03/09/22

Due to ongoing FDA delays, bipartisan group of Senators raise alarm over kid-friendly, addictive e-cigarettes on the market without regulation

WASHINGTON – US Senate Majority Whip Dick Durbin (D-IL) today led a bipartisan letter with Senator Mitt Romney (R-UT) and 13 other Senators to Food and Drug Administration (FDA) Commissioner Robert Califf urging the FDA to end its delays in reviewing premarket tobacco product applications (PMTAs) for the e-cigarette products that have fueled the youth vaping epidemic. In the letter, the Senators reiterated that the deadline for FDA’s review was six months ago as mandated by a US District Court Judge for the District of Maryland.

FDA is still evaluating applications for JUUL and several other flavored e-cigarettes most responsible for hooking children, despite a September 9, 2021, court deadline to complete the review. The FDA has not issued a marketing order or denial for any product since October 2021. FDA’s long-overdue decisions on the PMTA applications will determine the course of the youth vaping epidemic, as e-cigarette manufacturers are required to demonstrate to FDA their products are appropriate for the protection of public health.

“Contrary to its initial plan, FDA has not prioritized review of e-cigarettes with the largest market share and therefore greatest public health implication. Instead, it has deferred its decisions on the most critical applications — including for those products that are most popular with youth — to the end. As a result, six months after FDA was supposed to have completed its reviews, e-cigarettes that hold the greatest potential harm to public health remain unreviewed and on the market, ” the Senators wrote.

Today’s letter builds upon an important bipartisan provision that Durbin and many of the letter’s co-signers led in the fiscal year 2022 Omnibus appropriations bill to clarify FDA’s authority over e-cigarettes’ synthetic nicotine. Together, these actions will protect public health by improving FDA’s enforcement against vaping products targeting children.

The FDA’s and Centers for Disease Control (CDC) and Prevention’s National Youth Tobacco Survey found that more than two million youth used e-cigarettes in 2021. The National Institute on Drug Abuse’s Monitoring the Future survey found that 19.6 percent of high school seniors used e -cigarettes last year. Approximately 85 percent of youth e-cigarette users report using flavored products.

“Now that FDA is six months past the court deadline, these unreviewed products are only being permitted to stay on the market due to the agency exercising enforcement discretion. It makes no sense, and runs contrary to the Tobacco Control Act’s statory framework, that products that have not been granted authorization are being allowed to stay on the market and attract new, young users. FDA has the authority and responsibility to halt this grace period today and restore the statory burden of proof on manufacturers to demonstrate their product is “appropriate for the protection of public health” prior to market entrance, “ the Senators continued.

While the letter applauded FDA’s decision to not authorize any e-cigarette flavors other than tobacco, the Senators pressed FDA to continue to apply this standard as it completes its review of other flavored e-cigarettes, including menthol-flavored e-cigarettes.

“We hope FDA continues to apply this standard as it completes its review of other flavored e-cigarettes, including menthol-flavored e-cigarettes. We are concerned that if FDA were to authorize one or more flavored e-cigarettes, youth would simply switch to those products. This is not a theoretical concern. When FDA removed certain flavored e-cigarettes from the market in 2020, youth migrated to those flavored products that remained on the market. FDA’s game of whack-a-mole does not work, “ the Senators continued.

The Senators also listed a number of steps Califf can take as the new FDA commissioner. They urged Califf to promptly complete review of all pending e-cigarette applications; continue to rigorously apply the statory standard for authorizing any e-cigarette and issue denial orders for all flavored products, including menthol-flavored e-cigarettes; cease FDA’s illogical discretion and immediately prioritize enforcement against the flavored e-cigarettes with the largest market share and those most popular with youth that continue to be sold without authorization, including those with pending applications; and ensure that all e-cigarettes receiving denial orders are quickly removed from the market.

“It is our hope and expectation that you can bring a new approach and commitment to using all of FDA’s tools and prioritizing public health to protect youth from the harms of tobacco and nicotine,” the Senators concluded.

Along with Durbin and Romney, the letter was also signed by Senators Tammy Duckworth (D-IL), Sherrod Brown (D-OH), Tammy Baldwin (D-WI), Ron Wyden (D-OR), Elizabeth Warren (D- MA), Tina Smith (D-MN), Ed Markey (D-MA), Richard Blumenthal (D-CT), Jack Reed (D-RI), Jeanne Shaheen (D-NH), Jeff Merkley (D-OR) , Maggie Hassan (D-NH), and Sheldon Whitehouse (D-RI).

