On February 15, the Senate confirmed cardiologist Robert M. Califf, M.D., to lead the U.S. Food and Drug Administration (FDA). He’s no stranger to the agency. Dr. Califf served a brief stint as FDA’s commissioner of food and drugs from February 2016 to January 2017, and before that, he was deputy commissioner for medical products and tobacco from February 2015 until February 2016. So what might his appointment mean for the tobacco industry? We have five takeaways.
1. Expect the agency to continue a hard line on flavors.
In a 2019 opinion piece posted on the Association of American Medical Colleges (AAMC) website, Dr. Califf suggested FDA immediately ban all flavors in vaping products, also known as electronic nicotine delivery systems (ENDS) devices, citing their appeal to youths.
This tough stance on flavored tobacco products would not mark a dramatic shift at FDA.
The agency is currently reviewing premarket authorization applications for ENDS devices to see whether such products can continue to be sold. To date, FDA has ruled on 99% of those applications, but only authorized the marketing of one ENDS device and two-related tobacco-flavored cartridges so far. By contrast, the agency has issued marketing denial orders for over 946,000 flavored ENDS products “because their applications lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health thread posed by the well-documented, alarming levels of youth use of such products.” Many of these denials are being challenged in court, and FDA has not yet ruled on applications from some of the largest manufacturers.
Meanwhile, FDA is expected to issue proposed standards banning menthol in cigarettes — the last allowable characterizing flavor in cigarettes — and banning all flavors in cigars by April 2022. Although the public does not yet have specifics, the proposals were recently submitted to the Office of Management and Budget to assess their effect on the U.S. economy — a sign they are on track for publication soon.
2. Preventing youth access to ENDS devices will remain a high priority at FDA.
Among unauthorized ENDS products, FDA currently prioritizes enforcement against flavored ENDS, manufacturers that have failed to take adequate measures to prevent underage access, and ENDS products marketed toward underage users.
These enforcement priorities are unlikely to change with Dr. Califf at the helm. In the 2019 AAMC article, Dr. Califf urged strict enforcement of the premarket review requirements for ENDS devices, as well as called for increased surveillance to curtail unlawful sales of such products to minors. Preventing youth access to e-cigarettes also made his list of priorities in a February 17 memo to FDA staff.
One question is whether Dr. Califf will prioritize enforcement against other deemed products that are unlawfully marketed. To date, the agency’s efforts in this regard have focused on relatively clear violations, such as companies that continue to market products subject to marketing denial orders. And the agency’s actions have generally been limited to warning letters. It remains to be seen whether the agency will take more diligent and aggressive enforcement action against products that lack marketing authorization or have not timely submitted a request for marketing authorization.
3. Dr. Califf has proposed banning over-the-counter vaping products and requiring a prescription to purchase ENDS devices, but this seems unlikely today.
In describing his ideal regulatory regime for ENDS devices, Dr. Califf advocated for a ban of over-the-counter vaping products, while allowing adult smokers to obtain a prescription to avoid withdrawal symptoms.
A ban of over-the-counter sales of all ENDS devices, however, seems unlikely. FDA has already authorized its first ENDS device and tobacco-flavored cartridges for sale in the U.S. in light of their potential benefit to adult smokers who switch to the products. Moreover, Dr. Califf himself acknowledged that “[o]utright prohibition of vaping products seems impractical on several grounds,” citing, among other things, Americans’ belief in personal freedom and the possible unintended consequence of stimulating a harmful black market.
That said, it is conceivable that FDA could one day approve the right ENDS device as a smoking cessation aid, as it has done for nicotine replacement therapies and drugs. Indeed, the United Kingdom (U.K.) is headed in that direction. Last fall, the U.K.’s Medicines and Healthcare Products Regulatory Agency invited manufactures to submit applications for medical licenses for e-cigarettes to give clinicians the ability decide on a case-by-case basis whether prescribing the product might help a patient quit smoking.
Alternatively, with the right clinical evidence, FDA could authorize an ENDS device to be marketed as a modified risk tobacco product “for use to reduce harm or the risk of tobacco-related disease,” as it has done for other products, including a heat-not-burn cigarette, low-nicotine cigarettes, and two smokeless tobacco products.
4. In coming years, FDA may seek to cap nicotine levels in tobacco products.
Dr. Califf has also advocated for lowering the amount of nicotine in tobacco products to “subaddictive levels,” which is not a new idea at FDA. In July 2017, FDA announced a “Comprehensive Plan for Tobacco and Nicotine Regulation,” which included an effort to seek evidence and public input on whether the agency should lower nicotine in cigarettes “to a minimally or non-addictive level through the creation of a potential nicotine product standard.” Indeed, FDA issued an advance notice of proposed rulemaking in March 2018 to explore such a standard. Although the plan was shelved in 2019, the White House has expressed interest in reviving it. Notably, this rulemaking process would likely take several years, and any rule will be subject to legal challenges.
5. Lastly, FDA is poised to regulate synthetic nicotine products.
During a Senate committee hearing to consider his nomination, Senator Tammy Baldwin asked Dr. Califf what he would do to “crack down” on companies switching to flavored, synthetic nicotine products to avoid FDA premarket authorization requirements to which he responded, “We’ve got to close this loophole, so that we make sure that we understand the risks and benefits and particularly deal with the issues [facing] children.”
As our team reported, Congress recently passed a bill giving FDA the express authority to regulate synthetic nicotine, so Dr. Califf is poised to lead this effort.
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