E-cigarette advocates call omission a “modern-day prohibition”
By Melissa Vonder Haar, Tobacco Editor, CSP
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.
“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.”