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Pulmonary toxicological evaluation and chemical interactions of menthol, mint, and tobacco flavored e-cigarette products

Award Number: R00ES033835
ORGANIZATION: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/19/2023
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Pulmonary toxicological evaluation and chemical interactions of menthol, mint, and tobacco flavored e-cigarette products - PROJECT SUMMARY (See instructions): Menthol, cooling/ice, and tobacco flavors are among the most abundant for Electronic Nicotine Delivery Systems (ENDS) or electronic cigarettes. These flavors are not regulated due to the potential public health benefit cessation of combustible tobacco use. However, the toxicological effects of vaping these products are not entirely understood. Further, increased use of cooling/ice/menthol-like products is correlated with higher e-cig consumption due to their cooling and antitussive properties. However, the modified risk and toxicity of these products are poorly understood. The K99 /R00 proposal aimed at identifying the chemical agents (flavoring chemicals) that cause lung toxicity using cell culture and mouse models. As the K99 phase provided biologically significant data from acute exposures, we will continue the same aims as below with a modified R00 plan mainly focusing on sub-chronic (in vitro) and chronic (in vivo) exposures mentioned in Aims 2 and 3. The R00 phase will focus on validating the toxicants identified in the aerosols and relating them to the biological response and biomarkers. Moreover, these findings will be validating during prolonged exposures to flavored ENDS and chemical agents. This study hypothesizes that menthol/cooling flavors and tobacco flavors contain harmful chemicals that induce adverse cellular and biological responses and chemically interact upon aerosolization, causing augmented toxicity with preexisting respiratory conditions. Aim 1: Identify the chemistry of menthol, menthol-like (cooling), and tobacco flavors, including flavoring chemicals and secondary products formed upon aerosolization. Aim 2: Determine in vitro and in vivo toxicity and health effects of menthol, menthol-like (cooling), and tobaccoflavored ENDS in EpiAirway 3D tissues and mice (C57BL/6J and BALB/C) under normal and pre-existing respiratory conditions. Aim 3: Determine in vitro and in vivo toxicity and health effects of menthol, menthollike (cooling), and tobacco flavoring chemicals in EpiAirway 3D tissues and mice (C57BL/6J and BALB/C) under normal and pre-existing respiratory conditions. In R00 phase, effects in lung after sub chronic and chronic exposure to CS and then switching over to ENDS (menthol, cooling, and tobacco) will also be determined, allowing to assess the benefit or the modified toxicity of switching from CS to ENDS. This will further be studied in normal, asthma, and COPD, 3D tissues (sub chronic) and mice with the same phenotypes. Thus, Dr. Muthumalage, in his R00 proposes to perform a comparative toxicity, and biomarkers of disease under normal and pre-existing respiratory disease conditions providing information necessary for regulation of harmful constituents in these products.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE # 1100	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	5	1/13/2026	NON-COMPETING CONTINUATION	$0
2026	2025	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE # 1100	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	5	8/12/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $249,000 )
2025	2025	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE # 1100	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	5	8/15/2025	NON-COMPETING CONTINUATION	$249,000
														Subtotal = $249,000

Issue Date FY: 2024 ( Subtotal = $249,976 )
2024	2024	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE # 1100	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	003	4	8/12/2024	NON-COMPETING CONTINUATION	$249,000
2024	2023	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE # 1100	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	3	5/29/2024	EXTENSION WITH OR WITHOUT FUNDS	$976
2024	2023	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE STE 1900	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	3	12/13/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
2024	2023	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE STE 1900	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	10/13/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $249,976

Issue Date FY: 2023 ( Subtotal = $249,000 )
2023	2023	PURDUE UNIVERSITY	2550 NORTHWESTERN AVE STE 1900	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	9/18/2023	EXTENSION WITH OR WITHOUT FUNDS	$249,000
														Subtotal = $249,000

Grand Total All Awards = $747,976

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Pulmonary toxicological evaluation and chemical interactions of menthol, mint, and tobacco flavored e-cigarette products

Award Number: R00ES033835

ORGANIZATION: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/19/2023

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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