An Open Letter to Acting FDA Commissioner Sharpless
An Open Letter to Acting FDA Commissioner Sharpless – By Chris Howard, Vice President, General Counsel, & Chief Compliance Officer, E-Alternative Solutions, LLC.
Dear Acting FDA Commissioner Sharpless,
On behalf of my colleagues at E-Alternative Solutions (EAS) and as an advocate for the vapor industry, I address our pressing concerns regarding electronic cigarettes and other vapor products.
First, we support your initial, even-handed approach to handling issues related to the vapor industry. During your brief tenure, we have been pleased to see your commitment to making decisions based on science – as opposed to letting emotion, conjecture and propaganda drive FDA’s regulatory agenda. From not delivering policy messages via Twitter to not bowing to unjustified bullying from Senator Durbin and others in an increasingly hostile contingent in Congress, you have demonstrated the type of rational leadership which the vapor industry has sought, and which millions of adult smokers desperately need to better their lives.
We share your goal of improving public health. More specifically, the vapor industry seeks to provide adult smokers an option beyond “quit or die.” While vapor products may not be “harm-less” as Surgeon General Adams has said, they are dramatically less harmful than combustible cigarette products – and, as you are aware, the scientific literature overwhelmingly supports this fact. Driving current smokers who won’t or can’t quit to electronic cigarettes and other vapor products is good public health policy and the ethically right thing to do.
We share your goal of preventing youth use of vapor products. At EAS, “Vaping for Adults™” (one of our marketing taglines) means something. In 2016, long before the youth vaping or “Juuling” craze existed, EAS implemented strict, self-imposed marketing standards aimed at preventing youth access and exposure to our products and advertising. Subsequently, we worked diligently with other Board members of the Vapor Technology Association (consisting of 800+ members) to develop industry standards for membership prioritizing the same principles. We continue to engage with members of Congress, FDA, FTC and other regulatory agencies to ensure that curtailing youth access and exposure is prioritized by all. It also goes without saying that we remain committed to strict age verification rules and practices. In sum, youth use of vapor products is a detriment to our company’s mission to provide safer alternatives to adult smokers – and we want it to end.
We share your goal of science-driven regulation of our industry. Short-term, kneejerk reactions to long-term problems do nothing to provide certainty or, in many instances, solve the problem addressed. As we all have witnessed, regulation through Tweets, blogs, and interviews does little to advance alternative pathways to better public health. On the other hand, data driven regulatory policy has proven effective to advance public health. The industry longs for FDA’s guidance on expectations. Since the implementation of the Deeming Rule in 2016, we have lived in a world of uncertainty and watched as several have abandoned the category as a result to pursue other endeavors. We eagerly await final PMTA guidance, HPHC guidance, product standards and GMPs, but as of yet, the Agency has not fulfilled our reasonable requests. The time for change is upon us.
Since 2018, the vapor industry has faced vilification and chaotic regulatory policy at the hands of the media, Congress, the public health community and the Commissioner’s Office itself. We recognize bad actors exist within our ranks, but these individuals are now few and far between, and the entire industry should not be demonized as a result. This is not “Big Tobacco” of the prior century. Rather, vapor companies are, and desire to be, partners in protecting the public health.
Commissioner Sharpless, we know the industry and your office have common ground on which to build effective regulation for vapor products. We are optimistic you will engage with, rather than spurn, the vapor industry and capitalize on our knowledge to prioritize harm reduction and to find a reasonable path forward. Guide us and give us the needed time – and we will rise to your expectations. We at EAS remain eager to work with the Agency to achieve such reform.
General Counsel and Chief Compliance Officer, E-Alternative Solutions (EAS)
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