Proposed Bill Seeks to Clear Air on FDA Deeming Rule

WASHINGTON, D.C. — Two federal lawmakers have proposed a measure to help as the tobacco industry continues to get a grasp on new regulations for other tobacco products like electronic cigarettes, cigars and pipe tobacco.

U.S. Reps. Tom Cole (R-Okla.) and Sanford Bishop (D-Ga.) introduced legislation to ensure sensible regulations for newly deemed tobacco products by the Food and Drug Administration (FDA). 

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 newly deemed tobacco products, impose common-sense licensing and advertising guidelines for vapor products, and direct the FDA to establish product standards for vapor product batteries.

The final deeming rule went into effect on last summer. A major sticking point has been the Feb. 15, 2007 predicate date — also known as the grandfather date. Some argue the date, which is the same included in the Family Smoking Prevention and Tobacco Control Act of 2009, would be especially tough on the e-cigarette and vapor industry since few, if any, products were on the market by that date.

The Tobacco Control Act, which was signed into law in June 2009, gives the FDA the authority to regulate tobacco products.

According to the lawmakers, without the proposed legislation, the FDA effectively is making it more difficult for vapor products to come to market than cigarettes. The measure builds on the Cole-Bishop Amendment which was included in the House version of the Fiscal Year 2017 Agriculture Appropriations Bill.

"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 part with cigarettes, grandfathers currently available products and then requires the FDA's approval before any new product is introduced," he explained.

The FDA Deeming Authority Clarification Act of 2017 proposes to move the predicate date for newly deemed products to Aug, 8, 2016 — the date the final deeming rule went into effect.

"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."
 
The American Vaping Association (AVA) applauded the legislation, adding the bill would both save more than 10,000 small businesses from closure and lay the groundwork for reasonable FDA regulation of these innovative technology products.

"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 AVA. "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 urged 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," Conley said. "Adding cosponsors to this bill, as well as getting a Senate companion introduced, is critical to ensuring that this bill becomes law."

To read more about the FDA Deeming Authority Clarification Act, click here.