Big gov will crack down on everyone and most likely push back on legalization... Statically 200 deaths among millions of users is still safer than driving a car, but if your love one is affected it’s a real tragedy
This is more of a small government problem, IMO, but bigger government alone isn't the solution. Government, specifically, regulatory agencies need to be both bigger
and better.
In this case, FDA has both the authority and the resources to regulate e-cigarettes, but it's used its discretion to delay requiring pre-market approval for these product, first until 2022, then 2021. Recently, a federal court removed this discretion and pushed up the final deadline to May, 2020.
FDA's authority includes tobacco e-liquids as well as any devices that could be used to vape them. FDA was careful to name potential dual-use devices like vape pens in its regulations and guidance for industry. So, it could require pre-market approval for these devices as well. AFAIK, FDA has no authority to regulate products that are derived from cannabis or used exclusively with cannabis, unless they make health claims, and it won't be getting that authority anytime soon.
To gain approval, manufacturers need to demonstrate that their products are "appropriate for the protection of the public health", a very high standard for products that are known to present health risks. Manufacturers need to show that their products are less hazardous than comparable products on the market. So, for example, e-cigarette manufacturers would need to show that e-cigarettes are less harmful than combustible cigarettes. Cigarette smokers who switch would be reducing their risk. But FDA also needs to account for non-smokers who initiate tobacco use with e-cigarettes. The reduced risk for smokers must be greater than the increased risk for non-smokers.
Meeting this standard is likely to be very difficult. It will require significant scientific and legal resources. It's likely that only large companies will be capable of preparing complete applications that FDA will review, let alone approve.
IMO, FDA does not have a plan to fully implement the 2009 Tobacco Control Act with regard to new tobacco products. So far, it's mainly been denying marketing applications or refusing to even consider them. The only inhalable product that's been approved is Philip Morris International's IQOS heated tobacco system, out of hundreds of applications, and PMI's request to claim that their product was less risky in marketing materials was denied.
And we're up to 450 reported cases in 33 states.
