Senator Ron Johnson’s New Letter to FDA

Senator Ron Johnson was not supposed to get re-elected if you listened to American pollsters this summer.  Infact, the entire US Senate was supposed to flip party.  Perhaps that is why the FDA snubbed his initial letter regarding the Deeming rule when he sent it in the last months of his 6 year term.

Now that he has been re-elected, and a new administration has pledged to work with Congress to repeal senseless regulations and reign in misguided and unaccountable federal agencies, his letters won’t fall on deaf ears any longer.  Here is a transcript of a new Ron Johnson letter sent to the FDA November 21, 2016:

 

The Honorable Robert M. Califf, M.D. Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993

 

Dear Dr. Califf:

On November 8, the American people voiced their disapproval of the type of government that ignores the input of small business owners, consumers, and job creators.  The incoming Administration and the 115th Congress will likely re-examine and unwind burdensome regulations imposed by the Obama Administration. The U.S. Food and Drug Administration’s (FDA) deeming regulation of e-cigarettes is a primary example of a rule that could eliminate an entire nascent industry. According ly, given the substantial likelihood that this burdensome rule will be undone, I urge the FDA to cease implementation of its deeming regulation to spare the growing e-cigarette industry unnecessary and avoidable compliance costs that it currently faces.

Many stakeholders have raised concerns about the costs this regulation will have on the emerging e-cigarette industry. Christian Berkey, the Chief Executive Officer of an e-liquid company located in Hartland, Wisconsin, has said that the effect of this rule on the e-cigarette industry would be “catastrophic.” In light of the significant economic costs on thee-cigarette industry and the substantial likelihood that the incoming Administration and the 115th Congress will unwind this burdensome regulation, I call on the FDA to cease its implementation of the current regulation over e-cigarettes.  I hope the FDA will acknowledge the reality of the situation and ensure that small businesses and consumers do not continue to incur avoidable financial costs due to this regulation.

Thank you for your prompt attention to this important matter.

Sincerely,

Ron Johnson, Chairman
United States Senate
Committee on Homeland Security and Government Affairs

Posted in Legal, News

Veterans Group Slams FDA Plan Regulate Vaping Industry

Veterans Are Slamming The FDA’s Plan To Smother Vaping Industry

Posted in Uncategorized

Donald Trump Can Change FDA Regulations and Save Vaping

President Elect Donald Trump is collecting guidance from US Citizens to help direct his first 100 days in office.  He could take action that saves vaping in the USA.  In its first 100 days, we need the new administration to route out the corrupt and dangerous regulations that the FDA Center for Tobacco Products, under the leadership of big Pharma lobbyist Mich Zeller has enacted.  These regulations are designed to destroy the vape industry.

Please visit the President Elect’s website and submit your  story:  https://apply.ptt.gov/yourstory/

Here is the message that I (Brendan) sent as President of Flavorah:

Please stop the FDA’s Center for Tobacco Products from destroying the vape industry. We help people quit tobacco by using technology, and the FDA has no part in our industry.  Vapor is not food, it is not drugs and it is not tobacco.

I own a business that manufactures flavoring.  My customers use our flavoring to manufacture ejuice for use with an electronic cigarettes.   For $5.49, customers purchase a .5oz bottle of concentrated flavoring, then mix it with ingredients purchased elsewhere in order to make their own ecigarette refill and help themselves quit smoking.  All my products are nicotine free, not derived from tobacco, and not used directly in an e-cigarette.

Despite the multiple steps for processing and blending our flavors, and distant—or more often non-existent linkages to tobacco—The FDA has refused to tell me explicitly if my product will be subject to their “Deeming” rules.  If they are subject to their new rules, I will be required to submit approximately $150M (according to their own figures) worth of “Pre-Market Tobacco Applications” without any guarantee that they will be accepted.

If I continue in business and assume that I am not subject to their new rules, I could face enforcement that would result in my business getting 100% shut down, and possible fines and imprisonment.

In an email correspondence with the FDA, I was told that our flavoring product could be “deemed” a tobacco product if they are packaged for consumer use.  I replied to this email with a request for clarification since my product is a raw material that must be further processed before it can be used in an ecigarette.

In Phone correspondance with the FDA, I have received continued obfuscation and lack of clarity. Since the Food Drug and Tobacco Act specifically exempts raw material that do not contain tobacco, the FDA agents can not tell me whether my product was or was not subject to their new regulations.  Instead they have been bullying us, and other members of our industry with the threat of their regulations and enforcement-new drafts of which come out every month.

Their rules, and their responses attempting to clarify them, have been impossible to follow, and their communication leaves me without a clear course of action.  Other businesses in our industry, including many of our customers, have been forced to close because they cannot afford to survive the new burden of regulations.

