My Article For Vapor Consortium Magazine August 2015

Vape Products-Airbags The FDA May or May Not Allow

The e-Vapor industry is in its eighth year and it is amazing to see the vast array of evolved technologies being developed that so many Americans are now enjoying and greatly benefitting from. We are slated to surpass tobacco cigarette sales in a few years and many thousands of Americans are now generating substantial incomes creating and providing a product that is substantially NOT equivalent to tobacco cigarettes-a great thing. But for years now the e-Vapor industry and its retail clients have been living under a fog cast by the FDA. Confusion over the very existence of our industry is leading to consumers doubting our viability and many, many possibly not transitioning to e-Vapor products as a result of all the dis-information being put forward by media about e-Vapor products and their regulatory uncertainties. Retailers like CVS have discontinued the availability of a category of products in antithesis to their splashy marketing concerns of their patrons “Health”. This confusion is mainly caused by a two simple words put forth by the FDA- “Substantial Equivalency” (SE) which is their process for pre-market review of new tobacco products in which they have determined e-Vapor products are. As of this writing there are being debated amendments in Congress that are addressing SE and will remove e-Vapor products from pre-market review in effect denying the FDA’s ability to utilize SE which is a historic benefit for our industry. Other bills will simply put forward the February 27, 2007 date set by the FDA of determining when a tobacco product is considered “new” simply kicking the can down the road.

Many, many people are confused by SE and have asked what it really is and how it will affect their businesses. I would like to try and encapsulate using the following analogy for retailers and Vapers so they fully understand SE and how untenable it is for e-Vapor products and our industry. For arguments sake let’s equate the FDA to the National Highway Traffic Safety Administration (NHTSA) and all tobacco products to all transportation products. Let’s also assume that Henry Ford’s 1908 Model A is the only automobile available and has not evolved since first built. Fast forward to 2009 and due to the 450,000 Americans that are dying annually in Model A car accidents, the U.S. government passes a law called the “Automobile Control Act” (equitable to the 2009 Family Tobacco Control Act) giving the NHTSA regulatory authority over all transportation products as many see autos as a very deadly consumer product. In 2007 the Dodge Brothers come along and seeing the dearth of casualties caused by the Model A, invest their personal dollars and talents in developing a new, vastly less harmful automobile. Their car has seat belts, cushioned dashboards, 9 airbag restraint devices, crumple zones and many other safety features unavailable in the Model A, creating a truly vastly less harmful product. Consumers are transitioning to their vehicle by the millions. Lives are changed. Families are bettered. New careers have been created, businesses opened and state, local and national health care costs are falling. Amazing times.

All is great for the Dodge Brothers, their employees and mostly-their clients. The free markets have worked as they do to advance/evolve a consumer product changing millions of lives for the better-right up until the NHTSA seizes the Dodge Brothers inventory claiming it is an “unapproved transportation vehicle” as it does not pass their scrutiny under the NHTSA’s new SE provision. The NHTSA’s new SE provision states that “New transportation products may not be legally marketed in the United States unless NHTSA has issued an order permitting their marketing.”  The NHTSA’s SE provision mandates “A substantially equivalent transportation product has been found by NHTSA to have the same characteristics as a predicate transportation product”. The Dodge Brothers floored by this ask the NHTSA what they must do to keep their new products on the market are told that for them to keep their safe, vastly less harmful products available to consumers they must submit a form. Once their form is submitted, the NHTSA will “determine if the new transportation product is substantially equivalent to Model A’s and is in compliance with the requirements of the law. If both of these criteria are met, NHTSA will issue a written order permitting the product to be legally marketed in the United States. You cannot legally market a new transportation product if you receive an NHTSA order stating that the product is not substantially equivalent.”

So here we are today. By SE mandate a dutiful FDA bureaucrat will review a submitted e-Vapor form then look in one hand at that e-Vapor business owners submitted for approval product and in the other hand look at a pre-February 27, 2007 approved tobacco cigarette and determine if they are Substantially Equivalent. Obviously this will never happen as all e-Vapor products are purposely designed NOT to be SE to the one product we know kills over 450,000 Americans annually-a predicate tobacco cigarette. I do hate to sound dire but SE is dire and obviously not a tenable provision that the FDA can retain in order to keep e-Vapor products available to Americans who are greatly benefitting by their very construct. It is this construct and advancement that is causing so much consternation. What to do? FDA Center for Tobacco Products head Mitch Zeller has made recent remarks stating “If we could get all of those people [who smoke] to completely switch all of their cigarettes to noncombustible cigarettes [i.e., vapor products], it would be good for public health. ” These are very positive sentiments as Mr. Zeller has the unenviable task of keeping e-Vapor products available and upholding legislative mandates. We, the TVECA, have met with Mr. Zeller and he was very open to listening to our positions and recommendations.

Fortunately there are those elected officials in Washington DC who are working on our industry’s behalf to keep our historic momentum moving forward.  We do hope that sensible positions are heard and that Americans will have unfettered access to our very viable products.

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