WASHINGTON -- A rider that would have helped electronic-cigarette manufacturers better survive the upcoming U.S. Food and Drug Administration (FDA) deeming regulations was not included in the final $1.1-billion spending bill legislators approved earlier this month. Approved by the House Appropriations Committee’s Agriculture, Rural Development, Food & Drug Administration & Related Agencies Subcommittee in June, the rider would have exempted products already on the market from the FDA’s cost-prohibitive Pre-Market Tobacco Application (PMTA) requirement, allowing companies to instead submit a less costly substantial equivalence (SE) application.
Organizations like the American Lunch Association and the Campaign for Tobacco-Free Kids fought hard against the measure and praised the rider’s exclusion.
“The budget agreement reached by congressional negotiators delivers critical victories for America’s kids and health over the tobacco industry by rejecting proposals to greatly weaken FDA oversight of electronic cigarettes and cigars,” the Campaign for Tobacco-Free Kids said in a press release. “The budget agreement does not include a provision to limit FDA oversight of e-cigarettes and cigars already on the market. The agreement preserves the FDA’s ability to review these products and take action to protect our kids.”
Vaping advocates, however, stringently disagreed with such sentiments.
“The Campaign is wrong in stating that the appropriations rider would have removed the FDA's ability to review e-cigarette products,” Dr. Michael Siegel, a professor of Community Health Sciences at the Boston University School of Public Health, wrote on his Tobacco Analysis blog. “The rider would have actually strengthened the FDA's ability to review and oversee these products by forcing the agency to actually set safety standards, put an end to exploding batteries and ensure quality control. The rider would not have prevented the FDA from regulating, reviewing, overseeing, or requiring changes in the safety, sale or marketing of these products.”
Gregory Conley, president of the American Vaping Association, described the omission of the grandfather-date rider as a “modern-day prohibition” of 99.9% of vaping products on the market.
“Congressional leaders have squandered a real opportunity to benefit both public health and small businesses across the country,” he said. “The perverse outcome of this failure to act is that smoke-free vapor products will be treated far more harshly by the FDA than tobacco cigarettes ever have been.”
Siegel noted that it’s possible the White House Office of Management and Budget (OMB) could still require a change to the February 2007 grandfather date in the FDA’s originally proposed deeming regulations. The OMB is currently reviewing the agency’s final draft of the regulations with no timetable for when the regulations will be made public.
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