On Wednesday, House appropriators will face a decision with major ramifications for efforts to combat smoking and protect public health. The Food and Drug Administration is poised to adopt rules that could cripple the e-cigarette industry, obstructing the availability of a safer alternative to cigarettes. The appropriators may be the last line of defense against wrong-headed action by the FDA.
E-cigarettes, and vaping products more generally, don’t burn tobacco, allowing them to deliver the nicotine that smokers crave without the cancer-causing tar that kills them. The nicotine solution contains flavoring and propylene glycol which, based on current evidence, is safe when inhaled over the short term – long term follow-up is needed to observe if any harmful effects show up later on. Smokers with asthma who have switched completely or partly to vaping products enjoy improved lung function and blood pressure.
Here’s the back story. In 2009, Congress gave the FDA power to regulate cigarettes and a few other tobacco products. Congress didn’t put e-cigarettes under FDA’s regulation, but it gave the FDA the option to extend its powers to cover e-cigarettes. In April 2014, FDA issued a proposal to do just that. FDA appears to be poised to finalize that proposal, putting e-cigarettes under the same rules as cigarettes.
Some of the FDA rules that apply to cigarettes should apply to e-cigarettes, like those that restrict access by minors. But, one part of the regulatory regime – the rules governing the introduction of new tobacco products – won’t work for e-cigarettes.
If a tobacco product wasn’t on the market on February 15, 2007, then the rules allow only two ways to introduce it. The manufacturer can show that the new product is substantially equivalent to something on the market on February 15, 2007. Or, the manufacturer can go through the costly and arduous process of filing a pre-market review application, which requires a large amount of scientific data.
Applying these rules to e-cigarettes would devastate the smaller vaping companies that account for much of the innovation in the industry. The problem is that there were almost no e-cigarettes on the market on February 15, 2007. So, almost no products would be grandfathered in and almost none of them could find a February 2007 product to which they’re substantially equivalent. In most cases, the only way to keep an e-cigarette product on the market would be to file a pre-market review application.
One part of the pre-market review process – the requirement that manufacturers demonstrate the safety of the devices and e-liquid – is welcome. But, two elements of the process are most worrisome. First, applicants must present research findings on the impact of the product on the population as a whole, including an examination of the likelihood of former smokers re-initiating tobacco use with the new product and the likelihood of smokers switching to the product instead of quitting completely or trying to quit with an FDA-approved medication. Second, applicants are required to demonstrate that the new product is beneficial to the public’s health by showing that it has a negligible (however that may be defined) impact on nonsmokers – especially youth – who might use the new product.
Performing the necessary investigations is extremely burdensome. The FDA estimates that it costs about $300,000 to prepare and file an application – some outside observers think the actual cost may top $2 million. In fact, the process is so arduous that cigarette companies have filed only a handful of pre-market review applications for new cigarette products since 2009. Now, multiply these demands by a factor of 10s to 100s, to account for an entirely new assessment for each device or e-liquid that a company makes.