It is a dark day for science-based regulation and anyone who wants to see fewer Americans die from tobacco-related diseases. In the early hours of Monday morning, Congress finally compromised on a budget deal, averting a government shutdown through September. Democrats today are celebrating the $1 trillion deal—not because they succeeded in working with their colleagues across the aisle but because they managed to excise numerous Republican-led amendments from the final draft. One of these amendments was a bipartisan measure to preserve the market for electronic cigarettes—lower-risk tobacco alternatives that research has shown to be an effective means of smoking cessation. It may be a political win for Dems, but for those of us who care about improving public health and preventing the nearly half-million tobacco-related deaths in the U.S., it is a tremendous loss.
“The Omnibus does not include a House provision allowing thousands of unregulated tobacco products to escape full FDA review,” crowed a press release issued by Democrats on the House Committee on Appropriations. The provision referenced is H.R. 1136 (a.k.a. the “Cole-Bishop amendment”), an amendment to the agricultural appropriations bill introduced by Reps. Tom Cole (R-OK) and Sanford Bishop (D-GA). The bill would have amended the Tobacco Control Act (TCA) enacted by Congress in 2007, which gave the Food and Drug Administration (FDA) authority to regulate tobacco products. It would not allow e-cigs to “escape” the agency’s regulatory arm but merely afford e-cigarettes the same leniency offered to traditional cigarettes.
As we noted in our coalition letter last week:
The Cole-Bishop Amendment and House Resolution 1136 would not weaken the TCA or the ability of the FDA to impose additional product standards or regulations on new products in the future. That is precisely why the efforts are bipartisan, because there is recognition that while regulations that protect consumers are important, the Rule imposed burdens that neither protect consumers, nor acknowledge that the consequence will be the new industry’s demise.
When Congress enacted the TCA, it “grandfathered” in existing tobacco products so that, while they would still be subject to FDA regulation and oversight, they would not need to submit a pre-market tobacco application (PMTA) before being allowed to continue offering their products to consumers. However, when the FDA decided in May 2016—without input from Congress—that e-cigarettes would be defined as tobacco products (despite containing no tobacco) it did not afford e-cigs the same courtesy. Instead, because no electronic cigarettes existed on the market prior to 2007, every single vaporizer and flavor would have to file a PMTA, which might cost as much as $400,000 per application, with no guarantee that FDA will approve any of these applications. FDA itself noted that it expects the process to eliminate 99% of the existing e-cigarette market.
The FDA insisted that it does not have the authority to change the grandfather date since it is written into the legislative language for the TCA. That is all that H.R. 1136 sought to do: modify the grandfather date so that the vapor products currently available to consumers would not need to exit the market while waiting for FDA approval. Vapes would still be banned for minors, FDA would still have the authority to require manufacturers submit detailed product formulas, to review modifications to products, issue product standards and employ enforcement tools to monitor post-market issues like misbranding and adulteration.
According to estimates, around half of all tobacco smokers will die as a result of their habit—about half a million Americans each year. On the other hand, research indicates that vaping is around 95 percent less harmful than traditional smoking. By 2014, around 9 million Americans used e-cigarettes with almost a fourth of those surveyed classifying themselves as “recent former cigarette smokers.” Only 4 percent of those surveyed who had ever tried an e-cigarette were “never smokers.” Thus, unless Congress takes action, these millions of Americans who use e-cigarettes as a safer alternative to cigarettes may be forced to return to cigarettes.
Perhaps the most galling aspect of the Democrats victory lap is that they are painting it as a triumph over “big tobacco.” Of the more than 8,500 vape shops around the nation, most are not owned by “big tobacco” but are small businesses that created even more jobs—many of which are already going out of business thanks to the FDA’s new rules. In reality, it is likely that only the largest tobacco companies will be able to afford the approval process. The products that make it through the FDA process, if any do, will be more expensive (thanks to the regulatory cost and lack of competition), less customizable, and therefore less attractive to a greater number of current smokers. The variety of flavors, which has been shown in early research to be key in keeping vapers from returning to cigarettes, will also be diminished. It is possible the FDA won’t approve any flavors beyond “tobacco” and “menthol” as it does for cigarettes; something so-called public health advocates are already urging FDA to do.
Democrats could have worked with their colleagues to update FDA rules in a way that recognizes the spectrum of risk associated with various nicotine-containing products and encourages the creation of safer tobacco alternatives. Instead, they chose to play party politics and let the FDA lump demonstrably safer products together with deadly cigarettes under the same rules designed to discourage use.
So, congratulations House Dems; enjoy your win. Don’t let lives lost get in the way of politics.