The FDA’s War on Vaping – I am Disgusted – Non-IT Related

There are many reasons why I am disgusted by the current state of our government but one that is hitting me the hardest is all these new regulations on the vaping industry. Why? Because I am involved with the vaping industry and have seen many close friends quit tobacco through it successfully after other methods failed.

The new regulations that are in effect are so strict that a vape shop cannot even help customers with their devices in any way or else face steep fines. They cannot tell anyone that it is safer than smoking (despite there being actual medical studies showing it is safer than smoking). They cannot recommend flavors or proper nicotine levels to help people quit their smoking habit.

Want to see what this is doing? Just watch this video: https://www.facebook.com/MommaVape/videos/vb.1606220196312192/1743170175950526/?type=2&theater

Eliquid makers are being hit hard with PMTA filing fees for each product that will cost over $500,000 PER filing that *might* get approved. If they do not they will have to pull their products off the market and close their businesses.

Thousands of jobs are disappearing as shops, online stores, and ejuice makers are closing their doors because they have no other choice. Millions more people are going to die from Tobacco use that could have been prevented by switching to vaping.

America needs to get their head out of their asses and realize that all the “danger” that is being spread about vaping is just propaganda that the mass media and the FDA are spreading. Chicago has even managed to “find” millions of dollars to launch an all out billboard and ad campaign against vaping (see the image at the top of this post).

Why would they do this?

They take every angle to try and make this industry seem evil, including the classic “think of the children” bullshit that has been use to push through other unfair and unconstitutional legislation in the past. If you are that worried about your kids smoking or vaping then talk to them and be a better parent. It is not MY problem if you don’t know how to raise your children properly.

Big tobacco is NOT vaping. Vaping is thousands of small businesses that are trying to provide a living for themselves and provide a safer alternative to smoking. Vaping IS a safer alternative (source) to smoking. They just want to keep you hooked and dying.

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!

Dr. Crimmys Fiasco Update! – Lawsuits, Non Payment, and More Lies

On September 23rd, 2015 I put up a post about Dr. Crimmy’s lab and the pictures that leaked showing it’s horrible conditions that they were making juice in. In addition to that there was also information regarding them lying out their teeth to try and cover things up.

I am a man of principles and what they are doing goes against my principles. If you make a mistake own up to it instead of covering it up. This is why I got involved with exposing this information. I care a lot about the vaping community and companies/people like Crimmys/Kevin Lynch are toxic to it. People/companies like these only give the FDA more ammunition to ban vape products because of situations like this. Dr. Crimmy’s needs to go out of business.

Dr. Crimmys (Kevin Lynch) also did a live show on Vapers.TV with the Vapers.TV people and the Convicted Vapes people that were the ones that were making the information about the lab known. The end result of that live show was just more lies, attempted coverups, and them not keeping their stories straight.

Fast forward to today I have found out that now they have brought a lawsuit against the guy (Tony Hart) that took the photos and sent them to a friend. On top of that they are also not paying their graphics person for the artwork that he did for them. The lawsuit reference ID is 15CV-2278. I will post it once I get a better copy. The one I have is really low quality.

Anyways I am going to keep this short and sweet. Attached to this post are the Facebook messages that had the photos in them, the email between the graphics designer and Kevin Lynch, and a link to the Live Stream video recording. I am just putting this out there because I have had multiple people ask me to be their voice.

Bottom line is that Kevin Lynch and his company, Dr. Crimmys, are bad news and I would HIGHLY recommend against getting any of their products.

Vapers.TV Live Show Recording:

Facebook Messages where the Lab photos originated from:

Dr. Drimmys NDA:

Email between Kevin Lynch and the Graphics Designer:

EmailREGraphics

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
[email protected]
2
Robert Steele
(312) 603-3019
[email protected]
3
Jerry “Iceman” Butler
(312) 603 6391
[email protected]
4
Stanley Moore
(312) 603-2065
[email protected]
5
Deborah Sims
(312) 603 6381
[email protected]
6
Joan Patricia Murphy
(312) 603-4216
[email protected]
7
Jesus G. Garcia
(312) 603-5443
[email protected]
8
Luis Arroyo Jr.
(312) 603-6386
[email protected]
9
Peter N. Silvestri
(312) 603-4393
[email protected]
10
Bridget Gainer
(312) 603-4210
[email protected]
11
John P. Daley
(312) 603-4400
[email protected]
12
John A. Fritchey
(312) 603-6380
[email protected]
13
Larry Suffredin
(312) 603-6383
[email protected]
14
Gregg Goslin
(312) 603-4932
[email protected]
15
Timothy O. Schneider
(312) 603-6388
[email protected]
16
Jeffrey R. Tobolski
(312) 603-6384
[email protected]
17
Sean M. Morrison
(312) 603-4215
[email protected]

 

Comma delimited email list:

 

[email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected], [email protected]

 

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