Just before Thanksgiving, Rep. John Boehner (House Speaker), Rep. Kevin McCarthy (House Majority Leader), and Rep. Fred Upton (Chairman of the House Energy & Commerce Committee) cosigned a letter to the Secretary of the Department of Health and Human Services, Sylvia Burwell. The full text of this appears below. In this letter they asked the FDA to consider changing the February 15, 2007 grandfather date for newly deemed tobacco products. They go on to suggest that the grandfather date be moved, perhaps to April 25, 2014, the day that FDA’s proposed regulations were submitted, or to a future date when the regulations are finalized.
As CASAA members know, the February 15, 2007 grandfather date, if implemented in the final deeming regulation that includes e-cigarettes, would have the practical effect of removing 99.99% of the e-cigarette products currently on the market. All deemed products not on the market as of that date would be forced to file Premarket Tobacco Applications (PMTA), a process so convoluted, time-consuming, and expensive that the FDA itself estimates that only 25 PMTAs will be filed. (See this post for a summary of CASAA’s comments to the FDA regarding the deeming regulations in general and this post for CASAA’s comments to OMB/OIRA regarding how the deeming regulations violate the terms of the Paperwork Reduction Act.)
While changing the grandfather date is a helpful short-term solution, it is by no means a good long-term solution. To put it bluntly, the purpose of the Smoking Prevention and Tobacco Control Act (TCA) is not to provide legitimate regulation but to inch toward prohibition. The rules are designed to make all products less appealing to consumers in an effort to reduce use. Whether or not one thinks this is appropriate for traditional cigarettes, it is clearly not the right basis for regulating e-cigarettes. Not only is there no reason to discourage e-cigarette use by adult consumers, there is every reason to encourage its use among the smoking population.
FDA has signaled that its plans for regulating e-cigarettes will also include lowering their quality to make them less appealing to consumers, such as by limiting flavors. Given that the TCA makes clear in its very title that prevention and control -- not beneficial regulation -- are the goals, and given the FDA's demonstrated willingness to happily spread disinformation about e-cigarettes, consumers should have little confidence that FDA will regulate e-cigarettes appropriately. Flavors, diversity, advertising, online sales, and acceptable nicotine concentrations are all potentially on the chopping block if FDA gains regulatory control over e-cigarettes under the TCA.
In the next several days, CASAA will issue a Call to Action asking consumers to write to their U.S. senators and representatives urging Congress to change the grandfather date as a short-term solution, but to consider also the long-term problems associated with including e-cigarettes in a regulatory scheme so poorly designed for these potentially life-saving products.