FDA Commissioner Marty Makary said he resigned in protest against the Trump administration's push to allow tobacco companies to begin selling fruit-flavored vapes.

getty

Health and Human Services Secretary Robert F. Kennedy Jr.’s chief spokesperson Rich Danker resigned this week, citing “irreconcilable differences” over an effort to promote fruit-flavored e-cigarettes. This followed Food and Drug Administration Commissioner Marty Makary’s resignation, a purported reason for which involved a disagreement regarding the second Trump administration’s push to permit tobacco companies to begin selling flavored vapes. Both Makary and Danker expressed worry about possibly fueling addiction, specifically among the youth, which aligns with the first Trump administration’s view on this matter.

The first and second Trump administrations are strikingly different, starting with many of the unconventional cabinet picks, one of whom is Robert F. Kennedy Jr., Secretary of the Department of Health and Human Services. But despite Kennedy’s atypical leadership, several top officials at HHS have commanded respect from a broad swath of the establishment, including FDA Commissioner Makary. However, Makary’s departure along with Kennedy’s spokesperson signal not only a change in personnel, but also a pivot in policy between the first and second Trump administration on vaping, e-cigarettes and nicotine-containing products more generally.

Makary’s opposition to fruit-flavored vapes clashed with President Trump whose stated goal is to “save vaping.” This constitutes a rather dramatic shift in tone and policy compared to 2019, when, following a rise in teen vaping, Trump and his health officials announced they would ban most flavored e-cigarettes, stating the country needed “strong rules and regulations.” The move to outlaw flavored vapes was over concerns that their rising popularity threatened the health of a generation of adolescents. At the time, the Centers for Disease Control and Prevention recommended that people “persons consider refraining from using e-cigarette, or vaping, products that contain nicotine.”

Now, however, while the FDA continues to prioritize banning illicit vapes, it recently authorized the first fruit-flavored e-cigarettes approved for sale to adults 21 and over. These are intended to offer an appealing alternative smoking cessation product for adults who wish to quit. Other long-term options include bupropion and nicotine replacement therapy.

With the exception of traditional, combustible cigarettes, the Trump administration’s policies on nicotine-containing products have taken a noticeable turn away from regulation. From e-cigarettes to nicotine pouches, the administration has pursued an easing of the path for market availability despite potential public health concerns.

E-cigarettes are devices designed to deliver nicotine or other substances. Vaping refers to the practice of inhaling vapor through e-cigarettes or vape pens. Nicotine pouches are small sachets of nicotine and additives that are placed between the gum and lip. The stimulant is then absorbed into the bloodstream. By providing nicotine to users without the harms from cigarette smoking, the pouches are now formally considered by the FDA to be a harm reduction aid for smokers who wish to quit and reduce exposure to toxic substances. But similar to e-cigarettes and vaping, many who consume nicotine pouches are not smokers and a growing number are not adults. The nicotine content has potential risks related to both cardiovascular and oral health as well as possible addiction.

The new policy on vapes has specifically raised concerns from pediatrician groups and advocacy organizations about the potential impact on minors, should these products land in their hands. Critics argue that the flavors could appeal to youth and expose them to potential nicotine addiction, lung damage and other health risks. They cite the FDA’s longstanding position that flavors pose a substantial risk to young people.

Companies manufacturing the products say there are sufficient safeguards against youth consumption, and they will not target people under 21.

And public health experts consider e-cigarettes and nicotine pouches less harmful alternative to tobacco-burning cigarettes. To illustrate, a comprehensive review by Public Health England, the British counterpart to the Centers for Disease Control and Prevention concluded that vaping is 95% less dangerous than smoking. In fact, in the United Kingdom the Royal College of Physicians explicitly tells doctors to promote e-cigarettes “as widely as possible” to people trying to kick the smoking habit.

Nevertheless, there can be dangers associated with vaping. Some people have died or come down with vaping-related pulmonary illnesses. But in most instances, apparently added substances were to blame. For example, in a study published on vaping-related illness, 87% of patients said they had vaped tetrahydrocannabinol, or THC, the main psychoactive ingredient in marijuana, from prefilled cartridges purchased from “informal sources.” Another publication appears to confirm the hypothesis that the majority of vaping-related harms likely stemmed “from one or more inhaled toxic substances.”

High level resignations in protest against the Trump administration’s push to allow tobacco companies to begin selling fruit-flavored vapes suggest a break ...

Whether this also applies to other contentious areas, such as the abortion pill mifepristone, where there may have been differences of opinion between Makary and administration officials, remains to be seen.