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December 14, 2021

Califf Hearing Offers Few Clues to Future FDA Vape Regulation

Senators have described teen vaping over the last few years as an “epidemic,” a “crisis,” and an “emergency.” But today, with the opportunity to publicly pin down the man likely to deal with the issue as the next FDA commissioner, just one senator asked a question about e-cigarettes, and there was almost no discussion about tobacco policy issues at the agency.

The Washington Post ran a story this morning, before Robert Califf’s nomination hearing began, suggesting that many questions would be asked about the nominee’s positions on vaping and regulation of menthol and nicotine in cigarettes. But the senators did not oblige.

The lack of interest is especially notable considering the committee members with a history of opposition to vaping. Noted anti-vaping senators Mitt Romney, Patty Murray and Lisa Murkowski are all members of the Senate Health, Education, Labor & Pensions (HELP) Committee, which held the confirmation hearing for Califf, nominated by President Biden to lead the FDA.

With minor exceptions, the hearing was a cordial affair, with few disputes that might indicate problems getting the committee’s approval for the nominee. The last time Califf navigated confirmation, the process was more contentious, with strong opposition from several Democrats over his ties to the pharmaceutical industry. Today, Vermont Senator Bernie Sanders challenged Califf’s pharma connections and investments, but the exchange didn’t rise to the level of an argument.

In his opening statement, HELP Committee ranking member Richard Burr roasted the FDA Center for Tobacco Products for its slow and ineffectual rollout of vaping product regulations, citing the tobacco office’s sole vaping product authorization as an embarrassment to the FDA.

“More than a decade after receiving authority from Congress, FDA just recently issued the foundational rules to provide a regulatory roadmap for new, and potentially less harmful, tobacco products,” said Burr, referring to the FDA’s issuance of a final PMTA Rule a year after manufacturers were forced to submit applications. “Can you imagine if FDA did not have foundational regulations for the review of new drugs, while still requiring products to submit applications?” asked Burr.

“Despite 13 years and more than $7.5 billion [in tobacco company user fees], it has authorized under the premarket pathway only one vapor product—a class of product that can provide a new, potentially less harmful alternative for life-long smokers,” Burr noted. “CTP is charged with the regulation of tobacco products, which includes a mission to regulate these products for the protection of public health.

“It’s not meeting that mission either. According to data FDA gave me in 2019, CTP spent millions more on advertisements than it spent on enforcement actions to find bad actors. Dr. Califf, should you be confirmed, I would ask you to take a hard look at the tobacco center and get your house in order.”

The sole question on the topic of vaping or tobacco came from Wisconsin Sen. Tammy Baldwin, and the entire exchange (at minute mark 2:12:50 of the archived video) took just one minute.

“I know the FDA has been working overtime to evaluate a large number of e-cigarette Premarket Tobacco Applications, and I’m encouraged that the agency has set a high bar for flavored e-cigarettes to be authorized for sale in the U.S.,” said Baldwin. “But I’m concerned by reports that companies are taking advantage of loopholes in the law, and switching from making e-cigarettes to making flavored synthetic nicotine products. These products are increasingly popular, and they continue to be targeted to our nation’s children.

“As FDA commissioner, how would you work to address the rise in youth use of synthetic nicotine, and will you commit to working with Congress to ensure that the FDA has the authorities and resources it needs to crack down on these products?” Baldwin asked.

Responding, Califf first noted that CTP Director Mitch Zeller is retiring, and said that appointing “the right person” as Zeller’s successor is “absolutely one of the most important roles at the agency.”

“Secondly,” Califf continued, “this is not limited to children. I may have some family members using synthetic nicotine, I learned as I was going through the paces here. And what people don’t realize is that there are two enantiomers of nicotine—one of which is not occurring in nature—that are in this product, and its properties are not known.

“So we’ve got to close this loophole,” Califf added, “so that we make sure that we understand the risks and benefits, and particularly deal with the issues in children.”

Califf was referring to what are usually called R- and S-nicotine, stereoisomers that can be combined or used separately in synthetic nicotine. (Enantiomers are two chemical structures that are mirror images of each other.) Most research on nicotine is based on S-type nicotine extracted from tobacco. But it can also be synthesized, and R-type nicotine is only found in synthetic products. Many synthetic nicotine brands use what is called a racemic mixture of the two types.

But the chemistry of nicotine is inside baseball that doesn’t really interest Congress. Sen. Baldwin and other members of Congress are interested because the Campaign for Tobacco-Free Kids has announced that synthetic nicotine is a problem, and that makes it a problem for them.

Illinois Representative Raja Krishnamoorthi has already begun investigating synthetic nicotine, largely because disposable vape Puff Bar announced it would use synthetic nicotine to avoid FDA regulation and enforcement.

Presumably, the Senate committee members didn’t bother asking more vaping questions because they’re confident, based on Califf’s previous statements, that the nominee will be a reliable enemy of vaping and recreational nicotine use. Or because they were reassured in private meetings that Califf would oppose more liberal FDA regulation of vapes.

The HELP Committee will vote soon on whether to recommend Califf’s nomination to the full Senate. If the committee approves him, the former commissioner can expect full Senate confirmation to be the new commissioner soon, probably in January. Then we’ll get answers to the questions that weren’t asked today.

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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