During the “Toxicological Profile” session at FDA’s Feb 10 PMTA roundtable, officials outlined the carcinogenicity tiering system and Excess Lifetime Cancer Risk (ELCR) framework used in ENDS reviews under the APPH standard. Small manufacturers questioned database transparency, exposure assumptions, and the existence of clear compliance benchmarks. FDA reiterated toxicological risk is assessed case by case within a broader population-level determination.

During the FDA PMTA roundtable session on “Studies of Adult Benefit,” officials said flavored ENDS must demonstrate “added benefit” over tobacco-flavored products under the APPH standard, including sustained complete switching evidence. Small manufacturers questioned switching benchmarks, study duration, and bridging expectations.

At the third session of its PMTA roundtable, the FDA outlined its framework for assessing abuse liability in ENDS products, emphasizing the role of nicotine pharmacokinetics and product-specific data in APPH determinations. Small manufacturers questioned the high cost of clinical PK studies and the absence of defined numeric thresholds, while raising bridging strategies and PBPK modeling as potential alternatives.

The Tobacco Board, under the administrative control of India’s Department of Commerce, has written to Finance Minister Nirmala Sitharaman (Nirmala Sitharaman) flagging the adverse impact of an “unprecedented” increase in cigarette excise duties on the industry and on millions of farmers and workers, and urging a revision of duty rates.

Police said detections of new drugs disguised as e-cigarettes reached 1,206 cases through September last year, up from 941 in 2022, and the number of detected drug types increased from 26 to 33 over the same period.