FDA did the right thing when it withdrew its 2022 Juul marketing denial order; it should finish the job quickly by prohibiting Juul on solid grounds

On June 6, 2024, two years after the FDA issued, then suspended its Marketing Denial Order for Juul e-cigarettes based on narrow toxicology issues, FDA formally withdrew the MDO. This does not mean that the FDA has authorized Juul for sale in the US, it just lets FDA start over in its assessment of whether allowing marketing of Juul is “appropriate for the protection of public health.”

FDA made the right decision. As I noted back in 2022 when FDA issued the MDO, “Basing its decision on a narrow (but undisclosed to the public) toxicological basis raises the question whether FDA is just delaying addressing the hard realities of e-cigarette use and leaves open the possibility that even if FDA prevails in court, Juul may be able to amend its application to remedy the (unknown to the public) issue FDA identified (a point Juul made publicly).”

After years of consideration, the FDA now has a clean slate on Juul, so it can quickly address the core realities that it ignored in the 2022 MDO:

1.  e-cigarettes as consumer products do not help smokers quit (or, “switch completely” in the tobacco industry and FDA’s lexicon)
2. e-cigarettes, including menthol flavored e-cigarettes, led by Juul, have recruited millions of kids to nicotine addiction
3. e-cigarettes impose similar risks as cigarettes for some diseases, and nearly as high a risk for others, so even for adults who switch, there is not much harm reduction
4. Many adults who use e-cigarettes continue to smoke (i.e., are dual users), which is riskier than just smoking.

Recent research has suggested that, thanks to its nicotine salt technology, Juul is more harmful to hearts and lungs than earlier generation e-cigarettes and is as damaging to blood vessels as cigarettes.

FDA has been considering Juul for years. It’s time for them to make a final defensible decision soon. For the reasons outlined above, they should conclude that allowing the sale of Juul is not “appropriate for the protection of public health” and issue a marketing denial order for Juul.

My guess, based on their actions to date, which are based on unfounded assumptions that e-cigarettes help smokers quit and are substantially less dangerous than cigarettes, is that they will allow tobacco Juul, but prohibit the flavored versions.

In any event, FDA must prohibit Juul 2 and other bluetooth enabled tobacco products. Bluetooth capability, which Juul and Altria are promoting as a way to restrict youth use, opens the door to active control of nicotine delivery by the e-cigarette by the company, which could greatly increase addiction (and profits).