We Can Further Reduce Smoking

For what are often very different reasons, Republicans and Democrats are prone to anger when government doesn’t work. Conservatives are, by nature, skeptical of regulation. Progressives, by contrast, are frustrated when bureaucratic bungling gives the government a bad name. So it’s no surprise that there is growing bipartisan outrage over the Food and Drug Administration’s (FDA) failure to efficiently review novel reduced-risk products and allow them to enter the marketplace. Expediting consumer access to these products is both an obvious and commonsense approach to reducing the harm of smoking. The bottom line is clear: With the invention of new, safer nicotine delivery products, we have at our disposal a technology that is poised to dramatically reduce the nearly 500,000 smoking-related deaths that occur each year in America. But despite these innovations, the FDA is dragging its feet in making these devices available. At a moment when faith in public institutions is, in fact, flailing, the current predicament is utterly outrageous. 

If we had the power to end the scourge of unhealthy choices in America, it would surely be for the greater good. But until someone invents that magic wand, smart public health policy demands that we steer people away from the most dangerous behaviors. As many know, among the most harmful ways to consume tobacco is through smoking it. Cigarette smoke fills the lungs, and that smoke and tar put smokers at great risk of a whole range of illnesses and conditions, with cancer and emphysema among them. That’s where smokeless tobacco and nicotine products come in. These new products are an incredibly effective strategy for reducing harm. Why, then, are federal regulators preventing so many of them from hitting the market?

This isn’t just an academic question. Millions of Americans are already aware of the health benefits of reduced-risk tobacco and nicotine products. Many people understand, through using vapes as a tool, that they can help them to avoid the risks borne of smoking. And in the absence of the FDA making safe, regulated, domestically-produced nicotine delivery devices available to domestic consumers, the market is increasingly flooded instead with unsafe, unregulated, Chinese alternatives. And that’s what’s so mind-boggling about the current state of affairs. It would be one thing if the FDA had decided that they simply were not going to allow Americans to access this new off-ramp from smoking. Right now, they aren’t even doing that. Given current  lax enforcement standards, they’re implicitly pointing those desperate to quit smoking toward the purchase of rogue, imported alternatives.

Earlier this month, the head of the FDA’s Center for Tobacco Products (CTP) was called, once again, in front of Congress to explain the ongoing morass. And frustrated members of Congress from both parties asked some very pointed questions that all centered on the same head-scratching failures. Why haven’t regulators made this promising new technology available to the people who need help quitting smoking? Why aren’t they doing a better job keeping unregulated vapes out of the hands of unwitting consumers? Why isn’t the FDA being transparent about where they are in the approval process, or what more needs to be proven before these vapes can be made more widely accessible? What, in the end, is the problem? And yet, like in previous hearings, the FDA provided very few satisfactory answers.

The frustration displayed on Capitol Hill reflects wider public opinion. A recent poll conducted by Peak Insights found that a majority of respondents (68%) are dubious of whether raising taxes and imposing restrictions on tobacco products will reduce smoking rates. A clear majority (54%) believe the problems associated with smoking could be better resolved by adopting policies that encourage smokers to switch to FDA-regulated alternatives. And yet, while millions of applications have been submitted for review, only a handful have been approved. The majority have either been refused or rejected while many others simply sit in regulatory limbo for multiple years. 

The salve here is clear. To meet market demand, stem the flood of unregulated vapes from China, and pick up this new cudgel against the scourge of smoking, the FDA needs to streamline its review process, allocate sufficient resources to handle the deluge of applications, and beef up its enforcement capabilities. Combined with stricter penalties, more frequent inspections would go a long way toward protecting public health. Here, we have a situation where a new technology holds the potential to have outsized impacts on a carcinogenic scourge generations in the making. As demonstrated by the frustration pouring from members on both sides of the aisle, the FDA has to date been more a hindrance than a help in serving the common good. That needs to change—and fast.