product and a PMTA must be submitted for each. E-liquids with different nicotine strengths are different products. So are e-liquids with different flavors or any differences in ingredients. Thus, if you are a manufacturer that makes 20 different e-liquid flavors and each comes in three nicotine strengths, you will have to submit 60 different PMTA applications, each one demonstrating that the particular e-liquid in question, when used in a variety of different vaping devices, will be beneficial for the public’s health.

 

To demonstrate that a product is beneficial for the public’s health, the manufacturer will have to consider not only the risks and benefits to smokers but the risks and benefits to non-smokers (including youth) and former smokers. Manufacturers will have to demonstrate not only that the product is safer than cigarettes, but that it is effective for smoking cessation and its cessation benefits will not be outweighed by uptake of the product by nonsmokers, including youth.

 

IMPLICATIONS

The FDA has conservatively estimated the cost of a PMTA to be $330,000. While I think this is a gross underestimate, even if we accept this as accurate, a manufacturer of 20 e-liquid flavors with three nicotine strengths each is looking at a capital cost of $19.8 million. Quite clearly, this is a cost that only a very small number of manufacturers (the tobacco companies and the very largest of the independent manufacturers) can afford. This is why the e-cigarette industry will be devastated and thousands of companies will be forced out of business.

 

Although vape shops will not themselves have to submit PMTA’s unless they mix their own liquids, the companies that produce the products sold in vape shops are almost uniformly small manufacturers that will be forced out of business. Thus, there is no way vape shops will be able to survive. The only products remaining on the market will be those produced by the largest companies, and those are typically sold in convenience stores and drug stores rather than vape shops. Thus, these regulations are going to specifically decimate the more than 16,000 vape shop businesses, creating a significant negative economic impact and putting tens of thousands of people to the unemployment line.

 

More importantly, the severe contraction of the market will limit the growth of the overall market. I don’t see the possibility for the continued growth of this market under these circumstances and believe that the level of e-cigarette use will plateau within five years. Thus, the prediction that vaping products could produce a public health miracle – decreasing tobacco cigarette consumption by 50% in the next decade – has been extinguished by the FDA.

 

Moreover, the regulations will stifle innovation. They not only take away any incentive for innovation because of the burdensome new product application process, but they also make it literally impossible for all but the largest manufacturers to commit the resources necessary to develop and test the new products extensively enough to submit a successful new product application. The public health impact of this requirement is that it will greatly impede the development of even safer and much more effective vaping products that can help a greater proportion of smokers to quit in a way that minimizes any long-term health risks.

 

2. Modified Risk Claims

 

SUMMARY
As of the effective date of the regulations (approximately August 10, 2016), manufacturers will not be allowed to make modified risk claims. This means two things: (1) they will not be able to truthfully inform consumers that vaping is much safer than smoking; and (2) they will not be able to truthfully inform consumers that vaping does not produce smoke, that e-cigarettes do not contain tobacco, or that the levels of constituents in the e-cigarette aerosol are much lower than in tobacco smoke, or absent altogether. The FDA has specifically stated that companies cannot even describe their products as a “smoke-free” alternative to smoking.

 

While a company could apply to be allowed to make a modified risk claim, the regulations make it extremely unlikely that a successful application could be developed. To make a claim that e-cigarettes are safer than real cigarettes, one would most likely have to conduct or cite relevant human studies demonstrating long-term benefits of the product. This would be a time-consuming and cost-prohibitive process that could only be conducted by the very largest of the manufacturers.

 

To make a reduced exposure claim, such as that e-cigarettes contain lower levels of a particular carcinogen or that they are smoke-free, one would have to show that consumers will not interpret this to mean that the product is safer than cigarettes. I believe this is an impossible showing.

 

IMPLICATIONS
There are two major implications of the modified risk provisions of the regulations. First, it means that manufacturers will not be able to market their product based on the three most important benefits of the product: (1) that they can help people quit smoking; (2) that they are safer than cigarettes; and (3) that they contain no tobacco and produce no smoke. This severely hampers the ability of the companies to market their products and of course, this will reduce the potential demand for vaping products. This will also result in the protection of cigarette sales because it eliminates the most effective competitive market claims that could possibly be made to convince people to switch from tobacco cigarettes to tobacco-free vaping products.

 

Second, it will prevent companies from telling consumers the truth and will effectively force them to lie to the public. Remember that deception can occur not only from what a company says, but from what the company fails to say. By forcing companies not to tell consumers that the products are intended to help smokers get off cigarettes and to reduce the risks from smoking, the FDA is essentially forcing companies to deceive the public. For this reason, I believe this aspect of the regulations is unconstitutional as it violates the free speech rights of vaping manufacturers.

