Substantial Equivalency Review

The e-Vapor market has entered it’s eighth year serving the American market and that is a good thing. The industry has overcome mind numbing attempts to curb and even eliminate its existence and we keep rolling along providing products for over 6 million Americans. There are still though hurtles remaining. One such is the FDA’s process of “Substantial Equivalency” (SE). As defined by the FDA in regard to tobacco products the agency states:

New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However, if a new tobacco product meets the following criteria:

  1. It was commercially marketed after February 15, 2007 but before March 22, 2011; and
  2. A Substantial Equivalence Report was submitted by March 22, 2011,

then this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to an appropriate predicate product.

 http://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/NewTobaccoProductReviewandEvaluation/SubstantialEquivalence/default.htm

To explain this simply, the FDA in 2008 was given the domain to regulate tobacco products when the house passed the Family Protection and Control Act. At this same time electronic cigarettes were gaining sales momentum and garnered notice by the FDA. In the landmark decision of Sottera v The FDA in which in e-Vapor industry successfully sued the FDA to categorize e-Vapor products as simply a tobacco product and not the categorization the FDA sought which was for the product to be drug device combination. It was our position then as it is now that e-Vapor products are the same as the centuries old tobacco cigarette as our products deliver nicotine to the lungs via a pulmonary action the same as does a tobacco cigarette-that’s all. The courts interpreted e-Vapor as a tobacco product and as such it is our position that as a centuries old product we are definitely not a “new” product and as such do not fall under the FDA’s decree of needing to file for SE.

We hope the industry and public understands this as it is almost an impossibility if indeed e-Vapor has to follow the path of substantial equivalency, that the FDA as an agency simply would not at all be able process the massive amount of paperwork required to approve all current e-Vapor products that are marketed. By its own guidelines each e-Vapor e-Liquid flavor, be it an open or closed source system, would have to file for SE at a cost of hundreds of thousands of dollars per flavor. For any firm that say has 7 differing flavors at 4 differing nicotine levels that alone is 28 separate filings and as there are now purported to be over 1,500 e-Vapor firms nationally, that is 42,000 separate applications the agency would have to process, review and make a decision upon. The cost alone of even filing for a single sku SE for a firm would be untenable and would put out of business the vast majority of e-Vapor firms serving American vapers today.

It is our hope that the FDA would realize after seven years on the market that e-Vapor products have proven themselves to be a godsend for Americans and that SE is not required nor should it be implemented as to do so would be the end of the e-Vapor market except for the three really big firms now in the market that could afford the process-and that would be simply un-American.

Leave a Reply