Today, as reminded by Greg Conley, President of the American Vaping Association, is the day the US Federal deeming regulation goes into effect for vaping and tobacco products. It is a holy day for anti-vaping advocates who will see there a series of measures that aim at limiting the access to the product to teenagers, but it is also easy to paint a picture of doom and gloom for small vaping businesses.
In brief, the FDA now has to review all vaping products on sale and no new product is allowed on the existing market now.
In the absolute, the agency should “only” be reviewing vaping products that have been introduced on the market since February 2007, but everyone knows that it represents above 99% of the market. Preventing new products from being introduced on the market is just like freezing a market in exponential growth.
Manufacturers are given two years to file applications and can keep their products in stores (provided that they comply with the clild-safety requirements of the Child Nicotine Poisoning Prevention Act). If an application has been introduced, a third year of grace is given as the administration reviews the application.
The countdown is starting today for e-liquids and any type of tobacco products, as soon as it is intended to be used with an e-cigarette, which is itself a tobacco product (of course!), with or without nicotine, extracted from tobacco crops, other type of vegetal or synthetic.
Among other things, the retailers MUST check IDs for age verification of any individual who seems young, basically until 27 years old, and vending machines are prohibited in public places unless these are restricted to adults.
But “advocates are actively working daily to convince Congress and/or the courts that the 2007 predicate date cannot be allowed to stand” declares Conley with a tone of optimism. Several lawsuits have also been launched against the Agency by manufacturers and professionals associations. “Nonetheless, challenging a federal agency is expensive and has bankrupted countless companies in the past.” A hearing on the motions is scheduled for October 19, 2016, before the D.C. District Court, a place that has already seen a first victory for vaping.
In 2010,the DC District Court ruled against the FDA, in favor of Sottera (NJoy), a case that allowed the e-cigarette not to be regulated as a drug-device combination product. Downside of the story, Judge Richard Leon commented that “the intended use of an electronic cigarette is to encourage nicotine use, rather than prevent or mitigate it” and the Court of Appeals’ decision ruled that “electronic cigarettes can be regulated solely as tobacco products“. A decision to which the FDA decided not appeal…