Agency Misses 120-Day Deadline to Release Tobacco Regulations

WASHINGTON, D.C. -- Like the convenience store and tobacco industries, legislators appear to be frustrated waiting for federal regulation of electronic cigarettes.

On Oct. 1, the Food and Drug Administration (FDA) submitted deeming regulations for tobacco products for review. By executive order, the Office of Information and Regulatory Affairs had 90 days to complete the review, with a possible 30-day extension.

In a letter to President Obama, U.S. Sens. Barbara Boxer (D-Calif.), Richard Blumenthal (D-Conn.), Tom Harkin (D-Iowa), Dick Durbin (D-Ill.), Sherrod Brown (D-Ohio), and Ed Markey (D-Mass.) urged the administration to review and finalize regulations for tobacco products, which may include e-cigarettes and e-hookahs, without further delay.

"In light of the novel products that threaten to addict more youth to nicotine, we ask you to urge the Office of Information and Regulatory Affairs (OIRA) to swiftly release the deeming regulations that it received on Oct. 1, 2013. We are particularly concerned about the risk of addiction posed by new nicotine-based products such as e-cigarettes and 'e-hookahs'," the senators wrote.

The FDA has the authority to draft deeming regulations for tobacco products not spelled out in the Family Smoking Prevention and Tobacco Control Act of 2009. It is widely believed that deeming regulations will cover e-cigarettes.

"While we understand that OIRA is dealing with a number of deadlines, we urge you not to compound the delays that have already occurred over the years since the passage of the Family Smoking Prevention and Tobacco Control Act of 2009," the senators added.

They also raised concerns about what they called the "growing prevalence" of e-cigarette use among youth.

"Many of us have spoken with Food and Drug Administration Commissioner Margaret Hamburg and Center for Tobacco Products Director Mitch Zeller about the urgent need for deeming regulations. We were pleased to see the proposed regulations move from their jurisdiction to OIRA. We hope that you will prioritize the review of these regulations so that we work together to advance appropriate regulatory oversight of e-cigarettes," the letter concluded.

The request comes just weeks after Boxer, Durbin, Harkin, Blumenthal and Markey joined together to back the "Protecting Children from Electronic Cigarette Advertising Act." The measure would permit the Federal Trade Commission (FTC) to determine what constitutes marketing e-cigarettes to children, and would allow the FTC to work with states' attorneys general to enforce the ban, as CSNews Online previously reported.

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