Is Washington Finally Listening to Vapers?
Before the FDA finalized its deeming rule in 2016, vapers got a rare bit of good news from Congress. The House Appropriations Committee voted 31-19 for an amendment that would change the predicate date for new tobacco products. We called it one small step in the right direction, and a reason for cautious relief.
Short version: The amendment would have spared most vapor products from costly premarket review. It never became law, and vaping products went on to need FDA authorization.
What the amendment would have done
The amendment, introduced by Representative Tom Cole, a Republican from Oklahoma, was part of the agriculture appropriations bill, which funds the US Department of Agriculture and related agencies, including the FDA.
Under the rules as written, any tobacco product that was not on the market on February 15, 2007, would need extensive, expensive testing and FDA review to stay on sale. Very few vaping products existed then, so nearly every e-liquid maker would have faced that process for every flavor. The amendment aimed to move the predicate date to the effective date of the final regulation, the same goal as Cole’s bill, HR 2058.
CASAA, the consumer advocacy group, warned that without a new date, nearly all vapor products then on the market could disappear within two years because of the cost of premarket applications.
Cautious optimism
We liked much of the amendment’s language but had concerns about some of its other provisions, and we couldn’t say how it would interact with the FDA’s coming deeming rule. Because the amendment was not the same as HR 2058, we urged vapers to keep asking their legislators to support that bill too.
Where things stand now
The predicate date never changed. The FDA finalized its deeming rule in 2016, and products already on the market needed applications by September 2020; many are still under review. Our history of the deeming rule covers what happened next, and fda.gov has the current requirements.
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