Durbin, Senators To Trump Administration: Don't Let Tobacco Companies Evade E-Cigarette Product Review
Durbin And 10 Fellow Democratic Senators Write To Secretary Azar Following His Radio Program Statement Implying The FDA Might Not Review All Vaping Products
WASHINGTON – Today, U.S. Senator Dick Durbin (D-IL), along with 10 of his Democratic Senate colleagues, sent a letter to Department of Health and Human Services (HHS) Secretary Alex Azar requesting clarification on his recent comments made on a radio program regarding Food and Drug Administration (FDA) review of vaping products. Secretary Azar hinted the Trump Administration could create a big loophole for tobacco companies by saying that “not all vaping products” are required to apply for premarket approval from FDA by May of this year—despite a July 2019 federal court order requiring such applications for all new tobacco products.
“It is incredibly alarming that while youth e-cigarette use is skyrocketing, the Trump Administration continues to focus on ideas that would delay and diminish long-overdue steps to hold tobacco companies accountable. In July 2019, a federal judge issued an order requiring that manufacturers submit premarket applications to FDA for deemed new tobacco products by May 12, 2020. In a January 21 interview on an Ohio radio program, you stated that ‘by May of this year, all e-cigarettes – not all vaping products, just e-cigarettes, which are nicotine delivery devices – are required by law to come in and seek FDA approval.’ You also stated the Administration was working ‘to create pathways that would streamline approval for the open-tank, small vape shop-based products.’… It is essential FDA abide by the court’s order, as well as all appropriate statutory and regulatory premarket review requirements for all new tobacco products, including open-tank systems and e-liquids made in small vape shops,” wrote the Senators.
Last week, Durbin, along with 16 other bipartisan Senators, wrote to FDA Commissioner Dr. Stephen Hahn urging him to comply with the agency’s requirements to reject e-cigarette applications that do not protect the public health, upon the FDA’s May 12 deadline for e-cigarette product review. Durbin highlighted concerns with FDA’s ongoing lax 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.
On May 12, due only to a court order, 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.
Today’s letter was also signed by Senators Patty Murray (D-WA), Sherrod Brown (D-OH), Richard Blumenthal (D-CT), Jeanne Shaheen (D-NH), Jack Reed (D-RI), Amy Klobuchar (D-MN), Tina Smith (D-MN), Jeff Merkley (D-OR), Ed Markey (D-MA), and Elizabeth Warren (D-MA).
Full text of today’s letter is available here and below:
February 20, 2020
Dear Secretary Azar:
We write to request clarification of your recent statements on a radio program indicating the U.S. Food and Drug Administration (FDA) may: (1) exclude certain vaping products from a federal court-ordered deadline of May 12, 2020 requiring manufacturers to submit premarket applications for all new tobacco products on the market as of August 8, 2016 that FDA deemed to be subject to the Tobacco Control Act (TCA); and (2) change the standard for obtaining authorization of a premarket tobacco application (PMTA) for certain small vape-shop products. It is incredibly alarming that while youth e-cigarette use is skyrocketing, the Trump Administration continues to focus on ideas that would delay and diminish long-overdue steps to hold tobacco companies accountable.
In July 2019, a federal judge issued an order requiring that manufacturers submit premarket applications to FDA for deemed new tobacco products by May 12, 2020. In a January 21 interview on an Ohio radio program, you stated that “by May of this year, all e-cigarettes – not all vaping products, just e-cigarettes, which are nicotine delivery devices – are required by law to come in and seek FDA approval.” You also stated the Administration was working “to create pathways that would streamline approval for the open-tank, small vape shop-based products.”
These comments raise concerns FDA will inappropriately exclude certain tobacco products from the court-ordered deadline for premarket submissions and will not hold all PMTAs submitted by the deadline to the strict standards in the TCA. It is essential FDA abide by the court’s order, as well as all appropriate statutory and regulatory premarket review requirements for all new tobacco products, including open-tank systems and e-liquids made in small vape shops.
In May 2016, FDA issued a final rule deeming all categories of products that meet the TCA’s definition of “tobacco product” (except accessories) to be subject to the statute’s requirements. As FDA articulated in the deeming rule, the definition encompasses, among other things, all electronic nicotine delivery systems (ENDS) and their “components and parts,” including “[e]-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software.” Accordingly, manufacturers must make premarket submissions to FDA for these and all other products that are deemed new tobacco products by May 12, 2020.
The FDA may not authorize a PMTA unless it meets the statutory requirements of the TCA, including scientific data demonstrating the “tobacco product to be marketed would be appropriate for the protection of the public health.” A PMTA must also contain, among other things, reports of health risk investigations, a complete statement of product ingredients, a complete description of the manufacturing and processing methods, and proposed product labeling. The TCA does not include exceptions for open-tank tobacco products or distinguish “vape shop-based products” from other deemed products. Vape shops that manufacture or modify open-tank ENDS or e-liquids, and thus make new tobacco products, are required to comply with same PMTA requirements as other manufacturers.
We continue to implore the Administration to take serious, appropriate action to curb the youth vaping crisis and protect the public health. As the federal judge explained in his order, this deadline is crucial to addressing the “clear public health emergency” of youth e-cigarette use that is fueled in part by specifically targeted kid-friendly flavors and “a purposeful avoidance by the industry of complying with the premarket requirements despite entreaties from the FDA that it can do so . . . .” The Administration must ensure only new tobacco products for which manufactures have filed applications by the May 12, 2020 deadline remain on the market after that date, and FDA reviews those premarket applications consistent with the TCA.
Accordingly, please provide, by March 5, clarification of your January 21 comments and affirm that FDA will accept and appropriately review PMTAs and all other premarket submissions for deemed new tobacco products, including those that are “open-tank, small vape shop-based products.” If you have any questions, please contact Andi Lipstein Fristedt with Senator Murray’s HELP Committee Staff at 202-224-7675.
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