The Cole-Bishop Amendment to the FDA e-cig regulations was passed by the U.S. House of Representatives in April of 2015, but getting through the Senate has proven a more difficult battle. The bill introduced by Rep. Sanford Bishop (D - GA) and Rep. Tom Cole (R - OK) attempts to redefine the controversial predicate date of February 15, 2007.
The amendment was slated to be included as a line item in the new federal budget being voted upon just this month. However, due to a somewhat bumpy transitional period for the incoming President-Elect and the consistent gridlock on Capitol Hill, the final budget package of the Obama Administration was not approved. Instead, the Senate passed an alternative mini-budget, providing just enough money to keep the federal government running until April 25, 2017. The Cole-Bishop Amendment didn’t make the cut.
What’s next for the Cole-Bishop Amendment?
But the vaping industry still has hope. The amendment is expected to be included in the first budget package offered by the Trump Administration shortly after Inauguration Day on January 20.
Furthermore, Donald Trump has selected Tom Price to be the new Secretary of the Department of Health and Human Service, the cabinet position responsible for overseeing the FDA. Price is considered a friend of the vaping community for his vocal opposition to the Family Smoking Prevention and Tobacco Control Act, the Obama-approved legislation that essentially led to the FDA deeming regulations in the first place.
Meanwhile, long-time associate of NJOY investor and PayPal Founder Peter Theil is expected to be Trump’s pick to run the FDA itself. Jim O’Neil is also considered very vape-friendly. With Price and O-Neill expected to be heavily involved in crafting the first federal budget of the Trump Administration, vapers are expecting the Cole-Bishop Amendment to receive the full support and power of the Trump White House for Senate Approval in early 2017.
The Cole-Bishop Amendment will not overturn the FDA deeming regulations entirely, but its passage is a critical milestone in the War on Vaping. According to the new rules, e-cigs, vaping technology, and all related components manufactured after the predicate date of February 15, 2007 must adhere to a million-dollar Pre-Market Tobacco Application (PMTA) process that is time-consuming and extremely complex.
Even though vape shops are being given almost two full years to comply with the PMTA process, the FDA deeming regulations in their current state threaten to wipe out thousands of small businesses by 2018. The Cole-Bishop Amendment wants to move this date forward by more than eight years.
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