Washington, D.C.—U.S. Senator Susan Collins joined a bipartisan group of Senators this week in sending a letter to Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn. The Senators urged him to comply with the agency’s requirements to reject e-cigarette applications that do not protect public health upon the FDA’s May 12 deadline for e-cigarette product review. The Senators also highlighted concerns with FDA’s oversight of e-cigarettes and tobacco products and pressed the agency for a science-based review that holds the industry accountable for products that are responsible for fueling the youth e-cigarette epidemic.
“As head of the FDA, your responsibility is to the American public, including, and most important, our nation’s children,” the Senators wrote. “As you know, five million children are now vaping, including one in four high school students—an increase of 135 percent over the past two years alone … we do not believe that a product that has increased or is likely to increase youth use of nicotine or tobacco can meet the public health standard required under the [law].”
The Senators also urged FDA to remove from the market all tobacco products that are out of compliance with its January 2 guidance or the May 12 deadline, including products that do not submit premarket tobacco product applications (PMTAs), flavored cartridge-based products, and products that appeal to or are targeted to minors.
“We want FDA to succeed in carrying out its statutory mandate to regulate tobacco products, but are concerned based upon past oversight activities that FDA will not deny a PMTA application for a tobacco product that is not appropriate for the protection of public health.” the Senators continued. “We call on you to keep the commitment you made in your Congressional testimony to be guided by “science, data, and the law,” by evaluating how a certain e-cigarette product has been used by children in the time preceding the May 12 submission.”
On May 12, all e-cigarette manufacturers will be required to submit product applications to the FDA in order to be allowed on the market. If an e-cigarette company wants to keep or put any new device or flavor product onto the market, they must submit an application to the FDA, including for products recently banned (such as certain flavored JUUL pods). E-cigarette products can remain on the market while FDA determines whether to approve or reject their applications. FDA has one year to make these determinations.
The Family Smoking Prevention and Tobacco Control Act (TCA) prohibits any new tobacco products, including e-cigarettes, from entering the U.S. market unless the FDA determines that there is “a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health.”
The letter is also signed by Senators Dick Durbin (D-IL), Lisa Murkowski (R-AK), Patty Murray (D-WA), Sherrod Brown (D-OH), Mitt Romney (R-UT), Sheldon Whitehouse (D-RI), Elizabeth Warren (D-MA), Tammy Baldwin (D-WI), Jack Reed (D-RI), Richard Blumenthal (D-CT), Jeanne Shaheen (D-NH), Ed Markey (D-MA), Jeff Merkley (D-OR), Maggie Hassan (D-NH), Ron Wyden (D-OR), and Tom Udall (D-NM).
Click here to read the full-text of the letter.