It is clear that the FDA director Mitch Zeller, who was a lobbyist for big pharma companies before President Obama appointed him, is trying to kill the vape industry.  On the face of it, the FDA seems like they are trying to protect tax revenues from tobacco cigarettes, and also prevent people from quitting tobacco with their own homemade mixtures of ejuice rather than a drug like Nicorette or Chantix.

The truth is, about 80% of people who use an ecigarette are able to quit smoking tobacco.  The ones who make their own refills save so much money that they rarely go back to tobacco, or commercial ejuice refills for that matter.  Ecigarettes are saving lives, even if they are causing a loss in tax revenues.

The FDA has attempted to redefine “tobacco product” so broadly in their deeming rule that it could include anything.  Literally, tap water and steel wire have the same linkages to the use of a finished tobacco product as my flavorings.

If my customers are allowed to continue purchasing flavorings from companies like mine, then they will never need to purchase tobacco cigarettes or pay taxes on newly deemed “tobacco products.” I think that scares the FDA because it makes them irrelevant.  Please send new leadership to reign in the FDA bureaucracy that threatens both jobs and lives.

Posted in Industry, Legal, News

Study Shows that Vaping is Not about Nicotine

Anybody who is in the industry could tell you that ecigarettes are a tool for reducing or eliminating nicotine.

The disconnect between understanding and regulating ecigarettes is stark however.  The notion of “Electronic Nicotine Delivery Systems,” or “ENDS” as a product category expresses a laughable lack of familiarity.  No wonder the vape community has its own terminology, namely “Vapor Product” and “Vape” to describe what an ecigarette is.

Claims that they help you “quit smoking” are of course regulated with a vengeance by the FDA, but a cursory introduction to the massive variety of ejuice flavors and concentrations available makes it obvious:  Step into a vape shop and most commercial flavors are mixed in descending levels of nicotine concentration from the cigarette equivalent of 2.4mg down to 0mg /no nicotine, with most advanced users rarely venturing above 0.3mg nicotine.

DIY mixers focus on the flavor and PG/VG ratio and the flavor profiles, and cloud chasers are all about tweaking their juice and coils for big clouds.  Nicotine is an afterthought, if it is used.  Additionally, recipes for an ejuice don’t need to specify nicotine, since most likely it is actively being reduced by the user in each new ejuice, or eliminated by whoever follows the recipe.

A new study confirms these widespread misconceptions about vapor products.

What are kids vaping? Results from a National Survey of US Adolescents

From the synopsis:

Data come from Monitoring the Future, an annual, nationally representative survey of USA 12th-grade, 10th-grade and 8th-grade students. Respondents reported what substance they vaped the last time they used a vaporiser such as an e-cigarette.

Results Among students who had ever used a vaporiser, 65–66% last used ‘just flavouring’ in 12th, in 10th and in 8th grade, more than all other responses combined. In all three grades, the percentage using ‘just flavouring’ was above 57% for males, females, African-Americans, Hispanics, Whites, and students both with and without a parent with a college degree. Nicotine use came in a distant second, at about 20% in 12th and 10th grade and 13% in 8th grade. Taking into account youth who vaped nicotine at last use increases national estimates of tobacco/nicotine prevalence in the past 30 days by 24–38% above and beyond cigarette smoking, which is substantial but far less than estimates that assume all vaporiser users inhale nicotine.

Conclusions These results challenge the common assumption that all vaporiser users inhale nicotine. They (a) call into question the designation of vaporisers and e-cigarettes as ENDS (‘Electronic Nicotine Delivery System’), (b) suggest that the recent rise in adolescent vaporiser use does not necessarily indicate a nicotine epidemic, and (c) indicate that vaporiser users can be candidates for primary prevention programmes. Finally, the results suggest the importance of developing different rationales for the regulation of vaporiser devices as compared to the regulation of substances marketed for vaporiser use.

 

Posted in Health, Industry, Legal, News

Ejuice Calculator

diy-ejuice-calculatorWe have a spreadsheet that can be used with your ejuice calculator to upload Flavorah flavors.

All of the specific gravity, use rate, and costs are in the upload.

There are a few really good applications out there for doing your ejuice mixes and keeping track of inventory, recipes, batches etc.  One that I like is made to run on your computer, and allows you to mix DIY ejuice by both volume and weight.  Using this calculator will help you refine a recipe by easily toggling between PG/VG levels and flavor percentages.  Once you have a receipe written, you can also run a cost/ml analysis to see how much money you might save.   Check out DIY Juice Calculator

Here is an easy to import spreadsheet of Flavorah Flavorings that you can use with the calculator.

