The e-cigarette has stirred up some controversy that it may be unable to withstand. The Food and Drug administration had taken a hands off approach to e-cigarette brands like blu, MarkTen, and Juul, which will allow nicotine users to take their hits using vaporized liquids instead of burning tobacco leaves. Current law says such products must get the FDA approval before they enter the market. FDA in 2016 decided to allow them to stay in market until 2022 without those approvals. September 12, 2018 the agency threatens to reverse the rules saying that if e-cigarette manufacturers don’t find a way to limit use of their products with adolescents, a problem the FDA says has reached “epidemic proportions” it may pull some of them from the market.

What is bad for companies such as Juul, which sports a $16 Billion valuation, Altria Group, which makes MarkTen, and Fontem Ventures BV, which makes blu, is that Gottlieb, who had seemed friendly to the industry, threw blame for the FDA’s enforcement action back at the companies.

The FDA today sent letters to JUUL, Reynolds American, Altria, Fontem Ventures, and Japan Tobacco International saying that if they don’t propose substantial steps to prevent kids from using their products within 60 days, the FDA will “reevaluate” whether it is really okay to allow them to wait until 2022 to go through the approval process. That would mean those products could not be legally sold. The agency also said that any products introduced since August 8, 2016, would need to go through regulatory review.

This is a big deal. The 2009 law that gives the FDA the power to regulate tobacco says that new tobacco products (e-cigarettes count) must show whether the product improves public health. That means that e-cigarette makers will have to demonstrate with scientific data that Americans will be healthier as a whole because e-cigarettes exist. This is a high bar, and it’s very possible that the FDA could decide that, for instance, the public health benefits of e-cigarettes may never match the risks. The FDA is also going after stores that sell e-cigarettes to minors.