 

3. Listing of Potentially Harmful Aerosol Constituents

 

SUMMARY
Within three years of the effective date of the regulations, every company will have to submit – for every one of its products – a list of all of the potentially hazardous constituents present in the aerosol. This is itself very costly, as it requires contracting with a testing laboratory, the testing is expensive, and every single flavor or variation must be tested separately.

 

IMPLICATIONS
This aspect of the regulations – although burdensome – will not actually increase the burden of the regulations because in order to submit a successful PMTA, a company would have to present the results of chemical testing of the aerosol produced by every one of its products anyway. So this requirement is superfluous because you can’t submit a PMTA without providing this information anyway.

 

The Rest of the Story

 

Without question, the FDA has done a huge favor for the continued strength of cigarette consumption in the United States. It has blocked what would otherwise been a wonderful opportunity to develop a strong competitor to tobacco cigarettes that could have eventually eroded the cigarette market by nearly 50%, resulting in what could have been literally a public health miracle in terms of the number of lives saves and diseases and suffering averted.

Instead, the FDA basically preserves the status quo, with more than 400,000 Americans dying each year from a cause that is very much preventable.

This is a huge disaster for public health.

 

What Can Be Done
The only way out of this disaster would be for Congress to enact legislation that prevents the FDA from requiring PMTA’s for vaping products and forces the FDA instead to develop actual safety standards for these products. While the Cole amendment is a step in the right direction, it is still problematic because PMTA’s would still be required for new products. We need to encourage innovation, not stifle it. That is the only to develop safer and more effective products that will maximize the benefits while minimizing the risks associated with this much safer alternative to cigarette smoking.


Updates from Gregory Conley:


The FDA Final Deeming regulations are out. Please be patient while we all figure out what exactly is going on. Based on SFATA’s first quick read through (disclaimer) this is what we know. Obviously ,things will become clearer with a little bit of time. I am going to be updating this post as more information surfaces.

  • The grandfather date has not been changed
  • Accessories are not considered tobacco products
  • Shops that make E-Liquid are now considered Tobacco manufacturers
  • A 3 year window has been put in place for a hazardous chemical test
  • Sampling has been banned
  • There will be help for small business
  • Non-Nicotine products will be exempt
  • Use of words like smokeless and smoke-free are banned
  • (new) sales to anyone that is under 18yo is prohibited. Picture ID verification is required. Retail or Internet

Many comments also sought clarification and examples as to which objects used with e-cigarettes would be considered components, parts, and accessories. The following is a nonexhaustive list of examples of components and parts of ENDS (including e-cigarettes):

  • atomizers
  • flavors used or intended to be used with ENDS (with or without nicotine)
  • e-liquid solvents
  • tanks and tank systems
  • batteries (with or without variable voltage)
  • coils
  • cartomizers
  • digital display/lights to adjust settings
  • cartomizers
  • programmable software

The following is a nonexhaustive list of examples of objects used with e-cigarettes or other ENDS that would likely be considered accessories

  • screwdrivers
  • lanyards.

Full PDF’s of the Regulations

Deeming Regulations Full PDF: 2016-10685

Early Draft of the Regulations: industry_guide_draft_tveca

SFATA Links:

Website

Twitter

Facebook

Preparing for the Chicago/Cook County eJuice Taxes – Get your nic fix without getting screwed

As most people in Cook County and Chicago know they are imposing a crazy high amount of taxation on our eJuice products. On the bright side, the eJuice with no nicotine is NOT subject to the taxes (source: CityOfChicago Website).

Why is this good? Because with a little common sense and proper preparation you can purchase the nicotine free ejuice and add the nicotine to whatever level you want. For simplicity’s sake I am going to use examples for 10ml, 15ml, 30ml, and 120ml bottle sizes with a nicotine base of 100MG.

Getting Started:

I am going to put this disclaimer up front here.

NICOTINE IS VERY DANGEROUS AND MUST BE HANDLED WITH CARE.

BE VERY CAREFUL THAT YOU MEASURE OUT THE CORRECT AMOUNT WHEN ADDING TO YOUR JUICE.

IF YOU SPILL ON YOURSELF OR ANY OTHER SURFACE WASH WITH SOAP AND WATER IMMEDIATELY.

I WILL NOT BE HELD ACCOUNTABLE IF YOU GET SICK OR KILL SOMEONE/SOMETHING/YOURSELF.

Now that is out of the way lets get started. Here is what you will need to purchase. I am putting links to my recommended vendor as their shipping times and quality are very good.

