Trump: Look at the Slow-Moving FDA
The Food and Drug Administration’s approval of low-risk tobacco pouches is welcome, but why did it delay for more than four years?
SACRAMENTO, Calif. — The U.S. Food and Drug Administration’s recent approval of a product known as Zyn is a leap forward for the cause of tobacco harm reduction, which encourages smokers to switch from dangerous combustible cigarettes to less dangerous products. However, the agency’s inexplicable delay in doing so raises serious questions about the FDA’s bureaucratic and unaccountable approval process.
The delay of life-saving products has for decades been a theme at the FDA. The new administration has been busy with its shock-and-awe approach to immigration and other federal issues. Although it would be less attention-grabbing, a targeted effort to streamline approvals at this agency could really improve public health. The Zyn case provides a good excuse for the administration to put the FDA on its radar.
It’s beyond debate that smoking cigarettes is a terribly dangerous habit. Public health nannies, including those in California, have responded with a Prohibitionist approach that bans many vaping and alternative nicotine products. It’s perverse. Under state law, smokers can walk into a convenience stores and buy the most dangerous tobacco products available, but are forbidden from buying many of those (with flavors) that are 95 percent less harmful than cigarettes.
At the federal level, the FDA has put through the wringer companies that want to market these lower-risk nicotine products. Zyn — and similar products from various manufacturers — are small pouches that contain pharmaceutical-grade nicotine of the type found in nicotine gum. Users place them between their lip and gum and get the nicotine that they’re dependent upon — without inhaling the toxic chemicals found in combustible cigarettes.
Obviously, it’s best for people to abstain from any tobacco-related products (although nicotine is a somewhat different issue), but the government shouldn’t take on the role of nanny for private decisions and dependencies. But from a public health standpoint, it can at least assure that less dangerous products are available rather than trying to limit them on store shelves in an apparent effort to keep them out of the hands of teens, who aren’t legally allowed to buy them anyway.
The FDA’s approval of 20 types of Zyn pouches includes some encouraging findings. The FDA concluded that “due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products … the authorized products pose lower risk of cancer and other serious health conditions than such products.” The agency agreed with evidence that “a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products.”
So the FDA agreed with the core argument that harm-reduction advocates make: that these products are safer (not totally safe, of course) than the alternatives and many smokers who switch make a permanent switch away from the really bad stuff. And given that California lawmakers banned the flavored versions of these products as a means to combat underage use, the state’s lawmakers ought to pay attention to this part of the federal statement: “The FDA reviewed data regarding youth risk and found that youth use of nicotine pouches remains low.”
As my R Street colleague and harm-reduction expert Jeffrey Smith noted in his opposition to a proposed Denver ordinance: “In California, a state that has applied the most stringent flavor prohibitions, the impact on access to flavored products was hindered very little, and smoking rates actually increased. This phenomenon was validated by a recent study where investigators showed that following flavor bans, the number of cigarettes used increased by 12 for every flavored pod not sold.”
So good for the FDA for its decision and its clear-headed rationale. But the process that arrived here leaves observers scratching their heads. Under its premarket tobacco application (PMTA) process for determining whether a company is legally allowed to market a new tobacco product, the U.S. Food and Drug Administration has 180 days from the filing to make its determination. In this case, the agency took 1,750 days — nearly five years — to get there.
And it hasn’t explained why. At the R Street Institute, we do significant work on harm reduction, so we’re pleased that it did get there — and that Zyn products remained on the shelves through the duration. But the agency hasn’t explained its slow-walking. Had, say, a tobacco, pharmaceutical, or medical-device company missed its FDA-imposed deadlines by more than four years, I’d imagine the agency would not have looked kindly on that. Why does FDA get to violate its own deadlines?
Here’s a specific reform idea. The FDA streamlines the approval process for products that are substantially equivalent, but it generally doesn’t do so for similar products from other companies. That means other companies will have to go through the tortuous process to get federal approval, which only limits the public’s access to potentially life-saving products. Allow them to do so. Many new products are popping up, and these companies may not have gone through the process or even submitted an application yet.
Then let’s break the FDA logjam for other items and finally do something about its foot dragging.