In what should be taken as a note of common sense amid the highly contentious debate surrounding the Food and Drug Administration’s oversight of tobacco products, reports have surfaced that the White House intervened to delete sections of draft FDA regulations promulgated early last month that would have required flavored e-cigarette liquids be removed from the market almost immediately.
This is good news. As I detailed in a recent policy study for the R Street Institute, vapers use flavors to help sustain the level of nicotine they derive from e-cigarettes. Many vapers rotate flavors through the day to allow them to continue vaping. And most importantly, these vapers report that without flavors, they are likely to return to smoking.
This is crucial, because evidence demonstrates that e-cigarettes pose less than 5 percent of the risk of potentially fatal illness presented by combustible tobacco cigarettes. Encouraging smokers to switch to e-cigarettes offers the opportunity to improve public health outcomes tremendously.
Nonetheless, some in the U.S. public health community point to what they allege is selective marketing of e-cigarettes to young people, and focus in particular on the role of flavors they say are targeted at children. The proposed FDA rules wisely address this concern by requiring that e-cigarettes may not be sold to children in any state. But proposals to remove flavored e-liquids from the market are misguided.
For one thing, surveys of confectioners and candy makers reveal that there is no such thing as “children’s flavors,” per se. E-cigarette flavors identified by critics as attractive to children are by no means the most popular with that audience. And there is no evidence that curiosity about a specific flavor has compelled children to try e-cigarettes. Despite this lack of evidence, the FDA recommended a ban on flavoring in their original submission to the White House.
With the change in the rules, flavored e-liquids will join other vaping products in enjoying a two-year grace period, during which their manufacturers may submit marketing applications to continue to sell their products. Without the change made by the White House Office of Management and Budget as part of the interagency review process, flavored e-liquids would have had a grace period of only 90 days.
The news highlights radically divergent paths taken by health regulators on both sides of the Atlantic with regard to the role of e-cigarettes in smoking cessation and tobacco harm reduction. In the United Kingdom, e-cigarettes are dispensed by the National Health Service. Meanwhile in the United States, e-cigarette products introduced since February 2007 – representing almost 99 percent of the market – could effectively be banned within two years under the current FDA regulations.
The U.S. House currently is considering H.R. 2058, legislation that seeks to modify the “grandfather” date for products included in the current FDA regulations. One hopes that Congress would go one step further and amend the FDA tobacco law in a way that would mandate the FDA to consider the substantial public health benefits that e-cigarettes offer both to current smokers and to teens who otherwise would become lifelong smokers.
By deleting references to flavor in the otherwise exhaustive FDA regulations, the White House has shown a degree of insight into an important public health problem. Adult smokers could benefit from flavors in e-cigarettes.
Photo courtesy of Vaping360: http://vaping360.com/
Dr. Edward Anselm, M.D., is a senior fellow with the R Street Institute.