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May 17, 2017

Gottlieb to FDA Staff: Smokers Deserve Low-Risk Products

In a speech to FDA staff on his first day as the agency’s leader, Dr. Scott Gottlieb nodded slightly toward vaping, even as he evoked the typical public health concern for “the children.”

Gottlieb told his new employees that patient and consumer protection is the fundamental mission of the agency, and that he believes in that mission. Then he touched briefly on many of the current challenges for FDA regulators.

“Among these and many other opportunities, there’s probably no single intervention, or product we’re likely to create in the near future that can have as profound an impact on reducing illness and death from disease as our ability to increase the rate of decline in smoking,” Gottlieb told the crowd.

“We need to redouble efforts to help more smokers become tobacco-free. And, we need to have the science base to explore the potential to move current smokers – unable or unwilling to quit – to less harmful products, if they can’t quit altogether. At all times, we must protect kids from the dangers of tobacco use.”

That was just what the vaping industry wanted to hear. But what exactly does it mean? We know that Gottlieb has previously written about the FDA’s opposition to tobacco harm reduction, and showed some understanding of the underlying issues that have pushed the agency to oppose the vaping market. But while encouraging smokers to become “tobacco-free,” is he throwing a bone to the anti-harm reduction ideologues at the FDA who have stymied efforts to tell the truth about snus and other smokeless tobacco products?

He also has owned stock in and served on the board of a vaping retail franchise. That connection earned him a lot of pointed questions about potential conflicts from Democratic senators during his confirmation hearing. The preemptive accusations may make him hesitant to take bold action to prevent the FDA from crushing the independent vapor market and handing it to the tobacco industry. And bold action is needed.

What could Gottlieb do?

new-direction with scott gottlieb fda

As most vapers know, the FDA’s deeming regulations will effectively put the industry out of business in November 2018, when all products that were not already on the market in February 2007 will be removed, unless they are approved for sale by the agency. (The deeming countdown has recently been delayed by three months, but it hasn’t been stopped.)

The new FDA commissioner could further postpone or suspend enforcement of the future deeming deadlines, which would allow more time to pursue relief through Congressional legislation, like the Cole-Bishop bill, HR 1136, or Rep. Duncan Hunter’s more comprehensive (but more challenging to pass) HR 2194.

He could also instruct the Center for Tobacco Products to amend the deeming rule by reinterpreting the 2007 predicate date, which the CTP has till now claimed impossible due to the wording of the 2009 Family Smoking Prevention and Tobacco Control Act, which mandates the older predicate. Many experts say the agency’s insistence on using the original TCA predicate date is disingenuous, and that the FDA has the flexibility to alter it.

But vapers have heard enough promises to hold their enthusiasm until they see actual results.

Another option would be for the FDA and Department of Justice to simply not defend the deeming regulations in court. There are six pending lawsuits in various federal courts around the country. The current administration could simply decline to defend the last administration’s ridiculous e-cigarette rule. That’s exactly what Jeff Stier and Henry Miller suggest in a new article in National Review.

“Attorney General Sessions, in consultation with Commissioner Gottlieb, can act right now by announcing the administration’s decision not to further defend the myriad cases,” they write. “Not only would doing so remove a politically charged issue from Gottlieb’s already very full plate, but it would help to restore the FDA’s credibility. It would also prevent DOJ from being forced to make untenable legal arguments.”

Committed supporters of Dr. Gottlieb seem convinced that he will take action to keep the independent vape market alive. But vapers have heard enough promises to hold their enthusiasm until they see actual results. What everyone agrees on is that action is needed soon.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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