WASHINGTON -- A Republican and a Democratic congressmen have regrouped in their effort to ease FDA regulation around new tobacco products and vaping back on track.
Congressmen Tom Cole (R-Okla.) and Sanford Bishop (D-Ga.) introduced legislation on Feb. 16 to amend the U.S. Food and Drug Administration’s (FDA) deeming regulations. The proposal would change the predicate date for new tobacco products—the 2007 threshold for tobacco products to avoid new, burdensome scrutiny—as well as introduce other vaping-related initiatives, according to a press release from Cole’s office.
Originally dubbed the Cole-Bishop Amendment last year, the measure got off track when U.S. lawmakers failed to pass a budget last fall, deferring the process until this spring. The new bill restarts that effort.
“With the [pending] change in leadership at the FDA and the renewed push legislatively, we are hopeful that the predicate date will be moved to the 2016 date,” Lyle Beckwith, senior vice president of government relations for NACS, Alexandria, Va., told CSP Daily News.
Named the FDA Deeming Authority Clarification Act of 2017, the legislation would amend the Federal Food, Drug and Cosmetic Act to change the predicate date for tobacco products "deemed" regulated by the FDA, impose licensing and advertising guidelines for vapor products and direct the FDA to establish product standards for vapor-product batteries.
In 2009, the Tobacco Control Act gave the FDA authority to regulate tobacco products under a “deeming process.” Instead of opting to grandfather existing products as of last year, the FDA used the Feb. 15, 2007, predicate date set in the original statute. In doing so, many of today’s vaping products, a majority of which came to market after 2007, are currently subject to a complicated and expensive application process to win FDA approval.
“While there is disagreement about whether certain tobacco products should be regulated or not, there should be agreement that new regulations should apply to products moving forward, and not retroactively,” Cole said. “Inconsistent authority like this will be detrimental and unfair to many manufacturers and businesses. This legislation preserves the FDA’s ability to regulate these products on par with cigarettes, grandfathers currently available products and then requires the FDA’s approval before any new product is introduced.”
“Vapor products offer a promising path for harm reduction for those seeking to quit or limit their smoking,” Bishop said. “This legislation would ensure the FDA’s regulatory process does not limit the availability of safer tobacco options for those seeking to make use of them.”