  • Unflavored nicotine base (select your VG/PG level, I prefer 50VG/50PG to not disturb my blends)
    • 1000ML Size – Best Bang for the buck – BUY
    • <1000ML Size – Good for if you can’t swing the $50/1000ML – BUY
  • Good quality nitrile gloves
    • 5 pairs – BUY (You can buy these anywhere and in larger quantities, they are usually black or blue in color)
  • Various Syringes
    • Awesome Starter Kit – BUY

Actually Mixing:

Now that you have all the supplies all you need to do is setup a CLEAN area where if you spill you can easily clean up. Keep pets and kids away from this area while you have the nicotine out and especially when it is open.

Put on your gloves. Open the nicotine/ Measure out the amount for the desired nicotine level. Inject it into the bottle and shake. That’s it. The flavor will not be altered and you will have nicotine at the desired level in your juice!

Nicotine Easy Table (For using 100MG Strength Base)

1.5MG 3MG 4.5MG 6MG 12MG 18MG
10ML 0.15ML 0.3ML 0.45ML 0.6ML 1.2ML 1.8ML
15ML 0.23ML 0.45ML 0.68ML 0.9ML 1.8ML 2.7ML
30ML 0.45ML 0.9ML 1.35ML 1.8ML 3.6ML 5.4ML
120ML 1.8ML 3.6ML 5.4ML 7.2ML 14.4ML 21.6ML

 

I hope this is helpful for you and thanks for ready! Vape safe and vape on!

Taxing of eJuice in Chicago and Cook County

As you know I vape and I have 2 small ejuice brands that I have made in a lab that a business partner of mine runs. That being said because I care about vaping and it’s positive impacts it has had directly on people’s lives that I care about I tend to follow the news on what is happening.

Currently all vape devices and liquids (ejuice) are subject to the standard sales tax rate of all other items in retail stores. Right now since Cook County and Chicago are so far in the hole financially they are trying to fill that budget gap by gouging people that vape.

Here is what they are proposing:

Cook County is proposing a $0.20/ml tax on all liquids
Chicago is proposing a $0.25/ml tax on all liquids ON TOP OF THE COOK COUNTY TAX.

This means that if you buy a bottle of juice in Chicago you will be paying $0.45/ml in taxes on top of the price of the juice and sales taxes. For example the Equinox line that I launched a few months is a 120ml bottle for $35. With those new taxes that $35 bottle just became a $89 bottle of juice. The county and city are literally making more money off the juice than my lab, the distributor, and the shops that actually put the work in to sell the juice. This is absolutely infuriating.

Taxing legislation like this is only going to push people back to cigarettes that will just end up in more health problems and deaths from tobacco use. Not to mention that this will literally put all these shops (especially the ones in Chicago) OUT OF BUSINESS. Most of these shops are run by small business owners and they have said they will not be able to keep their doors open. On top of all that you are going to have people making juice on their own and selling it on a “black market” or sorts.

What can you do to stop this? You can CALL your aldermen and representatives and tell them that YOU DO NOT SUPPORT THIS. Explain WHY you do not support this and what negative impact it will have on the community. I have included information from the CASAA website here so you can get in touch with the right people.

Please also take a moment now to send emails and make phone calls to county commissioners. We have provided contact information and talking points below.
Cook County, IL
Board of Commissioners
Dist.
Commissioner
Phone
Email
1
Richard R. Boykin
(312) 603-4566
2
Robert Steele
(312) 603-3019
3
Jerry “Iceman” Butler
(312) 603 6391
4
Stanley Moore
(312) 603-2065
5
Deborah Sims
(312) 603 6381
6
Joan Patricia Murphy
(312) 603-4216
7
Jesus G. Garcia
(312) 603-5443
8
Luis Arroyo Jr.
(312) 603-6386
9
Peter N. Silvestri
(312) 603-4393
10
Bridget Gainer
(312) 603-4210
11
John P. Daley
(312) 603-4400
12
John A. Fritchey
(312) 603-6380
13
Larry Suffredin
(312) 603-6383
14
Gregg Goslin
(312) 603-4932
15
Timothy O. Schneider
(312) 603-6388
16
Jeffrey R. Tobolski
(312) 603-6384
17
Sean M. Morrison
(312) 603-4215

 

Comma delimited email list:

 

 

SUGGESTED TALKING POINTS

 

1) Ostensibly, taxes on traditional cigarettes are intended to discourage use. However, due to the fact that e-cigarettes and other smoke-free tobacco products are estimated to be 99% less harmful than smoking, discouraging use is counter to goals of reducing smoking rates.

 

2) Other governments are taking exactly the opposite approach; Public Health England (the government public health agency) recently explicitly endorsed a policy of encouraging smokers to switch to e-cigarettes and vapor products (https://www.gov.uk/government/publications/e-cigarettes-an-evidence-update).

