The FDA and the e-Vapor Dilemma. The History of e-Vapor Regulation

Recently there has been a great amount of concern about the issuing of the FDA’s final Deeming Regulations of the Tobacco market. There is great misunderstanding of the history of the e-Vapor industry and how and why we are regulated as a tobacco product. I would like to submit to the reader a history of how we got  to this point and why the FDA has domain to regulate the e-Vapor market:

The History of e-Vapor Regulation

October 9, 2015 “The e-Cig Industry Should Be Put Out of Business”-Senator Edward Markey D-Massachusetts

After the landmark court decision Smoking Everywhere vs. The FDA (Concluded as Sottera v. FDA) that forced the FDA to regulate e-Vapor as a tobacco product and not an illegal drug-device combination as the FDA sought, the industry has held its collective breath in anticipation of the FDA’s final rules. It is anticipated that these final rules will, if not legislatively defeated, eviscerate over 90% of e-Vapor’s $3.5 Billion market.

We, the TVECA, have been working with the FDA on viable, responsible regulations and we are now working with principals of tobacco and e-Vapor companies to formulate our strategies in defeating the proposed final rules. Speaking to individuals though, many are not aware of why we fought for e-Vapor products to be regulated as a tobacco product and the answer is concise-if not, there would not be an e-Vapor industry in the U.S. at all as the FDA in 2008 was actually seizing shipments of incoming electronic cigarettes claiming they were an illegal drug device.

In order to fully understand why the FDA took that tact and caused us to successfully litigate you have to know the history of tobacco regulation and how and why the FDA ended up with the responsibilities of regulating now not only e-Vapor products but the entire domestic tobacco industry.  First in 1938 Congress passed a set of laws called the Federal Food, Drug and Cosmetic Act (FD&C). This act gave the FDA the authority to oversee the safety of food, drugs and cosmetics. In that capacity The FDA subsequently argued that nicotine was a “drug” and cigarettes and smokeless tobacco are “devices” that deliver nicotine to the body within the meaning of the FD&C act. Fast forward to the year 2000 and the court case of Brown & Williamson vs. the FDA. This litigation was based on the FDA’s assertion of authority over the production and sale of cigarettes. This was based on the FDA’s finding that nicotine was a drug and that cigarettes were thus a drug delivery system. The FDA proposed to regulate cigarettes as a hybrid involving both a drug and a medical device. The FDA proposed rules through notice and comment rulemaking and when these rules were finalized, Brown & Williamson moved to have them enjoined because they exceeded the FDA’s statutory authority. The Supreme Court agreed stating that the FDA overreached and conceded that congress had been silent as regards to the FDA’s authority to regulate tobacco.

Fast forward again to 2009. Congress passed the “Family Smoking Prevention and Control Act” giving the FDA new powers to regulate the tobacco industry. The law imposes new warnings and labels on tobacco packaging and their advertisements, with the goal of discouraging minors and young adults from smoking. The Act also bans flavored cigarettes, places limits on the advertising of tobacco products to minors and requires tobacco companies to seek FDA approval for new tobacco products. At the same time this Act was being debated by Congress the electronic cigarette industry was just beginning. There were a few companies that invested their time and treasure to bring these fabulous new products to market-one of them being the company I co-founded with my partners in 2008. Let me make one point very clear-Tobacco companies did not have any influence or investment of any of the first-to-market e-Cig companies. ALL were founded by individuals who saw an opportunity to market this vastly less-harmful product to smokers giving them their first real viable option to the smoking of tobacco cigarettes-the one product we know kills over 450,000 Americans annually. Tobacco companies did not enter this market till mid-2012.

In 2008 the FDA seized a shipment of TVECA Co-Founder Ray Story’s Smoking Everywhere e-Cigarettes. The basis for this was again the assumption by the FDA that nicotine was indeed a drug and these “new” products were an illegal drug-device giving the FDA domain under the 1938 FD&C Act to regulate the products. Unfortunately for the FDA, they vastly underestimated the tenacity of Mr. Story who brought suit against the FDA for illegally seizing his property. Mr. Story then filed suit against the FDA in Smoking Everywhere vs. the FDA. The FDA lost in district court and appealed and on December 10, 2010 the Washington D. C. Appellate Court sided with the industry claiming that indeed that e-Cigarettes were a tobacco product as their nicotine used was derived from leaf and stem of the tobacco plant.

This was a stunning blow to the FDA. Below is the current passage from the FDA’s website on this decision which was settled as Sottera vs the FDA:

The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), recently issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products” and “drugs,” “devices,” and combination products, as those terms are defined in the FD&C Act.  The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes.

 The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera

This brings us to our dilemma today. As the FDA is granted the new authority of regulating the tobacco industry it is doing what a regulatory body does-regulate. Sadly for now 6 million Americans using e-Vapor products and the tens of thousands of us whose livelihoods are provided by our e-Vapor firms, the FDA’s again over reaching threatens to put us out of business and hand our beloved industry to very large tobacco companies excluding small to mid-sized firms who built the industry to stay in business and thrive.

What to do? We the TVECA, are preparing legal and legislative actions to stop this massive overreach. We have been successful in the U.S. and in the E.U. where we lobbied for over two years in 27 different countries to keep e-Vapor available as the E.U. was headed down the same path as the FDA claiming these products are indeed drug-devices and not tobacco products and have to be pulled from the market. It is now our quest to fight for our industry and keep these products available as a legal tobacco product as if they are anything but a tobacco product they are open to cities, states and other governmental agencies fabricating their own individual bans on our products.

 

 

 

 

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