Sen. Susan Collins (R-Maine) added her name to a bipartisan letter (pdf) sent by a group of Senators this week to Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn. In the letter, the Senators urged the commissioner to abide with the agency’s requirements to reject e-cigarette applications that do not protect public health before the FDA’s May deadline for e-cigarette product review.
By May 12, tobacco companies must submit premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration, proving that their products provide an overall benefit to public health. If a company fails to make its case, the FDA has the power to order its products off the market.
The agency will judge that benefit with a two-part test: Are e-cigarettes effective in getting smokers to quit? And, if so, does that benefit outweigh the health damage to new e-cigarette users—including teenagers—who never smoked in the first place?
The Senators raised concerns with the FDA’s past oversight of e-cigarettes and tobacco products and called on the agency to conduct a scientific review that holds the tobacco companies accountable for products that are fueling the epidemic of youth e-cigarette usage.
“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 wrote. “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.”
The lawmakers also pressed the FDA to remove all tobacco products that are out of compliance by the May 12 deadline, including products that do not submit PTMA, products targeted to minors, and flavored cartridge-based products.
“As head of the FDA, your responsibility is to the American public, including, and most important, our nation’s children,” the Senators continued. “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 Family Smoking Prevention and Tobacco Control Act (TCA) bans 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.”
E-cigarette products can remain on the market while the FDA determines whether to approve or reject their applications. The FDA has one year to make these determinations.
The letter was also signed by Senators Dick Durbin (D-Ill.), Lisa Murkowski (R-Alaska), Patty Murray (D-Wash.), Sherrod Brown (D-Ohio), Mitt Romney (R-Utah), Sheldon Whitehouse (D-R.I.), Elizabeth Warren (D-Mass.), Tammy Baldwin (D-Wis.), Jack Reed (D-R.I.), Richard Blumenthal (D-Conn.), Jeanne Shaheen (D-N.H.), Ed Markey (D-Mass.), Jeff Merkley (D-Ore.), Maggie Hassan (D-N.H.), Ron Wyden (D-Ore.), and Tom Udall (D-N.M.).