FLV Ejuice Flavors Spreadsheet

FLV Flavors Import For Ejuice Calculator

Posted in Uncategorized

Vaping Enriches and Helps Sustain Lives

Vaping for Taste

This YouTube video shows us one example of how vaping enriches and helps to support lives:

Need more statistics?

This is a wonderful infographic from Vaping Cheap that helps break down the numbers for the curious or skeptical: Read more ›

Posted in Health, Industry, News

August 8, 2016. Welcome to the New Era for Vaping

Today is the first day of an unknown era. Vaping in the good ‘ole US of A may never be the same again, and whether we are going to see the twilight of its golden age, or the dawn of something newer, bigger and better is still obscured by a big white cloud of vapor…

This past Friday, August 6th we released nearly one hundred new flavors in order to keep from violating the FDA’s regulation that no new tobacco products be placed on the market after 8/8 without a PMTA.  We have also implemented age verification on our website and ended our exclusive pre-release sampling program in order to comply with the apparent inclusion of vapor flavorings as deemed “tobacco products.”

It is very clear from the updated publications on the FDA’s website, Q&A webinars held in July, and their direct correspondence with us that DIY ejuice will not emerge unscathed if things continue on the same course.

Read more ›

Posted in Industry, News

New Flavors!

As of August 7, 2016, we have launched 1oo new flavors!  Our USA Flavorah Brochure has a complete list, and you can find them for sale on the DIY Ejuice store.
This release is adding tons of amazing flavor variety to the DIY market, so please enjoy browsing and testing out these amazing new additions to the Flavorah line.

Flavorah Flavor List

 

Read more ›

Posted in Flavorah, Promotional

A Billion Lives – Documentry about Vaping

We are looking forward to seeing this documentary about vaping and the worlds regulatory response that is coming out soon. One interesting thing about it is that the director Aaron Biebert neither vapes, nor smokes.

Go to http://abillionlives.com/ to see some Q&A and to sign up for notifications. Screenings have already been made in NZ, to members of US Congress and to other important policy makers.

Posted in Industry, News

Call Your Congressman Tool – DIY eJuice Call to Action

Continued from a previous post.

Congressional Action for DIY eJuice Threatened by the FDA

Without congressional action to protect our rights, the FDA will have essentially banned vaping by “deeming” that it is a tobacco product, effective August 8th of this year.  Flavorings used for DIY ejuice are going to be regulated as “tobacco product components” and subject to these same regulations.

New education and action is needed to protect your right to choose vaping instead of tobacco cigarettes.

There is one piece of legislation we must pass called The Cole-Bishop Amendment that has been passed by committee and attached to the Agriculture Appropriations Bill. This amendment will allow any vape product marketed before August 8th to stay on the market.

It makes a difference to Advocate for your Freedom to Vape

I have worked in politics and have seen how this works.  I cannot emphasis enough how effective and important it is to call your member of congress and advocate for your rights!  Two calls a day will get the attention of the interns and legislative correspondents. Five calls will get the attention of their staff members, and anything more than this constitutes a grassroots movement.

Instructions:

  • Don’t settle with talking to an intern, ask to speak to “The Legislative Director who deals with issues related to the FDA.”
  • Bring them up to speed and explain what is going to happen to vaping in August. Chances are they know nothing about the Cole-Bishop amendment, or the FDA’s deeming regulation and its negative effect on vaping.
  • Tell your story. Tell your representative why the FDA is wrong to regulate vaping the same as tobacco. Explain to them how their regulations are exactly what big tobacco wants in order to kill vaping. Open their eyes to the realities of nicotine addiction and oral fixation that vaping solves. Show them the truth that ejuice, and electronic cigearette smoking is not a tobacco product, not a food, and not a drug.
  • If you own a vape shop, or any kind of local ejuice business, then call the local district office as well as the DC office and explain to the staff how this will destroy jobs and contribute to increased tobacco smoking in the Congressman’s district. You may even have a chance to invite the congressional staff to tour your business and lean the truth about vaping.  This is considered “field work” for a staffer and much more attractive than sitting in the office all summer.

Locate your Senators and Representative

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ex: 1600 Pennsylvania Ave, Washington, DC 20500

Talking Points:

  • Please support the agriculture appropriations bill that includes the Cole Bishop Amendment.
  • The FDA is overstepping its legal authority by regulating a tobacco free product. 
  • Legislation is needed that recognizes electronic smoking is:
    • Not a tobacco product and cannot be deemed one if it does not contain tobacco.
    • An innovative new thing that is neither a food, nor a drug.
    • A potential public safety asset for reducing the harm of cigarettes and other combustible tobacco products.
Posted in Industry, Legal, News