On May 5th, 2016, the US Food and Drug Administration issued new Tobacco Deeming Regulations that require all e-cigarette products launched after Feb. 15, 2007 to undergo a Pre-Market Tobacco Application (PMTA) process that will cost $1 million per product application and require approximately 500-1,500 man hoursto complete (with no guarantee of approval). The small businesses that characterize the vaping industry will not be able to meet the financial burden, and will be forced to close, which in turn will leave ex-smokers who have successfully switched over to the less dangerous option of vaping with no other option but to go back to smoking.
As of May, 2016, there are an estimated 110 small vape businesses (retail shops and product manufacturers) in the Commonwealth who employ approximately 750employees, lease roughly 150,000 square feet of commercial real estate, and generate an estimated $40 million in sales and $2.5 million in MA sales tax. Under these new Deeming Regulations, this industry will be destroyed virtually overnight.
In the past 5 years, the use of e-cigs as a less-dangerous alternative to traditional, combustible tobacco cigarettes has grown exponentially. There are currently an estimated 9 million ex-smokers who have switched over to vaping. Tobacco industry analysts anticipate US sales of all e-cigs (electronic nicotine delivery systems) will expand to more than $4 billion in 2016. This includes vape products sold by small businesses (typically called “open tank systems” which are refillable) along with the vape products sold by Big Tobacco and distributed in convenience stores and gas stations across the United States (referred to as “cigalikes”,which are for the most part, not refillable).
Almost all vapor products currently on the market were released after February 2007 and therefore will be subject to the FDA’s PMTA approval process. The only companies which will be able to support this regulatory burden will be the Big Tobacco companies, whose “cigalikes” are widely considered to be inferior to “open tank systems”. (The success rate of smokers who quit with Big Tobacco’s cigalikes is estimated at 11%, while the success rate of smokers who quit using the “open tank systems” offered by small businesses (vape shops) is 25% (Kings College, London). There are many proponents of e-Cigs who are concerned about the FDA’s apparent decision not to seriously consider the significant amount of scientific research conducted by reputable institutions which proves that inhaling nicotine vapor is significantly less dangerous than inhaling smoke from traditional tobacco cigarettes. For instance, on August 19, 2015, an expert independent review commissioned by Public Health England (PHE), an agency of the UK’s Department of Health, released its findings stating that “Electronic cigarettes are 95% less harmful than combustible cigarettes.” On April 28, 2016, the Royal College of Physicians released a report that concludes that “Vaping can prevent almost all harm from smoking.” The UK now routinely provides smokers who what to quit with their choice of a nicotine patch, nicotine gum, or an electronic cigarette.
Stacy Poritzky, President of the Massachusetts Smoke Free Association (smokefreema.org), and co-owner of 4 vape shops in Greater Boston (Vape Daddy’s), states, “We hear stories daily from decade-long-smokers who say they have tried countless times to quit smoking unsuccessfully using nicotine gum, nicotine patches and prescription pills – but have finally ‘kicked the habit’ with e-Cigs due to the more sophisticated systems’ ability to deliver nicotine while providing virtually the same sensation as smoking.” Poritzky added, “When we ask vapers what they will do when only Big Tobaccos’ inferior ‘cigalikes’ are available, many say ‘cigalikes never worked for me…I’ll go back to smoking cigarettes’.”
The Massachusetts Smoke Free Association, along with countless other opponents of the new FDA regulations are actively attempting to rally e-Cig users and bi-partisan members of State and Federal Legislative bodies behind the following two pieces of legislation currently in the US Congress:
HR 2058 – FDA Deeming Authority Clarification Act of 2015 Bill will amend the Federal Food, Drug and Cosmetic Act to revise premarket review and reporting requirements for products deemed by the FDA to be tobacco products. In essence, a product is not subject to premarket review by the FDA if it is introduced to market before that type of product is deemed a tobacco product. Rep. Tom Cole (R – OK)
Cole/Bishop Amendment to the 2017 Agricultural Bill would change the grandfather date specifically for deemed products from February 15, 2007 to the effective date of the Deeming Regulation (August 8, 2016). Rep. Tom Cole (R – OK) and Rep. Sanford Bishop (D – GA)
According to Jay DeLuco, VP of MASFA, “Without the support of thoughtful Federal-level legislators and a groundswell of former smokers/now vapers, there is the distinct probability that the current FDA Regulations will put an end to the most promising alternative to smoking ever discovered. Yes, there are risks that need to be investigated, but if properly addressed, vaping products could play a role in saving more lives than almost any previous anti-smoking invention on the market today – including all the alternatives from the Big Pharmaceuticals.”
Vape shops around the state have been asking vapers interested in impacting future legislation to visit www.Mass.Gov, click on the following links: Government, then Legislative Branch, then Federal, then US Representatives for Massachusetts. There they can select their US Congressperson (from the appropriate 9 Districts) and send them email or call them, telling them about the role vaping has played in helping them successfully quit smoking, and asking their US Congressperson to vote for the passage of HR 2058 and the Cole/Bishop Amendment to the 2017 Agricultural Bill. Poritzky added, “If members of the US House in DC are unaware of the importance of altering the FDA’s new regulations, there is a distinct probability that small business vape retailers will be wiped out in the next two years – handing the vape industry to Big Tobacco.”
The Massachusetts Smoke Free Association (MASFA,www.SmokeFreeMA.org ) is a consumer advocacy group and trade organization with a focus on Tobacco Harm Reduction (THR) through the use of personal vaporizers (electronic cigarettes) and other smokeless tobacco products shown to reduce the morbidity and mortality associated with smoking traditional combustible tobacco products. MASFA is a 501c6 not-for-profit organization which seeks to cooperate with both government and health organizations throughout the state in order to achieve this goal. Formed in 2015, it also monitors for legislation, for or against, affecting tobacco harm reduction.
