WASHINGTON --Many have suggested that the deeming regulations proposed by the U.S. Food and Drug Administration (FDA) in April were lax on the growing electronic cigarette and vaping industry, due to the lack of bans on flavors, open systems or internet sales. Gregory Conley, president of the American Vaping Association (AVA), argues that the expensive process of the Pre-Market Tobacco Applications (PMTA) required under the proposed regulations "will effectively ban 99.9% of vapor products."
"Virtually every single vaping product will require a PMTA," Conley said during last week's CSP-hosted Vaping Academy in Phoenix. "The bare minimum I've been told is $1 million to $1.5 million, others believe it will be $5 million to $10 million-plus because the FDA will do everything in their power to stop, for example, any flavored products to come to market."
Companies will have two years after the deeming regulations go into effect to submit a PMTA, but Conley calls the two-year window "a delay in execution," especially since the FDA has yet to accept a single PMTA application since the advent of the new product pathway in 2009.
As such, the AVA and other vaping advocates have called for a change to the "grandfather date" for products to qualify for substantial equivalence (SE). Pursuant to the Tobacco Control Act of 2009, a new product can win SE approval through a much less rigorous review if there was a similar predicate product on the market by February 2007. Because electronic cigarettes and vaping products were virtually nonexistent in 2007, Conley believes a later date should be established for the segment.
"The FDA's position?" Conley said. "'Congress gave us that date so we can't change it'."
Now it appears that Congress is actually asking the FDA to change that date: Conley cited a letter sent to Health and Human Services (HHS) Secretary Sylvia Burwell last week by House Speaker John Boehner (R-Ohio), House Majority Leader Kevin McCarthy (R-Calif.), and House Energy and Commerce Committee Chairman Fred Upton (R-Mich.).
"Most e-vapor products did not exist at that time," the letter reads. "FDA did not even consider e-vapor products to be tobacco products until 2011. As a practical matter, many newly deemed products could be removed from the market."
The House leaders went on to request that existing electronic cigarette and vaping products be allowed to remain on the market and that the SE grandfather date be pushed back to either the date when the deeming regulations were first proposed (April 2014) or the date the rules go into effect.
"We'll see what happens there," Conley said. "I think HHS will come back and say 'we don't have the authority to change the day' then maybe we'll see a bill introduced in Congress to change the grandfather date."
"It should sail through the House," he continued. "The question is do we get four, five, six Democrats in the Senate to join the Republicans in breaking the filibuster and saving this industry?"
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