Regulating Novel Products

Governments worldwide are determining how to regulate novel products, including market access restrictions, taxes, public use, marketing, packaging, and product safety. New heat-not-burn products will require even further consideration.

E-cigarettes were originally designed to reduce smoking by replacing tobacco cigarettes, and there is limited but growing evidence that they are helping some smokers to transition away from combusted tobacco. The preponderance of available evidence suggests that using current-generation e-cigarettes is substantially less harmful than using tobacco cigarettes. However, there are lingering concerns about the harm from using e-cigarettes, particularly the uncertain long-term effects of nicotine use in the absence of combusted tobacco, and the interactions of heated e-liquid with sensitive lung tissue. There are also questions about whether e-cigarettes might pull ex-smokers back to using nicotine, and some argue that a causal “gateway effect” exists wherein youths begin to smoke tobacco cigarettes due to their exposure to e-cigarettes.

E-cigarettes present several regulatory challenges, and policymakers and governments continue to struggle with how to regulate them effectively. The most basic issue is whether these novel nicotine products should be given market access at all. At least 36 countries ban e-cigarette sales altogether, or permit device sales but ban the sale of nicotine e-liquid. This approach is understandable for nations with very low smoking prevalence where introducing a new nicotine product might undermine tobacco control efforts. Most governments are trying a variety of other approaches to gatekeeping market access, ranging from permissive (e.g. similar to existing tobacco products) to more restrictive (e.g. requiring authorization from health authorities before entry into the market and on an ongoing basis).

Beyond market access, there are several other policies to consider. First, should existing tobacco cigarette regulations— e.g. excise taxes, public use bans, and marketing restrictions —be applied to e-cigarettes, and to what degree? Consider that many e-cigarette advertisements are blatantly directed at youth, recalling cigarette ads in the recent past. Also, many countries have product safety regulations pertaining to e-liquid contents, child-safe packaging, nicotine quality and concentration, flavors, and other ingredients.

Lastly, policymakers will need to consider what regulations should apply to “heat-not-burn” products that heat processed tobacco in a controlled fashion rather than combusting it. They are likely to be more harmful than e-cigarettes because they contain tobacco, and the early evidence shows that they contain considerably higher levels of toxins than do e-cigarettes. There will not be much time to decide: heat-not-burn is already rapidly gaining market share in Japan, and has been introduced in more than 25 countries.

Market Access Map

There is wide variety in market access to e-cigarettes across the world.

Extension of Tobacco Control Policies

Slick Retailing

Philip Morris is marketing their novel IQOS product in highly stylized stores with eager customer service representatives, resembling Apple Stores.


Photo Credit: IQOS store T. Johnston


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Kennedy, Ryan David, Ayodeji Awopegba, Elaine De León, and Joanna E. Cohen. 2017. “Global Approaches to Regulating Electronic Cigarettes.” Tobacco Control 26 (4): 440–45. doi:10.1136/tobaccocontrol-2016-053179.

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