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VIEW: The US FDA signals a new path for smokeless tobacco

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The Indian Government must reassess its stance on smokeless tobacco products, and commence scientific analysis suitable for the Indian scenario, in light of potential benefits for existing smokers who make the switch.

VIEW: The US FDA signals a new path for smokeless tobacco
Not all tobacco products are created equal. Indeed, the use of any tobacco product represents a health risk, i.e., no product is harmless. Further, the purpose is the intake of nicotine, which is addictive. However, within this class of products, there exists a clear risk-spectrum. Certain products can reduce the user’s exposure to some harmful substances, compared to other products.
The U.S. Food and Drug Administration (FDA) has explicitly recognised this fact by permitting the tobacco giant Philip Morris to market its “IQOS Tobacco Heating System” as a ‘modified risk tobacco product’ with “exposure modification” orders. According to an FDA press release early last month announcing the orders, while this does not mean that the product is “FDA approved”, it permits the marketing of the product as “demonstrably reducing the user’s exposure to particular harmful substances, compared to other products”.
The press release further states, that the FDA determined that because the product heats tobacco but does not burn it, it significantly reduces the body’s exposure to 15 specific harmful and potentially harmful chemicals compared to cigarette smoke. These chemicals include carcinogens and toxins that can harm the respiratory or reproductive systems.
The above findings are not at all new, or even unknown to regulators worldwide. The FDA action, however, does provide a stamp of approval, backed by detailed scientific analysis, in-depth research, and studies over several years. This development reinforces earlier conclusions reached by regulators, leading public health institutions and scientific bodies across global markets such as the UK, Germany, and the Netherlands. The UK, for example, has based its entire policy around this analysis, where the government suggests smokers who do not or cannot quit, should consider switching to these reduced harm products.
It is worth noting, the key reason for resistance to smokeless tobacco products has not been that they were perceived to be excessively harmful. Instead, it has been regulators’ apprehension that these products will undermine years of anti-tobacco efforts, and declining rates of smoking worldwide. They fear that users will be lulled into believing that they can eat their cake and have it too.
Consumers, particularly children, may see such products as harmless, or not as bad as smoking, and take them up without factoring in the consequences. This was one of the Indian government’s key stated reasons while introducing and passing the Prohibition of Electronic Cigarettes Act, 2019 (E-cigarettes Prohibition Act) imposing a blanket ban on commercial activities such as manufacturing, import, sale, and advertising of electronic cigarettes.
The FDA action addresses this concern in the most direct and balanced manner. The action requires Philip Morris to conduct postmarket surveillance and studies, including rigorous toxicity studies, to assess consumer perception, behavior, and health, to enable the FDA to review its determination. Philip Morris is also required to monitor youth awareness and use of the products to prevent unintended consequences of youth use and is obliged to keep the FDA apprised of efforts to prevent youth access and exposure.
The above approach is the epitome of data-driven and balanced policymaking, keeping in mind competing interests and concerns. The adoption of this approach presents a huge public health opportunity for India. Proper implementation can result in maximising use among adult smokers who cannot or do not wish to quit smoking, encouraging them to switch completely, while ensuring very limited or no youth uptake. For example, joining governments around the world such as Japan, Korea, the US, Canada and the UK, the Hong Kong Legislative Council recently decided to terminate discussions and walk back a proposed ban on electronic cigarettes, in part, based on emerging evidence.
Next Steps for India
The good news is that the Indian Government has a window to explore this path while retaining the ban imposed by the E-cigarettes Prohibition Act. The E-cigarettes Prohibition Act does not restrict research and analysis and does not ban any product which is licensed under the Drugs and Cosmetics Act, 1940 (Drugs Act). Other similar products licensed under the Drugs Act include chewing-gum and lozenges containing nicotine.
While electronic cigarettes are not ‘drugs’, as observed by the Delhi High Court last year, certain variants may qualify. The UK recognises that smokeless tobacco products are generally consumer goods, but certain strengths and formulations may apply to be categorised as medical devices to help people quit smoking. India may not elect to go down that path. However, since there may be an upfront reluctance to amend or change the E-cigarettes Prohibition Act on grounds of political pragmatism, the Drugs Act does provide the Indian Government with a route to commission and carry out much-needed research.
Thus, the foremost option for the Indian government is to use the regime of the Drugs Act, to begin reviewing smokeless tobacco products, including conducting transparent and collaborative hearings. The relevant ministries must engage with the reams of scientific data and carry out independent scientific research suitable to the Indian context. Armed with such research, the Indian government can make informed and balanced policy decisions, including where appropriate, suitably amending the E-cigarettes Prohibition Act.
Further, the lesson from FDA’s inclusive and transparent scientific review process is that corporations and industry participants have an important role to play, in particular through continued research and development, as well as by generating data through monitored implementation. The FDA’s action is a welcome development and a reminder for governments like ours to continually reevaluate decisions as new data and research emerges, and to be open to changing its mind in light of such data. The Indian Government must reassess its stance on smokeless tobacco products, and commence scientific analysis suitable for the Indian scenario, in light of potential benefits for existing smokers who make the switch.
—The authors—Upendra Sharma and Rishabh Gupta—are partners with JSA. The views expressed are their own

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