The U.S. Food & Drug Administration (FDA) has appointed Cristine Delveno to the position of Chair of the Tobacco Products Scientific Advisory Committee (TPSAC). Delnevo was previously appointed to the committee in March 2021.
Delnevo is set to hold the position for four years, starting immediately and ending at the beginning of 2025.
“I have valued the importance of this FDA advisory committee since the signing of the Family Smoking Prevention and Tobacco Control Act in 2009. This advisory committee plays an important role in several ways, perhaps most notably on the review of modified risk tobacco product applications, as required under the Tobacco Control Act,” said Delnevo.
“I value the service of Dr. Jonathan Samet and Dr. Robin Mermelstein who served admirably before me as chair, and I look forward to working with an esteemed group of colleagues to help the FDA make regulatory decisions to protect public health and reduce tobacco-related morbidity and mortality.”
The appointment came as a response to Dr. Jonathan Samet and Dr. Robin Mermelstein leaving the committee.
Who is Cristine Delnevo?
Cristine Delnevo boasts an extensive career both as a regulator and academic in the context of the tobacco industry.
Prior to this latest appointment, Delnevo was the director of Rutgers Center for Tobacco Studies, as well as a professor of Health Behavior, Society, and Policy at the Rutgers School of Public Health. She has amassed over 22 years of experience in this field throughout her career.
Delnevo has also been a part of a number of publications with a focus on vaping during her time in academia. Currently, she has authored over 250 scientific articles and reports on tobacco control.
According to a statement by Rutgers, Delnevo focuses on non-cigarette tobacco products like vapes and e-cigarettes. She has also focused largely on tobacco control policy and regulation.
It is unclear whether Delnevo prescribes to the known information proving that vaping could be a vital tool in tobacco harm reduction at this point. However, her past experience and areas of expertise mean that there is a good chance she will be able to bring positive change to the vaping regulations set by the FDA.
One aspect of Delveno’s appointment that could cause issues for the vaping community is her work around cigar flavoring. The FDA has cited a large amount of her work regarding two proposed cigar flavoring bans, including menthol.
Amidst all of the flavor bans across the U.S., this could only worsen the situation. The flavor ban approach the FDA and many states has adopted, while seemingly sound, runs the risk of undoing a large amount of the beneficial work that vaping has done for smoking cessation.
The Role of the Tobacco Products Scientific Advisory Committee
The TPSAC was established in 2009 to aid in the agency’s scientific review process of tobacco products.
The role of the TPSAC is to conduct the process of evaluations and reviews regarding the health risks of tobacco products. This information is then used to inform decisions to the commissioner of the FDA and make recommendations on a large variety of tobacco-based products, including vaping.
There has been somewhat of a divide between this relationship within the agency in recent times, particularly with vaping regulations.
An apparent lack of scientific backing has made its way into nearly all regulatory decision-making. Many have pointed out the arbitrary choices behind the marketing orders issued to countless vaping manufacturers since the PMTA process began.
FDA Restructuring in Recent Times For the Better?
There have been some major changes in the FDA’s tobacco departments in recent times, and it is unclear the effect Delnevo’s appointment will have on the FDA’s regulatory approach to vaping. However, other changes have shown clear signs of trouble within the agency.
Brian King was appointed as the director of the agency’s Center for Tobacco Products (CTP). In response to King’s poor history with vaping, many in the community believe this development will only worsen the relationship between vaping companies and the FDA.
Another change that left the vaping community concerned was Matthew Holman’s abrupt leave from the CTP branch of the agency.
“Dr. Holman is not leaving the FDA, he’s escaping,” Amanda Wheeler, the President of American Vapor Manufacturers, told Filter. “It is hard to avoid the sense that the most serious and essential work on tobacco harm reduction is being done outside of an agency that appears beyond repair.”
Holmann left the agency and stated that he “recused himself, consistent with agency ethics and policies, from all CTP/FDA work while exploring career opportunities outside of government.”
Since then, Holmann is now employed by Philip Morris International, one of the largest tobacco companies in the world.
This rapid departure by Holmann should be seen as a clear indicator that things are not running well within the agency, and many believe this can be seen in the nightmare that the premarket tobacco application process has become.
The Food & Drug Administration has appointed Cristine Delnevo as chair of the Tobacco Products Scientific Advisory Committee. Delnevo will serve a four-year term in this new position.
With any luck, Delnevo’s extensive experience will be utilized to inform proper decision making within the agency amidst a string of baffling choices made in recent times. However, there is the potential that other changes within the agency’s structure, like the appointment of Brian King, are a sign of only worse outcomes.