How FDA made a “gigantic, chaotic” mess of the vaping market

Yikes! This is my first blog post in more than six months. I’m writing less than ever (obviously) as I gradually ease into what a friend calls “rewirement.” But I can’t let go of the story of vaping and smoking, largely because the US government gets it so wrong, as does much of the coverage in the mainstream press. Meantime, the so-called public interest groups that continue to oppose safer nicotine products and demonize the tobacco industry continue to do more harm than good.

As a new administration takes over in Washington, the issue is more timely than ever. Trump & Co. have an opportunity to, quite literally, save millions of lives by fixing the FDA’s approach to e-cigarettes and other reduced-risk nicotine products. Interestingly, just before the transition in DC, FDA regulators authorized the marketing of 20 Zyn nicotine pouch products including those in flavors citrus, cinnamon, chill and cool mint. This was a welcome sign that the FDA’s Center for Tobacco Products will support the idea of tobacco harm reduction—that is, the idea that people who can’t or won’t quit smoking traditional cigarettes should be encouraged to switch to safer nicotine products, like Zyn.

If you haven’t been paying attention — or if you’ve read the often wrong-headed coverage of e-cigarettes — you may be surprised to learn that vapes and other means of delivering nicotine without burning tobacco are, first, much safer than traditional cigarettes and, second, one of the most effective, if not the most effective, way to help people who smoke give up their deadly habit.

Cigarettes kill about half of long-time smokers; e-cigarettes have yet to kill anyone, as best as we can tell. Well-regulated safer nicotine products have helped to drive down smoking rates in Japan, Norway, Sweden and the UK, among other places.

But not here — thanks in large part to the FDA. Last week, the nonprofit drug-policy website Filter published my story about the agency’s regulation of vaping under the headline “How the FDA made a “gigantic, chaotic mess of the US vapes market.” Here’s how the story begins:

Twenty-one years ago, a Chinese pharmacist named Hon Lik patented the first electronic cigarette. Lik smoked heavily, and hoped to help people quit smoking by giving them the nicotine they crave in a safer way.

His invention succeeded wildly. It spawned a $28-billion industry that is disrupting the global tobacco business. Leading tobacco control experts say that vapes have begun to reduce the disease and deaths caused by smoking, which kills about 480,000 people a year in the United States. Vaping is much less harmful than smoking, and more effective for smoking cessation than nicotine patches or gum.

Yet US regulators have made a dismal mess of the vapes market.

Instead of promoting safe and effective vaping, the federal government, led by the Center for Tobacco Products, a unit of the Food and Drug Administration, has gone to great lengths to keep vapes and other reduced-risk nicotine products out of the hands of consumers who want them.

The FDA’s unwillingness to authorize the sale of flavored vapes has created a vast, unregulated black and gray market of e-cigarettes, many imported from China. This was entirely predictable. Banning a product that people want almost never works — a lesson that regulators should have learned from Prohibition but did not.

Unfortunately, FDA was heavily influenced by congressional Democrats and anti-tobacco groups like the Campaign for Tobacco-Free Kids which, true to its name, focuses narrowly on protecting kids from tobacco while ignoring the needs of about 28 million American adults who smoke, Teen smoking and teen vaping are both way down, as it happens, and the Tobacco 21 law passed during the first Trump administration is expressly designed to keep tobacco products out of the hands of people under 21. But the adult smokers are being denied access to innovative nicotine products, like e-cigs, that could save their lives.

There’s much in my story for Filter. You can read it here.