By Amit Narang
November 14, 2019 at 5:00 am ET
Here’s the cost of not regulating e-cigarettes: more than 2,000 injured and 39 dead, most of them under age 35.
Shockingly, these lives and the health of about 5 million middle-school and high-school students now addicted to vaping didn’t matter as much to corporate-captured regulators as keeping vape shops and e-cigarettes profitable.
We need a regulatory system that protects the public — especially children — before people get sick and start dying. The vaping crisis is what happens when corporate lobbyists and ideological extremists have too much influence over the regulatory process and when regulators rely too heavily on cost-benefit analysis. Waiting for kids to become lifelong addicts, get sick and die to justify the benefits of regulating is exactly what happens when cost-benefit analysis drives decisionmaking at regulatory agencies.
Back in 2016, the government had a chance to nip the vaping crisis in the bud, before it ballooned into a full-blown epidemic. In fact, that’s exactly what the Food and Drug Administration intended to do by imposing a ban on flavored e-cigarettes, as part of a broader “deeming” rule that extended the FDA’s authority to regulate tobacco products and e-cigarettes.
But that’s when the FDA’s proposed ban arrived at the U.S. Office of Information and Regulatory Affairs, the last stop in the rulemaking process before a proposed regulation is finalized. OIRA has long been criticized for weakening or blocking regulations on the grounds that those regulations are too costly, while ignoring or downplaying the benefits of those regulations in terms of protecting the public.
Instead of listening to government scientists and public health experts, OIRA officials took their marching orders from a small fleet of tobacco and vaping industry lobbyists, who got 94 meetings with agency officials on the deeming rule while it was under OIRA review. That may be the most meetings OIRA has held on any rule it ever has reviewed.
The result of those meetings: More than 15 pages of evidence detailing the role flavors played in the youth vaping upsurge were deleted from the analysis in the final rule. Also gone: the flavored vaping ban.
The former officials who made the decision to block the FDA ban now say they did it because the benefits of the ban were “inconclusive” at the time. In other words, not enough people had become addicted, gotten sick or died from e-cigarettes to justify the ban.
Now, three years later and facing a rising body count, the FDA once again is trying to ban flavored vapes. Only this time, the FDA plans to do it through regulatory guidance, rather than a full rulemaking that could take years to complete and would be implemented far too late, given that the vaping crisis already is spiraling out of control.
As part of its 2016 deeming rule, the FDA set up a pre-market approval process that would be required for all flavored vapes. But since virtually all flavored vapes already on the market haven’t gone through this process, the FDA issued guidance giving itself discretion not to take enforcement action against them.
Now, the FDA plans to issue new guidance. Going forward, all flavored vaping products will have to be targeted for enforcement, since none of them received the agency’s pre-market approval.
There’s just one problem: President Donald Trump’s recent executive orders attacking regulatory guidance are likely to get in the way. One of the executive orders says agencies cannot use guidance to prohibit conduct.
It’s a legal fiction to claim that agencies use guidance to prohibit conduct, since guidance only interprets regulations and laws that themselves prohibit conduct. But conservative groups opposed to the flavored vape ban, most of which support Trump’s executive orders on guidance, are pointing to those executive orders as grounds for blocking the ban.
We need our government to prevent public health crises before they start, not react to them after it’s already too late. In order to do that, we need broad, structural reforms to end the corporate capture of our regulatory process, which allows big business undue influence over our watchdogs in government. Health, safety and environmental concerns must come before corporate profits and anti-government ideology — especially when lives are on the line.
When regulators listen to corporate interests and the anti-regulatory ideologues on the right instead of doing what’s right, our kids pay the price.
Amit Narang is the regulatory policy advocate for Public Citizen.
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