FDA Nicotine Ruling Sparks Call for India to Review Tobacco Science

FDA's ruling on Nicotine raises case for India to commission its own scientific appraisal; Experts back ICMR-led review

New Delhi, July 22

For India, the pivotal question is whether the country's research institutions are willing to conduct an independent analysis of this emerging data, adapted to its own setting.

Findings are accumulating from nations that have adopted different oversight models. Sweden, the United Kingdom, Japan and Norway have documented drops in cigarette smoking alongside the uptake of non-combustible alternatives.

The United States permits modified-risk claims following FDA evaluation. None of these frameworks should be transplanted wholesale. Collectively, however, they constitute a body of research that warrants dispassionate review by domestic scientists -- neither dismissed on ideological grounds nor embraced uncritically.

The Indian Council of Medical Research (ICMR) is the country's apex biomedical research body and the government's key scientific advisor on health. For over a century, its assessments have guided national policy on everything from infectious disease control to clinical research standards. With its institutional credibility, ICMR is best placed to lead an objective appraisal of emerging tobacco and nicotine data.

Padma Shri Awardee, Dr. Mohsin Wali, Senior Consultant at Sir Ganga Ram Hospital, New Delhi says, "India has a track record of scrutinising global evidence critically and tailoring it to domestic priorities. ICMR exemplifies this pragmatic approach: in COVID-19 diagnostic validation, gene therapy development and clinical trials, and Good Clinical Practice, it has aligned its structures with internationally accepted benchmarks, including those of the U.S. FDA and ICH. This method enabled India to adopt proven technical practices while calibrating them to the national context. A similar assessment of the U.S. trajectory in tobacco governance is now worth pursuing. Over several decades, cigarette smoking and overall tobacco consumption have declined substantially in the United States, while India continues to face a large and, in some segments, growing challenge. Studying that divergence could inform strategies suited to India's distinct landscape."

India carries one of the world's largest tobacco burdens, with nearly 267 million users. Tobacco-related illness remains a leading cause of cancer, cardiovascular and respiratory disease. Preventing initiation and supporting complete cessation must remain the cornerstone of tobacco control. Yet millions of adult consumers are unable to quit despite repeated attempts. That is where an evidence-based conversation on options for grown users becomes necessary.

Padma Shri Awardee, Dr. Chandrakant S. Pandav Former Professor & Head of the Department - Centre for Community Medicine at the All India Institute of Medical Sciences (AIIMS New Delhi) says, "The strongest objection is that such a discussion will spur youth uptake. U.S. figures counter that concern. The record shows that as the FDA authorised modified-risk claims for adults, overall youth tobacco use fell from 23.3% in 2019 to 7.5% in 2025 -- the third consecutive annual decline. Youth e-cigarette consumption dropped to 5.2%, its lowest in a decade. Cigarette smoking among teenagers stands at 1.4%, and use of oral products, the category authorised for adults, was 1.7%. Calibrated governance combined with sustained public health messaging can curb youth uptake while pathways for grown users away from combustible tobacco are evaluated. Protecting young people and providing alternatives for adult consumers are not incompatible goals. Calling for an independent scientific review does not mean adopting another nation's policies, endorsing any product, or weakening India's tobacco control framework. It means enabling Indian researchers to examine the data rigorously its strengths, limitations, long-term outcomes and population-level effects and determine what relevance, if any, it holds within India's epidemiological and regulatory environment."

Science has long underpinned sound public health policy in the country. It guided the COVID-19 response, strengthened clinical research standards, and shaped vaccine development. Strategies for tobacco and nicotine consumption deserve the same rigour. The question is not whether the country should mirror the FDA. It is whether the country will apply the same independent scrutiny to emerging findings that has shaped much of its healthcare policy.

Given the scale of India's tobacco epidemic, the answer should be driven by evidence both global and local for the benefit of Indian public health not by ideology, as the cost of lives lost each year is never recoverable.

— ANI