Controversial FDA rules for e-cigarette producers will badly damage the growing vaping industry. The regulations, finalized in August, require that any product not on the market before 2007—when there were no vaping products available—undergo a costly retroactive application process for federal approval in order to continue selling their wares.
The incoming administration’s anti-regulatory stance has vaping advocates feeling bullish about the dawning Trump years. When these so-called “deeming regulations” became final in August after a years-long rulemaking process, it seemed the whole of the independent vaping industry might be doomed to bankruptcy. Complying with FDA’s premarket review could cost a manufacturer upwards of a million dollars.
But the possibility the Trump administration might be friendly enough to free market innovation to step in and overturn these burdensome regulations gives vapers a new hope. Now, they look for follow through.
California congressman Duncan Hunter, aka the vaping congressman, cosigned a letter to Vice President-elect Mike Pence along with fellow e-cig advocate Senator Ron Johnson of Wisconsin. In the letter, obtained by Paul Bedard of The Washington Examiner, Hunter and Johnson urge the Trump administration to “reign in” the “burdensome” FDA rule.
This is not Johnson and Hunter’s first vape-defense rodeo. Johnson was supportive of a bipartisan rider on the omnibus that would have pushed back the deeming rule’s predicate date and allowed more vape-makers to be grandfathered in under FDA’s costly regulation. But he status-quo omnibus the amendment rode on gave way to a continuing resolution—without the predicate postponement. But now, anticipating a friendlier administration, vapers like Congressman Hunter have greater cause for hope.
Advocates for 15,000 independent vaping companies may expect the assault on their industry to soften under the incoming administration. Still, Gregory Conley, president of the advocacy group American Vaping Association, told THE WEEKLY STANDARD that, even with support from the Trump administration, the likeliest path forward is to stay the course.
Vaping advocates will continue to push for a postponed predicate date—but plan to follow with an act of Congress. “The most likely scenario for keeping 15,000 businesses alive is that the predicate date is changed this year,” Conley said. “And that we begin the process in Congress of setting up an alternate regulatory system for non-combustible vapor products.”
This legislative effort in Congress would be spearheaded by Congressman Hunter, who was the second member of Congress to endorse Trump’s campaign for the presidency, and who has publicly expressed intent to introduce legislation seeking to establish a separate regulatory class for e-cigarettes.
Distinct regulatory classification for vapor products couldn’t come a moment sooner, according to Dr. Mike Siegel, a public health advocate and Boston University professor whose research focus is tobacco control policy. He advocates a harm-reduction approach to risky behaviors such as habitual nicotine intake.
Congress should require the FDA to set safety standards, Dr. Siegel said. “Rather than going through this cumbersome pre-application approval process, they should simply promulgate regulations for safety.” Battery safety and temperature control, he said, are key.
But as it stands, every updated product requires FDA approval, so independent vape companies cannot improve the safety of the e-cigarettes they market—even ones with exploding batteries.
“Ironically, what was apparently intended to protect the consumer is actually going to hurt the consumer,” Dr. Siegel said. “It means that companies cannot continue the process of ensuring the safety of their consumer.”
Changing the predicate date is a small intermediary step. The incoming administration, supported by a Republican congress, may make for an encouraging outlook in the minds of vapers advocating regulatory overhaul.
Meanwhile, FDA experts and insiders caution against getting carried away. Because regulations for vapor products ought to come from the FDA, regardless of a legislative agenda. The defense of vaping may be fueled in part by free-market-minded opposition to burdensome regulations, but it is also a public health crusade: Thus, vapor-products’ classification must derive foremost from the FDA’s science.
The FDA’s insulation from electoral politics serves to uphold its independent authority in matters of science. When elected officials intervene in FDA regulation, “It’s a slippery slope,” warned Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest and former Associate Commissioner for External Relations at the FDA. “Congress can pass law funding the FDA congress can pass laws asking the FDA to pursue certain directions but congress should not be passing laws telling the FDA on matters of regulatory science.”
Politicians who dig their grimy mitts too deep in the FDA’s regulatory policy may live to regret having set the precedent. “Even if it may create a law that you like for one product, it can create a law that you don’t like for another product.”
Vaping is generally understood to be a reduced-risk mode of nicotine delivery at least compared to sucking down combustible cigarettes—and, as such, vaping products are cast as a useful smoking cessation tool. Solid science, better than a president or member of Congress passing through, will guide FDA rules.
There’s also recourse within the FDA. The deeming rule was finalized in August, but a new FDA commissioner could kickstart the process of a rulemaking do-ever: “Given that the original deeming rule took over four years (it was authorized in the 2009 FSPTCA), it would probably take well into a Trump Administration second term to finalize that amended rule,” Daniel Carpenter, an FDA policy expert and Harvard government professor, told TWS.
In the meantime, lobbying to push the predicate date and dreaming up distinct vaping regulations will keep advocates within and without Congress occupied. And—fans of Philip Morris, take note—the imminent failure of these small vaping businesses remains a boon to Big Tobacco companies in much the same synergistic way that bootleggers and Baptists both benefitted from Prohibition.
Whether or not President Trump comes out in support of congressional efforts to combat the rules, the science of public health and the will of an unshackled market favor a robust vaping industry. In this is one instance, big government has an opportunity to protect Americans’ freedom to pick a less-deadly poison. The incoming administration, with its uncertain agenda, may yet wield even a subtle influence to stick up for the little guy—and encourage the FDA, bit by hyper-regulatory bit, to back down.
Corrections: An earlier version of this story incorrectly attributed a quote to George Conley. The quote came from Gregory Conley. Senator Johnson was not a co-sponsor of the Hunter’s proposed House rider, since he is a member of the Senate.
