• by Thom Forbes  @tforbes, September 13, 2018

Taking a decidedly aggressive regulatory stance in an administration that vigorously pushes deregulation, Food and Drug Administration commissioner Scott Gottlieb yesterday said addiction to the nicotine in e-cigarettes had reached epidemic proportions among underage youth. He announced the “largest single enforcement action in agency history” to curtail the marketing and selling of electronic nicotine delivery system (ENDS) to teenagers, and floated several possible actions, including a possible ban of flavored e-cigs.

“Let me be clear: Everything is on the table. This includes the resources of our civil and criminal enforcement tools,” Gottlieb said in a sweeping indictment of both retailers and marketers that also admits the FDA failed to recognize the extent of the ENDS problem when it announced a plan to reduce the death and disease caused by smoking a year ago but delayed regulations that could have removed many ENDS products from the market.

“Gottlieb announced the agency sent 1,100 warning letters to stores for the illegal sale of e-cigarettes to minors under the age of 18, and issued 131 fines to stores that continued to violate the restrictions on sales to minors,” reports CNN’s Sandee LaMotte.

“The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products,” Gottlieb proclaimed. 

He also said it “would look closely at a practice called ‘straw purchases,’ in which adults visit web-based stores and buy in bulk to resell to minors,” CNN’s LaMotte adds.

“If young adults go online and buy 100 units of a product to sell to teens, that activity ought to be easy for a product manufacturer to identify,” Gottlieb said.

“Today, we sent letters to five e-cigarette manufacturers whose products were sold to kids during the enforcement blitz and that, collectively, represent more than 97% of the current market for e-cigs -- JUUL, Vuse, MarkTen, blu e-cigs, and Logic. … They’re now on notice by the FDA of how their products are being used by youth at disturbing rates,” Gottlieb stated. 

The FDA gave those manufacturers 60 days to present “robust plans” to curtail the use of their products by minors.

“This may require these brands to revise their sales and marketing practices, including online sales; to stop distributing their products to retailers who sell to kids; and to remove some or all of their flavored e-cig products from the market until they receive premarket authorization and otherwise meet applicable requirements,” Gottlieb said.

“Juul has said that it continues to seek aggressive growth, including plans to raise $1.2 billion in funding, because of the potential health benefit to adult smokers who switch to e-cigarettes. After Wednesday’s announcement, CEO Kevin Burns said Juul will work proactively with the FDA, but argued that flavored products are aimed at adult smokers,” reports Nitasha Tiku for Wired.

“Meanwhile, Greg Conley, president of the American Vaping Association, called the FDA’s announcement a gift to the tobacco industry,” Tiku adds.

“No one should be surprised that stocks for Philip Morris International, British American Tobacco, and Altria all shot up following the announcement. Wall Street analysts know that bans on flavors in innovative products like JUUL will only help boost the profits of cigarette companies,” Conley says in a statement.

“Dr. Gottlieb’s aggressive approach against private industry is unusual for an official in the business-friendly Trump administration. … But critics said that his decision last summer to extend a deadline for e-cigarette manufacturers to demonstrate that their products comply with public health concerns helped perpetuate the current problem,” observe Sheila Kaplan and Jan Hoffman for the New York Times.

“It’s nice they want to do something but realistically, what are they going to accomplish this way when they could be so much more effective by following the regulatory plan that had been ready to put into place and that the commissioner postponed?” Diana Zuckerman, president of the National Center for Health Research, tells them.

Others were more positive about yesterday’s announcement.

“This is a very forthright message about the delicate balance in trying to pursue a harm reduction strategy for vaping products,” University of Waterloo public health researcher David Hammond tellsVox’s Julia Belluz.  “Helping smokers quit while ensuring kids aren’t getting hooked on nicotine isn’t an easy balance to strike, he added,” she writes, noting that the U.S. market for e-cigs expanded by 40%, to $1.16 billion, last year. 

Tobacco use is the leading preventable cause of death in the United States, according to the Centers for Disease Control, but e-cigs carry their own dangers. 

“Smokeless tobacco is a known cause of cancer. In addition, the nicotine in smokeless tobacco may increase the risk for sudden death from a condition where the heart does not beat properly (ventricular arrhythmias),” the CDC states.