Flashpoints in Tobacco Markets in Times of the COVID-19: Marketing Authorization for IQOS by FDA and Artificial Intelligence31 July, 2020
The United States (“US”) Food and Drug Administration (“FDA”) took action regarding tobacco market in the US including authorizing marketing of IQOS Tobacco Heating System with “reduced exposure” information and issuing warning letters to several companies to remove their flavored disposable e-cigarettes and e-liquid products. Meanwhile the World Health Organization (“WHO”) announced new virtual health worker to quit tobacco explaining that quitting smoking is more important than ever as evidence reveals that smokers are more vulnerable to developing a severe case of COVID-19 and published a statement regarding current FDA decision.
FDA Authorized Marketing of IQOS Tobacco Heating System with “Reduced Exposure” Information
The FDA authorized the marketing of a heated tobacco product, the IQOS Tobacco Heating System, under the Federal Food, Drug and Cosmetic Act (“FD&C Act”) on July 7, 2020. On August 8, 2016, the FDA’s authority was extended to all tobacco products with a deeming rule. The FD&C Act requires pre-market authorization of new tobacco products before they can be placed on the US market. By law, the FDA must ensure that the advertising and labeling of modified risk tobacco products (“MRTP”) enables the public to understand the modified risk or modified exposure information and to understand the significance that information has in the context of total health and in relation to all tobacco-related diseases and health conditions.
There are two types of MRTP orders the FDA may issue: i) a “risk modification” order or ii) an “exposure modification” order. Regarding the IQOS Tobacco Heating System, the FDA determined that the evidence did not support issuing a risk modification order at this time and issued exposure modification order. The FDA noted that, “Even with this action, these products are not safe nor “FDA approved“. The exposure modification orders do not permit the company to make any other modified risk claims or any express or implied statements that convey or could mislead consumers into believing that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers.” The authorization for these products requires the company to conduct post-market surveillance and studies to determine whether the MRTP orders continues to be appropriate, including assessing the potential for increased use among youth.
FDA Notified to Remove Flavored Disposable E-Cigarettes and E-Liquids from Market
Further, the FDA announced on July 20, 2020 that warning letters were issued notifying ten companies to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization. These firms were cited for marketing unauthorized e-liquids that imitate packaging for food products that often are marketed and appeal to youth, or feature cartoon characters. Failure to correct violations may result in further action such as a civil money penalty complaint, seizure or injunction. In addition, misbranded or adulterated products imported into the US are subject to detention and refusal of admission.
WHO Reminded Member States Their Obligations Regarding Tobacco Products
With this regard, on July 27, 2020, the WHO published a statement regarding heated tobacco products and the FDA decision regarding IQOS Tobacco Heating System to remind WHO member states that are parties to the WHO Framework Convention of Tobacco Control (“FCTC”) of their obligations.
The WHO explained that heated tobacco products are tobacco products, therefore the FCTC fully applies to these products. Accordingly, parties are obliged to prohibit "all forms of tobacco advertising, promotion and sponsorship that promote a tobacco product by any means that are false, misleading or deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions." In addition, the WHO stated that mentioned FDA orders grant a temporary market authorization within the US and are based on factors specific to the US, which is not a party to the FCTC.
WHO Introduced AI Health Worker to Help Quit Tobacco
The WHO's first virtual health worker, designed to help the world's 1.3 billion tobacco users quit was announced on WHO website on July 7, 2020. It has been announced that the virtual health worker (Florence) uses artificial intelligence to dispel myths around COVID-19 and smoking and helps people develop a personalized plan to quit tobacco.