Onerous new FDA rules will increase smoking
New rules from the Food and Drug Administration could wreck the consumer-driven market for a broad range of products that reduce or eliminate many of the harmful aspects of combustible cigarettes, and drive millions back to smoking.
Under the FDA’s current proposal, nicotine-delivery products created after Feb. 15, 2007 — including e-cigarettes and other vapor devices already being sold and used by consumers — would be taken off the market until they pass a tremendously onerous and expensive authorization process.
The FDA’s proposed rules won’t reduce smoking; they will increase it. We’ll also likely see a “vapor underground” for these products that will further deteriorate consumer safety.
Rather than setting performance and quality standards, the FDA’s approach would shut down the electronic alternatives to which millions of Americans have switched to reduce their exposure to the risks associated with cigarette smoke. With those alternatives gone, many — if not most — of those users likely will return to traditional cigarettes.
That’s no problem for big tobacco companies, which have the resources to endure having their newer e-cigarette products removed from store shelves, particularly when the rules will drive many back to smoking. On the other hand, the FDA’s plan easily could wipe out the lion’s share of smaller vapor and e-cigarette innovators.
In other words, the FDA’s plan essentially will hand the future of tobacco and nicotine alternatives to big tobacco companies themselves. That seems a bizarre outcome for technologies that many have used to end their cigarette-smoking behavior.
To be clear, vapor products and e-cigarettes should be regulated. At the same time, we should question seriously the FDA’s wisdom in subjecting new, technologically advanced options to a regulatory framework designed specifically for traditional cigarettes. Rather than hoops, hurdles and lengthy regulatory processes, the FDA should establish clear warnings, ingredient disclosures, product benchmarks, inspections and even marketing restrictions for e-cigarettes.
We don’t have enough data to make definitive claims about the long-term consequences of many of the new products, but that’s the case with any novel innovation. We do know that a number of harmful chemicals and compounds in cigarettes aren’t present in many of these new products. Consumers should have the ability to make informed choices about innovative alternatives to smoking, rather than see the market unilaterally crushed by the FDA’s heavy-handed approach.
We’re having similar conversations across the nation related to companies like Uber, Lyft and Airbnb. While they share some broad features with taxis and hotels respectively, they represent market innovations that respond to consumer demand and that deserve a thoughtful and flexible regulatory approach.
At a minimum, Congress should move the proposed rules’ “look-back” period to a significantly more recent date. Nearly all e-cigarette products have come to market since February 2007. The FDA has stated clearly that it doesn’t have the authority to change that date, which was set in statute by the Family Smoking Prevention and Tobacco Control Act of 2009.
To be clear, simply changing the date is not a long-term solution. Any cutoff date will favor existing products over future innovators. That’s exactly the outcome those of us who believe in reducing the harms of tobacco want to avoid. However, it would preserve the current market while giving the FDA more time to improve its regulatory scheme.
In short, we should regulate alternatives to traditional cigarettes, but there’s a better, more commonsense way to do it. We make progress in America when innovators give consumers better choices; not when government takes those options away.