 

3) Sin taxes are regressive. The smoking population, those switching to vaping, is disproportionately made up of poor and low-income people. Sin taxes place unnecessary burdens on an already financially challenged group.

 

4) Imposing a tax on these products will drive consumers to shop in neighboring counties that do not have a similar tax. Concurrently, consumers will be encouraged to shop online for better deals, sending even more money out of the community. Local businesses will not be able to compete, be forced to close their doors, and jobs will be lost. This is bad for the county and will result in less revenue, not more.

 

5) It is important to note that vapor products are already subject to a general sales tax.

 

6) Taxing e-cigarettes in a manner similar to how cigarettes are taxed sends a confusing and inaccurate message to would-be adopters that these two very different products present similar risks.  The result of this message is that more people, those that otherwise would have switched to a smoke-free product, will be encouraged to continue smoking.

Sources:

http://blog.casaa.org/2015/09/chicago-il-local-alert-oppose-extra.html

http://blog.casaa.org/2015/10/cook-co-il-oppose-e-cigarette-taxes-in.html

http://www.cookcountyil.gov/2015/10/14/preckwinkle-presents-fy-2016-executive-budget-recommendation/

http://www.chicagotribune.com/news/local/politics/ct-emanuel-budget-town-halls-0825-20150824-story.html

http://www.chicagotribune.com/news/local/politics/ct-chicago-electronic-cigarette-tax-met-20150910-story.html

Dr. Crimmy’s EJuice “Lab” – Questionable Cleanliness and Other Information

Another update. Someone found the floor plan from the realtor who manages the building that Dr. Crimmy’s is in and they have a BATHROOM in their “clean room”. Mmmmm poop particles. They are in Suite 1 and you can verify that from the video and their address.

You can also see from the listing that the back of the building is the same from the “lab” photos below. You’re busted Dr. Crimmy’s.

Property Listing: http://www.brenthoffman.com/listings/l0240.html
PDF of Listing: http://www.brenthoffman.com/pdf/ThompsonBridge2100Info.pdf
PDF Mirror: https://www.timothyhoogland.com/dl/ThompsonBridge2100Info.pdf

Dr. Crimmy's Suite Floor Plan

Update from “Matty Ice” who was the one who posted the photos. He even linked to my post. Thanks!

–Original Post Start–
Today on the Chicago Vape Nation page someone shared some photos that an ex-employee posted from their “lab”. You can see the flavorings, VG, PG, bottles, mailing boxes, and even their labels in these photos (posted below). They were initially claiming that they were NOT their photos but then released a video on Facebook (Source: Kevin Lynch (Owner of Crimmy’s) ). I have also attached the video to this post and a screenshot in case they pull it down.

Crimmys Lab Video From 09/23/2015

Facebook Screenshot Admitting to the Lab Photos
Facebook Screenshot Admitting to the Lab Photos

In the photos, you can see that it is a disgusting environment that they were making ejuice in. I myself started out making it in my kitchen on sterilized tables and used standard safety precautions for myself and the ejuice. This this is just deplorable. They have said on their FB video that this was their old location and this is no longer used.

I tried to join their Facebook group, but they are banning any new people that are trying to find out more information in order to keep things quiet. This is VERY concerning as they are clearly trying to cover something up. Even if they have a new “lab” like they are claiming my guess is that due to how tired this guy in the video looks (from cleaning the “lab” all night), the fact that he looks like he has no idea how to wear the safety gear, and they never enter any of the rooms where juice is made makes me question the legitimacy of this all.

That all being said, I will never recommend Dr. Crimmys to anyone and never purchase it again. I will stick with vendors that actually make liquid in sanitary environments whether that be at their homes using common sense or in a lab. If they were OK with the previous conditions of the place it makes you wonder how bad they will let the new one get.

This post is staying up as they are currently trying to get all the photos removed from other places. I will NOT remove these as the truth needs to be heard.

Dr. Crimmy’s “Lab” Photos (Source: Reddit)

Vapers Take Action NOW! – CASAA Assessment of FDA Deeming Regulation, April 25, 2014

Yesterday the FDA regulation draft was released and it going to effectively kill the small businesses and halt innovation of the devices. This is going to kill the vaping community and it really upsets me and we need to take action. Here is a quote from the CASAA’s article on this issue that was released today. I have it up here as a mirror as their site was going up and down earlier from the traffic. The original source is here: CASAA Assessment of FDA Deeming Regulation, April 25, 2014. I took this quote from their page at 11:00AM CST on 4/25/14.
Also take a moment to watch this video that explains what exactly this means to everyone (vapers and vendors).
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 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.