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WASHINGTON, D.C. — Three federal lawmakers are asking the Food and Drug Administration (FDA) to rethink the proposed grandfather date included in the agency's deeming regulations currently on the table.
The deeming regulations, released in April, would apply to cigars, electronic cigarettes and other tobacco products. The proposed regulations call for a Feb. 15, 2007 grandfather date — the exact date applied to cigarettes — for the newly deemed products.
However, U.S. Reps. John Boehner (R-Ohio), Kevin McCarthy (R-Calif.) and Fred Upton (R-Mich.) recently sent a letter to Sylvia Burwell, secretary of the U.S. Department of Health and Human Services, asking her to consider that date inappropriate for the newly deemed products. The legislators raised concerns that the date will impeded innovation and impose unnecessary regulatory burdens on the FDA and the regulated industries.
The Feb. 15, 2007 date was originally chosen for regulated products because it was the date the Tobacco Control Act was introduced in the 11Oth Congress. Keeping that date in the final deeming rule will create an inequity between currently regulated tobacco products and newly deemed tobacco products, the letter stated.
"Because of the passage of time, many pre-February 15, 2007 cigars are unavailable for regulatory comparison. Additionally, most e-vapor products did not exist at that time, meaning there will be virtually no 'predicate' products in these categories," the legislators explained. "Further, FDA did not even consider e-vapor products to be tobacco products until 2011.
"Even if such 'predicate' products could be found, manufacturers would still be required to file Substantial Equivalence applications with FDA, adding dramatically to FDA's enormous backlog of such applications," the lawmakers added. "As a practical matter, many newly deemed products could be removed from the market. And for those products lacking a 'predicate,' the cost and barriers surrounding a new product submission would largely prevent new entries, posing an unwarranted regulatory barrier to innovation."