Following the 2016 elections, some vapers were optimistic about changes at the FDA Center for Tobacco Products. While there were no promises or specific evidence to base this on, the feeling was that regime change would make a difference, as the FDA would no longer answer to the fairly anti-vaping Democratic Party leadership. The recent response by FDA Commissioner Scott Gottlieb to anti-vaping remarks by Senator Chuck Schumer leaves some serious doubt about that.
Whatever their political preferences on other issues, politically aware vapers know that almost every political attack on vaping, at the national, state and local levels, comes from the Democratic side of the aisle. Some elected Democrats have stood up for vapers and the industry, of course. For most the issue is not really on their radar; they just follow their leadership if they face a vote on the issue and respond to constituents with form letters that contain talking points that their own staff clearly did not write or even understand. But a few party leaders like New York’s Senator Schumer are rabidly anti-vaping and proactively address the issue.
In a Sunday press conference, Schumer, the Senate Minority Leader and serious contender for being considered the leader of his party, criticized the FDA and e-cigarettes, particularly the cartridge cigalike Juul. There appears to be no available complete video or transcript of his remarks. Schumer’s office did not issue a written statement or post the video in one of its channels. But video and quotations published by the New York press corps presents a fairly complete picture of a series of often absurd claims. These were uncritically repeated by the mainstream media.
Schumer targeted the Juul, calling it new (two years is a long time in vape years) and offering a bizarre theory about how it is somehow easier for minors to conceal than other e-cigarettes. He constructed a horror story of e-cigarettes being everywhere in New York high schools. The amNewYork newspaper reported Schumer made the inevitable statement about “kid-friendly flavors” and asserted, “e-cigarette companies are stepping over the line to market these products to kids, to get them hooked to smoking.” Most important, Schumer suggested that the FDA has basically stopped regulating e-cigarettes. This – whether genuine confusion on his part or intentional disinformation – was presumably a reference to the four-year delay in the new product approval requirement, confusing it with a halt to all regulation.
Indeed, the news reporting was often even more misleading than Schumer himself. In the press conference, he started to say that a recent survey showed that one in five New York high school student uses e-cigarettes, before he corrected himself and said “has used.” But the press largely ignored the correction and reported that one in five use e-cigarettes. Among the newspapers making that error in was The New York Post, in an article that Gottlieb tweeted out shortly after it appeared. The Post article made that claim in its lead sentence, amending it in the tenth paragraph to “used e-cigarettes in the last year.” However this too seems to be inaccurate since the survey the claim was attributed to did not actually ask about use in the last year. It asks only about intensity of current use and “have you ever tried…?” Presumably the one-in-five statistic is for ever having tried, which is roughly what Schumer actually said.
Within a day of the press conference, Gottlieb tweeted seven times indicating his agreement with Schumer. He could have pointed out some of the numerous errors in Schumer’s claims. He could have defended the FDA against the absurd claim that regulations were halted. Instead he became perhaps the first official in the current administration to actively endorse criticisms of his work by a Democratic senator.
Gottlieb chose to amplify the Post article which contains a series of false claims about e-cigarettes, some from Schumer and some added by the author. More significantly, in its lead sentence, the article describes FDA policy as “a recent decision to delay the regulation of e-cigarettes.” It later reiterates the claim with, “the Food and Drug Administration decided to hold off on implementing an already finalized rule that would regulate e-cigarettes.” The Post goes on to transcribe from Schumer, “Up until now, the FDA was on track to reign in e-cigs and regulate them like any other tobacco product, but this recent delay, coupled with the new numbers showing a rise in the use of gadgets like Juul, which can fool teachers and be brought to school, demands the FDA smoke out dangerous e-cigs and their mystery chemicals before more New York kids get hooked.”
Why would Gottlieb endorse Schumer’s absurd misinformation, let alone his mischaracterizations of what the FDA has done and is doing?
The most reassuring answer for vapers might be that he is hoping to get Schumer’s vote and support for his rumored possible nomination to replace Tom Price as Secretary of the Department of Health and Human Services. However, Trump cabinet nominees do not need Schumer or the Democrats to get confirmed.
The more disturbing explanation is that the FDA still considers Schumer and his allies as the politicians they answer to on vaping regulation and tobacco policy more generally. The Center for Tobacco Products leadership, personnel and policies are unchanged under the new administration. Gottlieb himself is primarily interested in the FDA’s other larger units. The political leadership of HHS, let alone the White House, have even less interest in delving into CTP.
The four-year delay in the prohibitively expensive new product approval requirement is obviously important, basically a stay of a death sentence. But the new administration’s FDA has done basically nothing else to provide relief to vapers and the industry. Other rules have been enacted as scheduled, setting aside deadline delays due to the FDA’s technical problems. The vapor industry can no longer introduce new products and has just experienced the first round of onerous registration requirements. A few days before Schumer’s press conference, the FDA issued a guidance clarifying that free samples of vapor products were banned outside of adult-only venues making clear that the FDA is taking action against underage access. While some have expressed optimism about Gottlieb’s supposedly pro-harm-reduction rhetoric, it has been little different than the rhetoric from CTP Director Mitch Zeller had repeated for years, even as he pursued the rapid death sentence for the industry.
It appears very possible that Gottlieb – or his underlings at CTP to whom he yielded in determining his response to Schumer – want Schumer’s accusations to stick. That is, they may want to be seen as not doing enough to interfere with the market for vapor products. This would provide political cover for the damage they have already done and offer an excuse to do even worse. That goal could explain why Gottlieb chose to actively endorse inaccurate criticisms of FDA policy, thereby amplifying the resulting political pressure.
If the FDA’s cozying up to Schumer’s criticism means that they are still taking directions from him, or if it means that he just offers convenient cover for CTP’s own political preferences, the implication is not good for FDA vaping regulation.
