FDA Crisis as Director Resigns to Join Philip Morris

Matthew Holman, Director of the Science Office at the Center for Tobacco Products (CTP) of the US Food and Drug Administration (FDA), is reportedly resigning in July to join Philip Morris International. His departure comes amid a crisis for the CTP, which has postponed decisions on the fate of hundreds of thousands of electronic cigarette products.

In September 2020, e-cigarette manufacturers were required to submit a Pre-Market Tobacco Product Application (PMTA) in order to continue offering their products for retail. In September of the following year, the FDA issued a ban on nearly one million flavored e-cigarette and e-liquid products, prompting many small-scale manufacturers, including all those active in the market since 2016, to switch from tobacco-derived nicotine to synthetic nicotine.

Lawmakers, who seem to act swiftly only on issues related to electronic cigarettes, have proposed and passed legislation allowing the FDA to regulate synthetic nicotine as a tobacco product. As a result, manufacturers of e-cigarette oils and other products must submit a new Pre-Market Tobacco Application (PMTA) by May 14, 2022 in order to sell their newly classified tobacco products.

Throughout the entire process, the FDA has faced pressure from members of Congress, so-called public health groups, and anti-vaping movements, to exert their administrative power and establish numerous standards, including prohibiting the use of flavorings and any level of nicotine content.

Throughout the PMTA process, one thing is certain: the agency overlooked the science. Now, it appears that the science has had enough and is stepping out to support a tobacco company that is more committed to reducing adult smoking rates than the FDA.

E-cigarettes and vaping devices are not the only products available for adult consumers looking to reduce tobacco harm. Smokeless tobacco, snus, and heated tobacco products offer alternatives that allow consumers to enjoy the benefits of nicotine without the harmful effects associated with tobacco combustion.

Although the FDA has been slow in approving pending applications, they have acknowledged that tobacco products carry continuous risks, with combustible cigarettes being the most harmful and nicotine replacement therapies posing the least amount of harm. After obtaining marketing authorization through PMTA (or other regulatory pathways), manufacturers can apply to modify modified risk tobacco product (MRTP) orders. So far, the FDA has only granted 14 MRTP orders.

Phimo International's heated tobacco product, IQOS, has obtained marketing and MRTP orders through the PMTA process. Unfortunately, due to patent disputes, US adult tobacco consumers are unable to purchase FDA-approved IQOS. However, Phimo International's new reduced-risk tobacco product is causing a rapid decline in smoking rates in other parts of the world.

In Japan, since 2016, heated tobacco products including IQOS have helped reduce cigarette sales by 42%. Furthermore, researchers from the American Cancer Society report that "the introduction of IQOS may reduce cigarette sales in Japan.

Although the FDA may recognize the potential of products such as IQOS to reduce tobacco harm, the agency still refuses to consider data on flavor use and enjoyment in electronic cigarette products among adults. Flavorings help adults quit smoking and maintain a non-smoking status.

The popularity of flavored e-cigarettes among adult users has been on the rise following the FDA's rejection of nearly one million flavored vaping products. Several surveys and studies have confirmed this trend.

For example, a survey conducted in 2018 of nearly 70,000 adult e-cigarette users in the United States found that "flavor plays a critical role in the use of e-cigarettes and e-cigarette devices", with 83.2% and 72.3% of respondents respectively indicating that they used fruit and dessert flavors. Additionally, a study in 2020 found a correlation between flavor and smoking cessation. In a cohort study of more than 17,900 participants, the authors found that "adults who started using non-tobacco-flavored e-cigarettes were more likely to quit smoking than those who used tobacco-flavored e-cigarettes.

Unfortunately, these studies do not appear to have swayed the FDA, which seems to have given in to the whims of lawmakers rather than examining the data, science, and absolute number of products to determine safer alternatives for adults.

Hallman left a company claiming to reduce smoking and joined PhiMo International, which highlights a potential theme: tobacco and e-cigarette companies are more committed to helping adults quit smoking than the FDA.

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