Rooted in the code of federal regulation and the various three and four letter agencies lies an interesting inquiry with respect to the future of “smokeless or alternative” products for those interested in the non-tobacco based world of what is modernly called “vaping”.
This legal brief is merely a synopsis of the past and current situation with respect to the industry as a whole including my traditional straight forward analysis of the legal and regulatory environment having worked in the health and wellness regulatory community for over 20 years. The following is a historic review of significant events:
In 2008, the FDA attempted to regulate E-cigarettes as a “drug” or drug delivery device under the FDCA, Federal Food, Drug and Cosmetic Act, by blocking a shipment at the borders of the United States. In 2009, NJOY, the manufacturer and Soterra, the distributor of the product sued by simply asserting the FDA had no authority based on the lack of drug or drug delivery device status. The FDA would not appeal as it was baseless.
By 2010 the matter reached federal court attention and is probably studied in law schools today as an example of several key legal constructs fundamental to US law. Much of the basis for the future of “vaping” was established in 2000 with the benchmark precedent case FDA v. Brown & Williamson. This established a basis for the FDA’s inability to regulate tobacco products and soon to be nicotine based products. In frustration, congress created the Tobacco Control Act adding cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless (chewing) tobacco to the sole categories of FDA regulation.
Two major understandings exist to warrant the support of “vaping” in the future. The first is that the federal government always defaults to a fundamental called State Police Powers when issues of consumer choice are involved. This is rooted in the founding of our constitution. States are left with the ultimate power to decide what is to be regulated in their own borders and the consumption of alcohol in Utah vs Tennessee is a classic example. The second point is the fact that regulatory gaps exist in favor of the future of “vaping” and the primary gap that has the test of time and federal court precedent is the fact that a nicotine based product, tobacco derived or not is NOT a “tobacco product” (House Bill 2 S.L. 2009-27).
Add the fact that former Bush administration Surgeon General Richard Carmona M.D. is a proponent of the industry as a significant improvement in the healthful delivery of nicotine and smoking alternatives. Such an advocate that he is directly involved in the manufacture and sale of the liquid supplies required for “vaping”.
The successful future of vapor distribution will reside in the traditional existence of hundreds of consumable products including, alcohol, OTC drugs, tobacco, and many others that require one thing; Responsible and conscious marketing. Clearly protecting children, product potency (nicotine), safety of mechanisms (pipes) ALL need to be conscious decisions by industry executives to create safety and quality product experiences. As with many like industries, the future is bright if handles responsibly and the track record of responsible marketing is relatively easy to follow.