On One Year Anniversary of FDA Failing To Meet Court-Ordered Deadline To Regulate E-Cigarette Products, Durbin Urges HHS To Step In
WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) today sent a letter to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf and Department of Health and Human Services (HHS) Secretary Xavier Becerra condemning the FDA for its failure to meet e-cigarette and synthetic nicotine deadlines, unwillingness to take action against companies that defy the agency’s orders, and general lack of urgency when it comes to protecting children from the harms of tobacco and nicotine use. The court-ordered deadline for FDA to finish reviewing e-cigarette applications was September 9, 2021, exactly one year ago today, and yet the agency has only completed reviews of about half of those e-cigarettes with submitted applications that represent a large share of the market —leaving dangerous, kid-friendly e-cigarettes available on store shelves to hook children.
In the period of time during which the FDA has defied a court order to regulate all e-cigarettes on the market, the Truth Initiative estimates that nearly two and a half million children and young adults have begun using vaping products.
Durbin said in part, “I am deeply concerned that FDA has not taken the steps necessary to complete these premarket reviews and to remove unauthorized products from the market. Youth e-cigarette use remains a serious public health problem, and FDA’s inadequate response is leaving our kids at risk… Further, the agency has continued to state in court filings that it does not expect to complete review of the most popular e-cigarette products until the end of June 2023—nearly three years after the court-ordered deadline for manufacturers to submit applications, and nearly two years after the deadline established by the court for FDA to have completed those reviews. As a result of these harmful delays—and FDA’s refusal to use its authority to remove e-cigarette products from the market until reviews are complete—many unauthorized e-cigarettes that are attractive to kids remain on the market. Of note, FDA has only completed reviews of about half of those e-cigarettes with submitted applications that represent a large share of the market.”
Further, Durbin criticized FDA for not taking action against e-cigarette and synthetic nicotine products that flout FDA orders, and called on HHS to step in and take on a more robust role in protecting children from vaping products. A recent STAT News investigation reviewed 120 denial letters that FDA sent to vaping companies between August 2021 and May 2022, ordering their products off the market. The investigation found that at least 139 of these products—more than 50 percent of the products named in those warning letters—are still being sold in the United States.
Durbin continued, “The FDA has sweeping legal authority—granted to it by Congress—to crack down on e-cigarette companies that ignore denial orders, including the ability to impose seven-figure fines and physically remove products from the market. Yet, inexplicably, FDA has never used those powers against illegally marketed e-cigarettes. The agency has further refused to use its power and authority—and legal mandate—to regulate the synthetic nicotine marketplace… If the FDA cannot, or will not, do its job, then it is time for the Department of Health and Human Services (HHS) to step in. Millions of children nationwide are now addicted to nicotine because of e-cigarettes and synthetic nicotine products. How many millions more must become addicted before our public health agencies act?”
In March, Durbin led a bipartisan letter with 14 of his colleagues calling on FDA to finish its review of e-cigarettes immediately; reject applications for e-cigarettes, especially kid-friendly flavors, that do not prove they will benefit the public health; and clear the market of all unapproved e-cigarettes. The letters build 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.
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.
Full text of the letter is available here and below:
September 9, 2022
Dear Secretary Becerra and Commissioner Califf:
One year.
Earlier this week, JUUL Labs—arguably the company most responsible for what one former Food and Drug Administration (FDA) Commissioner dubbed our nation’s “youth vaping epidemic”—tentatively agreed to pay nearly $440 million to nearly three dozen states suing over the company’s marketing and sales practices, which targeted children nationwide. Attorneys General in those states did not cower to JUUL’s legal prowess or its cadre of former FDA officials now on payroll. Instead, they saw a company that was preying on children, and they acted decisively—an approach that seems foreign to the FDA.
As of today, the FDA is exactly one year overdue in fulfilling a court order to complete its premarket review of e-cigarette products, including JUUL. I am deeply concerned that FDA has not taken the steps necessary to complete these premarket reviews and to remove unauthorized products from the market. Youth e-cigarette use remains a serious public health problem, and FDA’s inadequate response is leaving our kids at risk.
In 2019, the U.S. District Court for the District of Maryland found that FDA had acted without legal authority by suspending operation of the premarket review requirements of the Family Smoking Prevention and Tobacco Control Act and set a deadline of September 9, 2020, for manufacturers to submit premarket applications. Under the court’s order, products for which applications were filed timely could remain on the market for up to one additional year during FDA’s review. FDA is now one year past the court-ordered deadline to complete its premarket reviews.
One year.
Further, the agency has continued to state in court filings that it does not expect to complete review of the most popular e-cigarette products until the end of June 2023—nearly three years after the court-ordered deadline for manufacturers to submit applications, and nearly two years after the deadline established by the court for FDA to have completed those reviews. As a result of these harmful delays—and FDA’s refusal to use its authority to remove e-cigarette products from the market until reviews are complete—many unauthorized e-cigarettes that are attractive to kids remain on the market. Of note, FDA has only completed reviews of about half of those e-cigarettes with submitted applications that represent a large share of the market. This inaction has real life consequences—with the Truth Initiative estimating that nearly two and a half million children and young adults have begun using vaping products over the past year.
It is bad enough that FDA is now one year delinquent in finalizing review of e-cigarette applications, but it appears as though—even when FDA has actually completed review of a product and denied an application—many vaping companies regularly flout the agency’s orders. And FDA does nothing to stop them. A recent STAT News investigation reviewed 120 denial letters that FDA sent to vaping companies between August 2021 and May 2022, ordering their products off the market. The investigation found that at least 139 of these products—more than 50 percent of the products named in those warning letters—are still being sold in the United States. The FDA has sweeping legal authority—granted to it by Congress—to crack down on e-cigarette companies that ignore denial orders, including the ability to impose seven-figure fines and physically remove products from the market. Yet, inexplicably, FDA has never used those powers against illegally marketed e-cigarettes.
The agency has further refused to use its power and authority—and legal mandate—to regulate the synthetic nicotine marketplace. Many companies, such as PuffBar, developed kid-friendly flavored synthetic nicotine products in an attempt to evade FDA regulation. When Congress became aware of this problem, and at FDA’s request, we acted—passing a law that requires synthetic nicotine products to receive FDA authorization in order to remain on the market. The deadline for FDA to complete review of synthetic nicotine products came and went on July 13, nearly two months ago. To my knowledge, not a single synthetic nicotine product has been authorized, and yet these illegally marketed products remain widely available in a plethora of flavors on store shelves nationwide.
The FDA continues to fail our children with its missed deadlines, failure to enforce orders, and general lack of urgency with respect to e-cigarettes and synthetic nicotine products. For years, a bipartisan chorus of Senators and Representatives have been sounding the alarm about the dangers of these products to our children, while FDA action has been too slow or, in many instances, completely non-existent. If the FDA cannot, or will not, do its job, then it is time for the Department of Health and Human Services (HHS) to step in. Millions of children nationwide are now addicted to nicotine because of e-cigarettes and synthetic nicotine products. How many millions more must become addicted before our public health agencies act?
Sincerely,
-30-