The U.S. government is notorious for stepping in and over-regulating any new, groundbreaking product that enters the marketplace, and the vaping industry is no different. Until about ten years ago, electronic cigarettes were virtually non-existent. But over the past few years, millions of people are switching from conventional cigarettes to e-cigs. Any commercial transition of this magnitude always draws the attention of government agencies like the FDA.
The FDA deeming regulations were first announced last May, but one of the most controversial protocols listed in the nearly 500-page document was the need for all retailers and manufacturers to file a Pre-Market Tobacco Application (PMTA) that costs in upwards of $1 million per product. If this wasn’t bad enough, the FDA retroactively required the PMTA on all products released to market after a February 2007 predicate date. In short, the U.S. government wants to roll back the clock on nearly 99 percent of all vaping products, essentially back-taxing them out of existence if the manufacturers don’t pay up.
FDA deeming regulations and ‘tobacco products’
Another interesting tidbit buried deep within the FDA deeming regulations is the new classification of all e-cigs and vaping gear as “tobacco products.” While most but not all electronic cigarettes contain an infinitesimal amount of nicotine compared to conventional cigarettes, no vaping products of any kind contain tobacco. Tobacco is not nicotine. They are two completely different things.
The notion of the FDA trying to tax e-cigs in the very same way that it taxes a pack of Marlboros is simply ludicrous in the minds of the vaping industry. Yes, some e-liquids contain nicotine. But even those that don’t are still considered “tobacco products” by the FDA and, therefore, require the million-dollar PMTA.
Furthermore, lots of other consumer products contain nicotine, as well. And they aren’t taxed by the FDA. Eggplant, tomatoes, and potatoes, for example, all contain a natural amount of nicotine. To tax e-cigs as tobacco products would be as ridiculous as taxing an eggplant in the very same manner.
The FDA deeming regulations and the Nicopure Lawsuit
The FDA deeming regulations are officially in effect, but retailers have a full two years to comply. This two-year grace period gives the vaping industry time to fight. Within days after the deeming regulations were announced, a Florida-based e-liquid supplier filed a lawsuit against the FDA in Federal District Court. Nicopure Labs was joined by several other retailers and vaping advocacy groups, one of which is the uber-powerful Right 2 Be Smoke Free Coalition.
The judge just began hearing oral arguments last week, and the lawsuit could drag on for months or even years. But the Nicopure v. FDA lawsuit is historical. Its outcome could help drive public policy on vaping for decades to come.
Mom and Pop vape shop owners desperately want Nicopure Labs to win. And so should the average vaper. If the FDA deeming regulations remain in their current state, then most economists predict that nearly 99 percent of all vaping product currently on the market will no longer be available due to the high-priced PMTA requirement. The vaping industry, as we know it, will cease to exist.