Lindsey Stroud | The FDA has a science problem — literally | Guest Comment


It was announced in July that Matthew Holman, director of the Office of Science at the Food and Drug Administration’s Center for Tobacco Products, was leaving to take up a position at Philip Morris International. The departure comes amid a crisis for the agency as it continues to delay determining the fate of hundreds of thousands of e-cigarette products.

In September 2020, e-cigarette manufacturers were required to submit pre-market tobacco product applications to continue offering their products for retail sale. The following September, the FDA issued denial orders for nearly a million flavored e-liquid e-cigarette products, prompting many small-business makers – all expected to be on the market since 2016 – to switch from nicotine. derived from synthetic nicotine tobacco.

Of course, lawmakers – who only seem to move quickly on vaping-related issues and nothing else – introduced and passed legislation allowing the FDA to regulate synthetic nicotine as a tobacco product. Thus, manufacturers of e-liquids and other vaping products had to submit a new application by May 14 to market their now newly reputed tobacco products.

Throughout the process, the FDA has been bombarded by members of Congress, so-called public health groups and anti-vaping campaigns to wield its executive authority and enact a myriad of standards, including a ban on flavors and arbitrary levels of nicotine.

One thing is certain in this whole application process: the agency has neglected the science. Now, apparently, science has had enough and is stepping back in favor of a tobacco company that is more committed than the FDA to reducing the number of adults who smoke.

Electronic cigarettes and vaping devices are not the only tobacco harm reduction products available to adult consumers. Tobacco harm reduction – the idea that consumers experience the benefits of nicotine without the harms associated with burning tobacco – is found in smokeless tobacco, snus and heated tobacco products.

Although the agency has been slow to clear pending applications, the FDA recognizes that tobacco products exist on a continuum of harm, with combustible cigarettes being the most harmful and nicotine replacement therapies being the least harmful. .

After receiving marketing authorization through an application (or other regulatory route), manufacturers can then request an order of modified risk tobacco products. To date, the FDA has only authorized 14 such orders.

Philip Morris’ heated tobacco product – Iqos – received a marketing order through the application pathway and a modified risk order. Unfortunately, due to a patent dispute, US adult tobacco users cannot purchase FDA-cleared Iqos. But Philip Morris’ new tobacco harm reduction product is leading to a sharp drop in smoking rates in other parts of the world.

In Japan, heated tobacco products, including Iqos, have helped reduce the volume of cigarettes sold by 42% since 2016. Additionally, researchers from the American Cancer Society reported that “the introduction of Iqos probably reduced cigarette sales in Japan.”

While the FDA may recognize the tobacco harm reduction potential in products like Iqos, the agency still refuses to understand the data that indicates adults are using — and enjoying — flavors in e-cigarette products. The role of flavors helps adults quit smoking and stay smoke-free.

As there were nearly one million flavored e-cigarette products for which the FDA issued denial orders, the flavors are popular among adult e-cigarette users. This is also highlighted in several surveys and studies.

For example, a 2018 survey of nearly 70,000 U.S. adult vapers “found that flavors play a vital role in the use of e-cigarettes and vaping devices,” with 83.2% and 72.3 % of survey respondents who say they vape fruit flavors and dessert flavors respectively. Additionally, a 2020 study found an association between flavors and smoking cessation. In a cohort study of more than 17,900 participants, the authors found that “adults who started vaping e-cigarettes without tobacco flavors were more likely to quit smoking than those who vaped tobacco flavors.

Unfortunately, these studies don’t seem to sway the FDA, which seems to be pandering to the blind wishes of lawmakers, rather than reviewing the data, science, and sheer number of products to determine adults’ access to less harmful alternatives.

Holman’s departure from an agency that claims to want to reduce smoking to a tobacco company is more indicative of an underlying theme: tobacco and vaping companies are more committed to helping adults quit smoking than the FDA.

Lindsey Stroud is director of the Consumer Center of The Taxpayers Protection Alliance. She wrote this for Inside


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