New Bill Would Save Vaping Industry from FDA Prohibition

WASHINGTON, DC — Yesterday, Reps. Tom Cole (R-OK) and Sanford Bishop (D-GA) introduced a bill that would stop the FDA from banning 99%-plus of vapor products on the market today. The bill, the FDA Deeming Authority Clarification Act of 2017, would both save over 10,000 small businesses from closure and lay the groundwork for reasonable FDA regulation of these innovative technology products.

Under the FDA’s current rules, every vapor product that has come to the market since a predicate date of February 15, 2007 — all products on the market today — will be required to file a multi-million dollar “pre-market” application by August 8, 2018. For the thousands of companies that cannot afford this process, their products will become illegal on that date.

If this bill becomes law, the new predicate date will be August 8, 2016, the date on which the FDA finalized their rule “deeming” vapor products to be tobacco products. Furthermore, the bill would require the FDA to take action on several new regulatory measures, including setting battery standards, requiring registration of vapor product retailers, and limiting print advertising to reduce youth exposure to vapor products.

The bill builds upon the Cole-Bishop Amendment, a rider that was previously added to the FY 2017 Agriculture Appropriations bill. After the election of President Donald Trump, Congress passed a Continuing Resolution that delayed the budget process, which temporarily put that provision on hold.

“With Republicans now in control of Congress and the White House, there is no better time for action on this issue,” said Gregory Conley, President of the American Vaping Association. “This Obama-era rule will be devastating to small businesses and harm public health by dramatically reducing consumer access to products that are widely agreed to be far less harmful than smoking.”

Conley is encouraging vapers and small business owners to renew their efforts to contact Congress to gain support for modernizing the predicate date.

“Many members of Congress do not realize the number of jobs and lives that will be impacted by a failure to take action on this issue,” said Conley. “Adding cosponsors to this bill, as well as getting a Senate companion introduced, is critical to ensuring that this bill becomes law.”

The bipartisan sponsors of the bill also commented.

“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,” said Rep. Cole. “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 part 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,” said Rep. Bishop. “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.”

Last year, the Royal College of Physicians released a landmark study estimating vaping to be at least 95% less harmful than smoking.  Additionally, just last month, the University of Victoria’s Center for Addictions Research of BC published a report strongly disputing the idea that vaping is acting as a gateway to smoking for adolescents.