If you haven’t called your Congressional representative about HR 1136, the FDA Deeming Authority Clarification Act, now’s the time. According to CASAA, the language from the bill has a good chance of being included in the budget bill being written now.
If vapers — and vapor businesses — apply enough pressure on Congress, we could help ensure that the Cole-Bishop bill remains part of the budget. That would mean the bill would not have to find its way through the entire approval process as standalone legislation, a much harder path.
The Cole-Bishop legislation would eliminate the 2007 “grandfather” (or predicate) date as it applies to vapor products. The predicate date forced any product that went to market after Feb. 15, 2007 to go through a difficult approval process, including filing a premarket tobacco application (PMTA) that could cost as much as several million dollars.
Instead, all products that were on the market when the deeming regulations went into effect on August 8, 2016, would be allowed to remain on the market, and only products introduced after that date would be required to go through the PMTA process.
Anti-vaping groups are already in full panic mode over HR 1136. The Campaign for Tobacco-Free Kids, the American Heart Association, the American Academy of Pediatrics, the American Lung Association, and the American Cancer Society’s lobbying arm the Cancer Action Network are leading the opposition to the Cole-Bishop effort, and every public health group in the country will be calling and writing to stop Cole-Bishop. If vapers can’t mobilize for this fight now, we may not have a realistic chance.
The predicate date change will not prevent existing products from having to meet safety and marketing standards imposed by the FDA — despite what our opponents say. It also directs the agency to regulate batteries, and imposes some advertising restrictions, along with product standards, labeling rules, and registration of retailers and manufacturers.
Changing the predicate date would save the vaping industry by removing uncertainty about the future. Many vape businesses have closed already, and many others are planning to close as the August 8, 2018, deadline approaches. Without modernizing the predicate date, the legal vape market will be demolished, and vapers would be forced to turn to the black market — or go back to smoking. Current smokers may never get the chance to try high quality, effective vape products.
The effort to change the deeming predicate date is supported by every major vaping organization, including CASAA, SFATA, VTA, AVA, AEMSA, EVCA, and also the convenience store association NACS. Vaping advocates are 100 percent aligned in the effort to pass the Cole-Bishop bill, or to include it as an amendment in the budget bill. Now it’s really up to vapers to make their voices heard. And it has to happen now.