Full text of the letter is available here and below:

March 9, 2022

Dear Commissioner Califf:

We are writing to express our deep concern that the Food and Drug Administration (FDA) is now six months overdue in fulfilling a court order to complete its premarket review of e-cigarettes and other deemed tobacco products. Because of this ongoing delay, the most popular e-cigarettes — including JUUL and other flavored products most responsible for addicting children — remain on the market.

This current six-month delay follows after the US District Court for the District of Maryland found that FDA, “decided not to enforce the premarket review provisions at all…”. It is unacceptable that, despite having the authorities to regulate e-cigarettes, the FDA has pursued a course of inaction that has fueled the youth vaping epidemic. We urge the agency to promptly complete its review of the remaining tobacco product applications, appropriately apply the statory “appropriate for the protection of public health” standard to reject flavored products, and remove e-cigarette products that do not have an authorization from the market .

We recognize that FDA received a very large number of applications and commend the agency for completing work on the vast majority of them, including rejecting millions of flagrantly kid-friendly flavored e-cigarettes. But FDA has not completed its reviews by the court deadline of September 9, 2021, and is permitting unreviewed products to remain on the market, leaving children at risk of getting hooked on these e-cigarettes.

Contrary to its initial plan, FDA has not prioritized review of e-cigarettes with the largest market share and therefore greatest public health implication. Instead, it has deferred its decisions on the most critical applications — including for those products that are most popular with youth — to the end. As a result, six months after FDA was supposed to have completed its reviews, e-cigarettes that hold the greatest potential harm to public health remain unreviewed and on the market. In fact, the FDA has not issued a marketing order or denial for any product since October!

Now that FDA is six months past the court deadline, these unreviewed products are only being permitted to stay on the market due to the agency exercising enforcement discretion. It makes no sense, and runs contrary to the Tobacco Control Act’s statory framework, that products that have not been granted authorization are being allowed to stay on the market and attract new, young users. FDA has the authority and responsibility to halt this grace period today and restore the statory burden of proof on manufacturers to demonstrate their product is “appropriate for the protection of public health” prior to market entrance.

Flavored e-cigarettes remain unreviewed and on the market despite evidence that youth use e-cigarettes at high rates and that flavors are a primary reason why youth use e-cigarettes. The FDA’s and Centers for Disease Control and Prevention’s National Youth Tobacco Survey found that more than two million youth used e-cigarettes in 2021. The National Institute on Drug Abuse’s Monitoring the Future survey found that 19.6 percent of high school seniors used e-cigarettes last year. Flavors are a major reason. Approximately 85 percent of youth e-cigarette users report using flavored products, and 70 percent of youth e-cigarette users say they use e-cigarettes “because they come in flavors I like.”

We are pleased that, so far, FDA has not authorized any e-cigarette with flavors other than tobacco. For the premarket reviews that FDA has completed, the agency has correctly recognized that flavored e-cigarettes appeal to youth and has appropriately required manufacturers that want to continue to sell flavored e-cigarettes to provide “robust and reliable evidence” demonstrating that their potential benefit to adult smokers outweighs the significant known risks to youth.

We hope FDA continues to apply this standard as it completes its review of other flavored e-cigarettes, including menthol-flavored e-cigarettes. We are concerned that if FDA were to authorize one or more flavored e-cigarettes, youth would simply switch to those products. This is not a theoretical concern. When FDA removed certain flavored e-cigarettes from the market in 2020, youth migrated to those flavored products that remained on the market. FDA’s game of whack-a-mole does not work.

After being sworn in as FDA’s new Commissioner, you identified tobacco regulation as one of your priorities. There are a number of steps you can take that will protect kids from the dangers of e-cigarettes. We urge you to do the following:

  • Promptly complete review of all pending e-cigarette applications, including products with the largest market share and those most popular with youth;
  • Continue to rigorously apply the statory standard for authorizing any e-cigarette and issue denial orders for all flavored products, including menthol-flavored e-cigarettes;
  • Cease FDA’s illogical discretion and immediately prioritize enforcement against the flavored e-cigarettes with the largest market share and those most popular with youth that continue to be sold without authorization, including those with pending applications; and
  • Ensure that all e-cigarettes receiving denial orders are quickly removed from the market.

Thank you for your attention to this matter. Many of us raised these issues in our meetings with you prior to your confirmation. It is our hope and expectation that you can bring a new approach and commitment to using all of FDA’s tools and prioritizing public health to protect youth from the harms of tobacco and nicotine.

Sincerely,

-thirty-

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