July 16, 2019
A friend outside the US sent me this flyer, which PMI is using to promote IQOS (high quality JPEG image):
July 16, 2019
On the CNBC special on vaping that ran on July 15, 2019, Juul CEO Kevin Burns said “I’m sorry” for all the kids who are using his product and repeated the Juul line that it was all an accident that all those kids are buying their products.
Apparently, he forgot all that social media marketing and parties they bought and all the parties theu threw for young adults.
If he was really sorry, Juul would not be spending $1.5 million (and likely more in the future) trying to trick voters into overturning San Francisco’s flavor ban, making it impossible to enforce existing laws like Tobacco 21, and preempting any regulation of e-cigs by the Board of Supervisors. Juul would also not be spending money to overturn Livermore’s similar legislation.
It is important to emphasize is that all the SF (and Livermore) laws say is that Juul needs to submit an application to the FDA that convinces them that allowing the sale of Juul would be good for public health.
July 16, 2019
The health groups had a big win a few days ago when a federal court ordered the FDA to require e-cig companies (and other newly deemed products) to get their applications into FDA by May 12, 2020, 10 months from now. The court also said the FDA had to act within a year or the products would have to come off the market. This is a big improvement over the August 2022 deadline FDA wanted with no limit on how long it had to review the products.
The FDA told the court they could accomplish the review with a 10 month start date, so hopefully the FDA will not appeal the ruling.
Maybe Juul will then stop spending millions of dollars fighting San Francisco and other ordinances prohibiting the sale of e-cigs until the FDA reviews applications for sale and cerifies that they are "appropriate for public health." Former FDA Commissioner Scott Gottlieb doubted that Juul could pass that bar given its stunning success at recruiting kids. Maybe that is why Juul didn't apply apply back in 2016.
Here is the health groups' press release on the case:
In Public Health Win, Federal Court Sets 10-Month Deadline for E-Cigarette Makers to Apply to FDA to Keep Products on the Market
July 16, 2019
Candice Bowling and our colleagues at UCSF submitted this public comment to FDA's request for information on what the agency should do about cannabis. The Regulations.gov tracking number is 1k3-9b1v-110j. A PDF of the comment is available here.
Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments
Docket No. FDA-2019-N-1482
Candice Bowling JD, MPA, Amy Y. Hafez, PhD, Lauren K. Lempert, JD, MPH, Matthew L. Springer, PhD, Neal L. Benowitz, M.D., Stanton A. Glantz, PhD
University of California San Francisco
June 20, 2019
I am proud that the San Francisco Board of Supervisors voted unanimously to end the sale of e-cigarettes in San Francisco until such time as e-cigarette companies get premarket authorization to sell their products.
The only reason the City had to do this is because the FDA is not doing its job by requiring e-cig companies to obey the law.
Even given FDA's cavalier attitude toward the law (which has been rebuked by a federal court in Maryland), there is nothing that prevented Juul and the other e-cig companies from submitting premarket authorization applications to the FDA three years ago. To date, not a single company has submitted such an application.
Having said that, FDA's recent authorization to sell IQOS in the USA makes me worry about what FDA will do about e-cigs once they do start getting applications. As detailed in an earlier blog post, FDA's standard for allowing new tobacco products to be sold is effectively that they are "not as bad as a cigarette." Just about anything meets that standard.