Wednesday, May 18, 2016

Democrats applaud FDA e-cig regulations while raking in substantial funds from competing pharmaceutical companies

Companies such as Pfizer and Teva Pharmaceutical Industries make smoking cessation products like nicotine gum and patches, which directly compete with e-cigarettes to get smokers off tobacco.
Seven Democrats who signed the following congratulatory letter to the FDA have raked in substantial sums from these organizations’ PACs, lobbyists and employees:
“We commend the Food and Drug Administration (FDA) for finalizing the deeming rule that extends FDA regulatory authority to include all tobacco products, including e-cigarettes, cigars, and pipe tobacco, to protect the public’s health—and especially the health of the youngest Americans—from the harmful effects of tobacco,” the senators wrote.
If you think these regulations are not fueled by money and government corruption, have a look at these figures...
Pfizer: $12,300, 2009-2012
$24,300, 2009-2014
$28,500, 2011-2016
Total: $65,100
Pfizer: $12,000, 2005-2010
$33,250, 2007-2012
$38,250, 2009-2014
$35,750, 2011-2016
Total: $119,250
Pfizer: $45,298, 2009-2010
$76,048, 2009-2012
$72,800, 2009-2014
$44,500, 2011-2016
Total: $238,646
Teva Pharmaceutical Industries: $12,500, 2005-2010
$14,500, 2007-2012
$18,450, 2009-2014
$15,750, 2011-2016
Pfizer: $15,000
Total: $76,200
CVS Health: $55,250, 2007-2012
$43,250, 2009-2014
$39,200, 2011-2016
Total: $137,700
Pfizer: $16,000, 2009-2014
Total: $16,000
CVS Health: $20,500, 2005 -2010
$27,050, 2007-2012
$33,050, 2009-2014
$28,050, 2011-2016
Pfizer: $10,000, 2011-2016
Total: $118,650
If you object to this behavior, let your government officials know. Let your voice be heard at the polls and online. #SupportHR2058 #SupportColeBishop #SaveVaping #VapingSavesLives #QuitSmoking

Open Letter to Dr Sahar Halabi - Chicago IL

This is my open letter to Dr Sahar Halabi of Chicago Illinois in response to the following statement she made recently with the American Lung Association (ALA).

Hello Dr Halabi. 
I am writing you today because of a news article I read quoting you on the harm of electronic cigarettes.  I thought you might be interested to know that I am a former smoker of 3-packs a day, and I used e-cigs to help quit almost 3 years ago.  As a pulmonary physician, I'm sure you can realize the benefit of me no longer smoking that many traditional tobacco cigarettes.  I no longer have respiratory issues, I havent been sick in 2 years, my blood pressure and heart rate have all been lowered and I no longer have severe sleep apnea.  

I sincerely believe your statement misrepresents the benefit-risk profile of electronic cigarette use. In your statement, you are telling all smokers that the risks of trying e-cigarettes outweighs the potential benefits. But this is not at all consistent with the actual science. The science unequivocally demonstrates that there are tremendous medical benefits to patients who are able to quit or cut down substantially on smoking tobacco cigarettes using e-cigarettes. And there is essentially no harm in allowing these patients to try to quit using e-cigarettes because smokers who use e-cigarettes are precisely those who believe they are unable to quit using any other methods. 

I was one of them and as a business owner, I see hundreds of people each month who have been successful quitting smoking using e-cigarettes after failing in every other attempt.  Many of my customers, once getting off traditional tobacco cigarettes actually lower their nicotine as well.  I personally started with 24mg and now I vape 0-3mg.  This rings true to just about everyone I have met throughout this industry.  

I know you are trying to be responsible and you have your own beliefs, but as a physician, I strongly feel that your statements in this article are a complete distortion of the risk-benefit ratio for the individual patient, and it therefore constitutes negligent medical advice.  I encourage you to do more of your own research and discover the actual truth that e-cigarettes could actually save lives.  

We are not saying vaping and e-cigarettes are 100% safe, but they are better than smoking in every single way.  We can both agree, we know without a shadow of a doubt that smoking cigarettes kills.  I also agree that there needs to be more research on e-cigarettes, but right now, let’s get people to quit smoking.  Let's save a life, like they have saved mine.  

I would be happy to further this conversation over the phone or skype if you're interested.

Wednesday, May 11, 2016

FDA’s New Deeming Regulations: How Does It Affect Us?

The FDA Deeming Regulations will have little to no impact on the consumer for the next 30-90 days (until August 5, 2016).  New products will be allowed to be introduced into the market and shops can continue to sell its inventory.

However after this grace period and for up to 2 years from the publication date (May 10, 2018), manufacturers and anyone else who makes e-cigs, e-liquid, accessories and other advanced vaping products/components will need to submit a Premarket Tobacco Product Application (PMTA) for each and every SKU, variation, and nic level of products they produce.  This process is estimated to cost anywhere from $200,000 to over 1 million dollars per application.  A small juice company making 5 flavors in a line, would have to submit a minimum of 20 different applications potentially at the price tag of 20 MILLION DOLLARS!

During this time, consumers will start to see an industry freeze.  There will be a significant decline of available products, particularly e-liquids.  Shops will no longer be able to build an RDA or offer samples of liquid with nicotine.  Most small businesses will go out of business.  The rest may be subject to higher taxes, licenses, and fees.  Online sales may also be prohibited.

After 2 years and up to 3 years (May 10, 2019), manufacturers must have started the costly PMTA process and/or been approved for a product to be on the market.  Any products that have not gone through the process, or are rejected, will be prohibited to sell and manufacture as of this date.  Based on the 2007 product technology date the FDA is using (predicate date), if this ban would go into effect today, 99% of the products on the market currently will be considered illegal.  Any product not approved by this date will be off the market.

To shop owners and other small businesses, this is a HUGE win for Big Tobacco and a death blow for our industry.  In less than 2 years, the vape world as you know it will be decimated.  No longer will you be able to sample a huge variety of e-liquids, no longer will you be able to get a vaping device that works for you and helps millions of people quit smoking cigarettes every day.  Shops will close, products will disappear and the industry will be forced into an illicit black market.

As consumers and owners, we have 2 options at the moment.  We can respond through legislation or litigation.  And we need to utilize our lobbyist and advocates for both.  But there are also things we can do to help.

Our first step is to help get HR 2058 passed.  This will change the predicate date to something closer to today and will continue to allow the 99% of all products on the market after February 2007 to be sold and manufactured.  Any new products brought to market would be subject to PMTA. This is our first defense and one that would immediately right the course.  If you click THIS LINK, you can send a pre-drafted letter to your senators and congressmen in your area, or you can draft the email yourself.  It literally takes 2 minutes of time.

We could also litigate and get these regulations tied up in court for years.  We could sue saying the FDA doesn’t have the authority to regulate e-cigarettes, etc.  This is definitely an expensive option as well, but still less expensive than the PMTA fees.

There are still many questions that need to be answered and information is being sorted and understood further on a daily basis.  I encourage everyone to please do your own research as well and continue telling your story to your congressmen and senators.  As a community we have a lot of fight in us and if we stay strong, united, and respectful, we may be able to get these rules turned back into our favor.

Here are some valuable links if you would like to get involved in the fight:


CASAA.ORG FDA Deeming Regulations: Release and Next Steps


Final Deeming Rule


Proposed Rule: Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)

Additional Resources