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Senate Committee Leader Questions FDA Rules

8 days after the official release of the FDA deeming regulations, (of electronic cigarettes/vaping devices/Electronic Nicotine Delivery Systems,) Sen. Ron Johnson (R-Wis.), chairman of the Senate Homeland Security and Governmental Affairs Committee, sent a letter to FDA Commissioner Robert M Califf MD, asking a couple of simple, yet extremely important, questions.

We are going to take a couple of minutes to quickly glance over the letter and see if this can hurt, or help, the vaping communities fight against the regulatory tidal wave we are about to be hit with.

We hope you enjoy this one, just make sure you read it all the way through.

The Letter

We are going to put the whole thing in print, even though we are going to focus in on a couple of extremely important points.  That way, nothing can get lost in context and no one can be accused of cherry picking information.  If it is underlined, it’s important.

Dear Dr. Califf:

The Committee on Homeland Security and Governmental Affairs is examining the regulatory 
burdens that federal agencies place on small businesses.  
On May 5, 2016, the U.S. Food and Drug Administration (FDA) finalized a new regulation 
that expanded its authority over electronic cigarettes, commonly 
known as “e-cigarettes.” I write to request your assistance in understanding the 
consequences that this new regulation may have on small businesses and the public’s health. 

According to the FDA, the final rule extends “the Agency's ‘tobacco product’ authorities 
in the [Federal Food, Drug, and Cosmetic Act],” as amended by the Family Smoking 
Prevention and Tobacco Control Act, to include other products such as e-cigarettes.
The new rule prohibits the sale of e-cigarettes to people under the age of 18.

The regulations also require e-cigarette manufacturers to submit pre-market applications 
to the FDA in order to obtain federal approval for their products.  
According to recent reports, the new requirements would force e-cigarette companies 
to complete a burdensome and costly application process.  Some manufacturers could spend 
more than 5,000 hours to complete an application, with a minimum cost of $330,000 
per e-cigarette product, according to some estimates.  As a result of these expensive 
and time-consuming applications, many e-cigarette manufacturers—most of which are 
reportedly small businesses—could close down.

According to Christian Berkey, the Chief Executive Officer of Johnson Creek Vapor Company 
located in Hartland, Wisconsin, the FDA e-cigarette regulations would “extinguish a 
multi-billion dollar industry and put tens of thousands of people out of business.”  
Mr. Berkey also stated that the new FDA rule would have more than just a burdensome 
impact on the e-cigarette industry, the effect of the rule would be “catastrophic.”  
In its regulatory analysis, the FDA itself acknowledged that the cost of the rule 
“would be high enough to expect additional product exit, consolidation, and reduction 
in variety compared with the baseline.”

Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the 
e-cigarette industry could ultimately result in negative unintended health consequences.
The costly impact the rule will have on e-cigarette manufacturers will stifle innovation 
and make it harder for e-cigarette companies to continue to offer products that serve 
as an alternative to smoking.  It is possible that without a cost-effective alternative, 
some consumers will resort to traditional cigarettes.

In order to assist the Committee in better understanding the FDA’s decision to expand 
its authority on e-cigarettes, I ask that you please provide the following information 
and materials:

1. The final rule notes that the FDA does “not currently have sufficient data about 
e-cigarettes and similar products to fully determine what effects they have on the 
public health.”  Further, the final rule states that “comments were divided on the 
safety and toxicity of e-liquids, e-cigarettes, and the exhaled aerosol.”

A: Will the FDA issue a revised rule if there is sufficient data that finds 
that e-cigarettes are a safer alternative to traditional cigarettes?  Please explain.

B: How is the FDA’s regulation of e-cigarettes not a premature restriction on 
an industry given the FDA’s admission that it does not have “sufficient data” 
about e-cigarettes to determine the effects on the public’s health?

2. Some stakeholders claim that the FDA’s rule on e-cigarettes will stifle innovation 
and result in the closure of many small businesses that create and sell e-cigarette products.

A: Did the FDA determine how many e-cigarette businesses will be affected by the rule?

B: If not, why? If so, please provide that data.

C: Of the e-cigarette businesses that will be affected by the rule, how many of 
those businesses does the FDA predict will exit the market as a result 
of the new requirements?

3. Has the FDA considered the unintended consequences if decreased access to 
e-cigarettes leads to increased consumption of traditional cigarette and tobacco products?
Please explain. 

Please provide this material as soon as possible but no later than 5:00 p.m. on May 31, 2016.

Our Analysis

Firstly, we are thankful that Senator Johnson has taken the time to approach this matter in such a matter of fact way.

The truth of the matter is, as the majority of us know, these regulations were out of date BEFORE they were made public.  On the heels of the Public Health England and Royal College of Physician reports, how the FDA believed they could slip these regulations through without question is beyond belief.  Statement 1 B, in particular, is of vital importance.  It is asking a question that has had many on the outside scratching their heads.  How can a government agency decide it is going to regulate an industry, to all intents and purposes, out of existence, while it openly admits that it doesn’t have all the facts on the case?

The fact of the matter is that the FDA has less than 2 weeks to provide the information requested and answer these questions, adequately and truthfully, or someone at the agency could be looking at spending some time in front of a committee.

Big Vape Deals

About the author

Daniel Hall

Avid Vaper, advocate and cloud chaser. Writer for 3 vaping websites and broadcaster/presenter as Vapin Demon on Coast 2 Coast Vapers.
Originally from Manchester, England, I got bored one day and moved to the USA.
Vaping saved my life and my aim is to save as many others as I can.


Click here to post a comment

  • All I know is that as a 63 year old smoker, I could not walk up the steps unaided or across a room without being out of breath when I got there . E-cigs have allowed th o drop many meds that I took because I smoked. To celebrate I went to Go Ape and zip lined by myself and many other things I could only dream about. I have not picked up a cigarette in almost a year. I have been waiting for the big tobacco guys to get to us with the FDA.

    • Help us? They’re behind it. They’re losing money for every person that quits, and their products are the ones that will still be allowed if the FDA gets away with this. They can also afford the money to get their products tested, while most vape shops are small businesses and have 1-10 locations tops.

  • What’s sad is that before vaping, I used to think the FDA was a reputable organization. Thanks to vaping, I have learned that they are not to be trusted. What a sad world we live in where the very organization that was designed to help us stay healthy is the exact organization that’s doing the very opposite. At least I know now to never ever trust the FDA again, on anything that they oversee. So once we save vaping, it looks like the next task is to create a new organization that does what the FDA was designed to do, because they obviously cant seem to do their jobs.

  • I smoked for 42 years and I knew I was going to die because of it. I could barely tie my shoes without getting out of breath. Three years ago I discovered Vaping, quit smoking cigarettes altogether and now I am not only a healthy, happy consumer of e-cigs, but I am also a small business owner, manufacturing and selling Vape juice. I do this responsibly and with great pride. Vape has literally saved my life. It is unfathomable to me the FDA would implement a rule to not only kill my business, but in effect would hand over the industry to big tobacco and others who could afford to meet these Draconian standards to be implemented – all based on admitted insufficient evidence. I am living proof the FDA has this one dead wrong. Who will stand for Liberty? Does anyone in government even know what that word means anymore?

  • […] a letter to FDA Commissioner Robert M Califf MD, requesting information about the organizations deeming rule of the vaping industry.  Within the letter was a dead line for response of May 31, which the federal agency chose to […]



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