- - Tuesday, March 19, 2019

ANALYSIS/OPINION:

Scott Gottlieb’s resignation as commissioner of the U.S. Food and Drug Administration comes at just the right time. Unlike other Trump regulatory agency appointees who understood their mandate was to lighten the burden on business, he insisted on adding to it.

Maybe you can’t run the FDA without becoming an avenging angel for the Nanny state, bent on protecting people from themselves and limiting their choices even where life and death are concerned. Who knows? What we do know is that his September 2018 declaration of war against e-cigarettes threatens to waste a significant and important opportunity to improve the health of a lot of people.

Before he was appointed commissioner of the FDA, and even early in his tenure, Mr. Gottlieb was on the record as a supporter of vaping. “At face value,” he said only two months ago, “we believe these [vapor] products pose less risk than combusting tobacco. If you can fully switch every currently addicted adult smoker who is using combustible tobacco products onto e-cigarettes, you will have a profound impact on public health. And some people can switch completely. We think that is a public health benefit.”

Reliable estimates are that nearly a million American adults who are addicted to cigarettes have not been able to quit even though they have tried everything from patches to hypnotism, and found relief with electronic substitutes. Yet instead of promoting these substitutes, which could save lives and millions of tax dollars, Mr. Gottlieb and the FDA decided vaping should be regulated, like smoking.

Following conversations with the five biggest vapor and tobacco companies, Mr. Gottlieb announced a proposal to curb youth access to vaping. Under his plan, all flavored substitutes, except for menthol and mint flavors, must be available only to those 18 and older in a vape shop or in an age-restricted section of a store or shop.



In addition, all online sales of flavored substitutes must be subject to age verification and all such products marketed “using popular children’s cartoon or animated characters, or names of products favored by kids like brands of candy or soda” could be banned.

Mr. Gottlieb makes several assumptions in pushing for these new regulations. He assumes that flavored products are preferred by young vapers and ignored by adults; that adult smokers will migrate from the convenience stores where they buy cigarettes to dedicated vapor shops; that vapor shops would do a better job of restricting youth purchases than convenience stores and gasoline stations. These assumptions are not proven.

The Trump administration has been praised by conservatives for its focus on science-based regulation. So why is the FDA pushing a big government regulation that ignores the data here? Mr. Gottlieb’s proposed rules — some call them his parting gift to trial lawyers — amount to setting up the vaping industry for tobacco-style lawsuits. If the new leadership at FDA doesn’t pull them back then the Office of Information and Regulatory Affairs inside the White House Office of Management and Budget, now led by acting director Russ Vought, a solid conservative and free marketer, should.

If they’re allowed to go into effect, these new rules will discourage adult smokers from trying vaping to quit cigarettes. They will also punish gasoline stations, convenience stores and other retailers by making vapor sales cost-prohibitive, moving that revenue to underregulated vapor-specialty shops. Smokers who might otherwise make the switch from traditional cigarettes to flavored vapor might not seek out the dedicated vape shops. Those who have already migrated from cigarettes to flavored vapor might even, just for convenience sake, even knowing it would ultimately be bad for their health, return to authentic coffin nails.

The Gottlieb rules are bad public policy. They will harm public health by restricting access to proven smoking substitutes, impose burdens on retailers selling something the public wants and drive youthful vapers to underregulated vape shops where they will be exposed to a much wider variety of temptations.

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