FDA Lands on Wrong Side of Tobacco Harm Reduction

Less than one month ago, Dr. Scott Gottlieb, commissioner of the Food and Drug Administration (FDA), announced “new steps” the FDA would be taking to address the “epidemic of youth e-cigarette” use. Gottlieb issued  warnings to the manufacturers of popular e-cigarette devices, informing them they must show how they are working to keep their devices out of the hands of minors. The agency also put 1,300 retailers on notice about sales to underage customers. The FDA further threatened to ban flavored e-cigarettes and will also consider banning all online sales. Coincidentally, big tobacco stands to benefit from an FDA crackdown on e-cigs, analyst says.

But the FDA wants the public to believe the agency is still continuing its age old mission of getting people to quit using harmful, combustible tobacco cigarettes. Gottlieb prefaced the details of his e-cig crack down with some lip service acknowledging the dangers of tobacco use: “Smoking remains the number one preventable cause of death in America, killing nearly half a million people a year.”  He admits “what primarily causes death and disease from tobacco use isn’t the nicotine in these products. It’s the act of lighting tobacco on fire to free that drug for inhalation. While it’s the addiction to nicotine that keeps people smoking, it’s primarily the combustion, which releases thousands of harmful constituents into the body at dangerous levels, that kills people.”

On the one hand the FDA admits the serious health risks of tobacco use and on the other, the agency is gearing up to cripple the industry that has created the most promising tobacco cessation tool ever to hit the market. It's a tension the agency is not unaware of: "Inevitably what we are going to have to contemplate are actions that may narrow the off-ramp for adults who see e-cigarettes as a viable alternative to combustible tobacco in order to close the on-ramp for kids," he told reporters. "It's an unfortunate tradeoff."

It's also an immoral trade off. There has never been any equivalence between addiction to nicotine and addiction to smoking. Nicotine products have been sold in drugstores to help smokers quit without a prescriptions for years. Big pharma's Nicoderm (patch) and Nicorette (gum) are widely available (you can buy them online!) and are the preferred method of weaning smokers off of cigarettes even if they haven't been especially successful. (Is nicotine even bad?) To make a calculation that more smoking-related addiction and deaths are the price we must pay to keep teenagers off of nicotine is just macabre.

In fact, we don't have any evidence teenagers who use e-cigs will move on to tobacco.  Teen smoking is actually at an all time low. And of course the fact is that it is already illegal to sell both e-cigarettes and cigarettes to minors. If the FDA succeeds in damaging the e-cig industry, who knows how many teens will take up smoking rather than vaping. Is the FDA so naive they think teens will stay away from tobacco cigarettes once they can't get their hands on an e-cig?

If you think the government is not serious about going after the manufacturers, last week the FDA hit the very popular e-cig manufacturer Juul with a surprise inspection. "The FDA conducted an unannounced inspection of Juul Labs' San Francisco headquarters, in which it sought more information about the e-cig maker's sales and marketing practices, the agency said. It collected 'over a thousand pages of documents.'"

Juul has been cooperating with the FDA, so I'm not sure why the "surprise" visit was necessary.

"Across this category, we are committed to taking all necessary actions, such as inspections and advancing new policies, to prevent a new generation of kids from becoming addicted to tobacco products," the FDA said in a statement. [I note that e-cigs are not tobacco products.]

Juul has released more than 50,000 pages of documents to the FDA since April to support its public statements about preventing underage use, Juul Labs CEO Kevin Burns said in a statement.

"We want to engage with FDA, lawmakers, public health advocates and others to keep Juul out of the hands of young people," Burns said. "The meetings last week with FDA gave us the opportunity to provide information about our business from our marketing practices to our industry-leading online age-verification protocols to our youth prevention efforts. It was a constructive and transparent dialogue."

In another show of good faith, Juul has introduced a lower level nicotine product to help those who want to transition off of nicotine.

One has to wonder why the FDA isn't more focused on the retailers instead of the manufacturers since they are the ones breaking the law and selling to minors. It's as if the FDA wants to out-source the power of enforcing its regulation to the manufacturers, when the manufactures don't have the arsenal (no pun intended) that government has to conduct enforcement. If the FDA would enforce its regulations with retailers they wouldn't have to come up with silly measures to make e-cigs unappealing to minors. Getting rid of flavored products, which have helped so many people quit tobacco and transforming e-cigs into a product that is no longer useful for those who want to kick the habit makes no sense, unless your issue really isn't helping people quit combustible tobacco.

The British are way ahead of the U.S. on this issue. They recognize that e-cigs are 95% less dangerous than combustible tobacco and their government encourages smokers to quit with e-cigarettes. Let's hope the FDA gets its act together and starts helping smokers quit rather than putting obstacles in their way.