Following The Two-Year Anniversary of FDA Failing to Regulate Unlawfully Marketed Vaping Products, Durbin Again Urges FDA, DOJ to Act

Letter

Dear Commissioner Califf:

Happy second anniversary. It's been two years. Today marks the two-year anniversary
of a federal court-ordered deadline for the Food and Drug Administration (FDA) to complete its
long-overdue review of pre-market tobacco product applications (PMTAs) from e-cigarette
manufacturers. The failure of FDA to meet this court-ordered deadline jeopardizes public health
and raises significant legal questions about the agency's compliance with the Tobacco Control
Act. Based on published research, retail sales data, and public health surveys, an estimate of
approximately two million children may have picked up vaping in the time since FDA missed its
September 9, 2021, deadline. It is unacceptable for a federal agency to be so delinquent in
complying with a federal court order, especially given the inexcusable harm it has caused to
America's children.

Since FDA missed the court's deadline two years ago, I have sent eight letters raising key
questions about FDA's regulatory review process and enforcement actions. You and I have met
and spoken by phone several times. And a July 26, 2023, letter from public health leaders
representing 24 of the nation's largest cities pleaded with FDA to shut down domestic
distribution of unauthorized e-cigarettes that are filling store shelves across the country. Despite
these efforts, FDA has failed to meaningfully act. It is unclear what--if anything--will finally
prompt FDA to get its act together and take more seriously the risk of the tobacco industry
addicting a new generation of kids.

While I commend FDA for processing millions of PMTAs--including rejecting
thousands of flagrantly kid-friendly flavored products--the failure to police the market fully has
rendered FDA's regulatory review almost meaningless. Under the Tobacco Control Act,
manufacturers are required to demonstrate their product is "appropriate for the protection of
public health" prior to entering the market. This has not happened. Despite the clear
requirements under the law, thousands of unauthorized and addictive e-cigarettes currently are
peddled to children every day because FDA refuses to enforce violations of the law.

A scathing independent report from the Reagan-Udall Foundation in December 2022
found that FDA's "failure to take timely enforcement action jeopardizes public health and
undermines credibility and effectiveness in tobacco product regulation," and that "the Agency
has not been transparent regarding the reasons it has failed to clear the market of illegal
products." Following this report, FDA announced on February 24, 2023, its plan to hold a joint
"summit" with the Department of Justice (DOJ) and other stakeholders to improve enforcement
actions. If any such summit has even been scheduled or taken place, I am not aware of any
readout, outcomes, or even participant list.

I have written to DOJ and spoken directly with Attorney General Garland about these
enforcement failures and the need for enhanced interagency collaboration. An encouraging
example was FDA's recent import alert for Elf Bar and Esco Bars, subjecting these e-cigarettes,
which are unauthorized and extremely popular among children, to detention without physical
examination at the time of entry. And while FDA, together with DOJ, has now used its civil
monetary penalty (CMP) and injunction authorities in some two-dozen limited circumstances, it
simply is not credible to suggest that this makes a dent in the flagrantly illegal products being
sold to children.

My office has investigated FDA's public data files to identify e-cigarette manufacturers
who have received both marketing denial orders and warning letters yet continue to sell
unauthorized products, in order to assess FDA's effectiveness in taking enforcement action
against some of the most obviously defiant examples. Our examination found at least 22 vaping
products that currently appear to be sold online by the manufacturer--in violation of the law--
and in defiance of repeated enforcement actions by FDA. In addition to those products sold
online by the manufacturer, several other such products remain available for purchase from thirdparty retailers. This includes Breeze Smoke, which was found by the Centers for Disease
Control and Prevention (CDC) to be among the top-five highest selling e-cigarettes in America.
These products we identified are only the tip of the iceberg--our review excluded products that
have a pending PMTA, that have a PMTA that FDA refused to file or accept, that never
submitted PMTAs, or are sold exclusively in brick and mortar stores.

These appear to be flagrant examples of e-cigarette companies flouting FDA rules that
are ripe for additional penalties, and yet FDA has not acted. In response to my March 16, 2023,
inquiry, DOJ stated that, "FDA is not required to give notice to or receive approval from the
Department before issuing such warning letters or civil monetary penalties." It is not clear why
in these instances FDA has not used its authority to issue CMPs. In the continued absence of
FDA action, my office has referred these cases to DOJ for review and potential enforcement
action.

Further, my investigation found that FDA has only issued "closeout letters" to 10 percent
of the 685 tobacco warning letters it has issued since January 1, 2021. A closeout letter indicates
that FDA has verified that corrective action has taken place to address the violations contained in
the warning letter. The fact that such a small percentage of warning letters have received
closeout letters indicates that these violations have not been remedied adequately, and that the
public health threat persists. It also appears to run contrary to FDA's claims that "many
[companies] come into compliance after receiving a warning letter."

When FDA sounded the alarm in 2021 about new synthetic nicotine vaping products that
were utilizing a regulatory loophole to evade FDA regulation, I led the swift, bipartisan effort to
pass a law to subject these products to FDA's authority. Any synthetic nicotine vape that failed

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to receive authorization by July 13, 2022, is now considered to be on the market illegally. That
deadline was more than one year ago. Yet, despite obtaining new authority to regulate these
vaping products, FDA has not fulfilled its duty--leaving some of the most popular e-cigarettes
among children on the market without authorization. That is unacceptable and, frankly,
infuriating.

With these synthetic nicotine products--as with other e-cigarettes--the question of
whether or not a product has a pending PMTA should have no bearing on FDA's enforcement.
For all unauthorized e-cigarettes on store shelves in 2023, the Tobacco Control Act does not
provide a safe harbor for the mere fact that a PMTA is pending. The law sets forth a clear
premarket framework. DOJ has stated to me that the "Department has no formal policy
regarding enforcement discretion with respect to e-cigarette companies that have not obtained
marketing authorization." These products are on the market illegally and pose a significant
public health threat, yet FDA has repeatedly and inexplicably shied away from using its full
arsenal of enforcement tools granted to the agency by Congress.

For years, you and FDA leadership have sought to distract from or justify your failures to
protect children from being preyed upon by Big Tobacco by touting something around the
corner: needing to close the synthetic loophole; a Reagan-Udall review; a summit with DOJ;
time for a new Center for Tobacco Products Director to get acclimated. Meanwhile, FDA has
missed a federal court deadline by two years, and the problem has only grown worse: the CDC
found a 46 percent increase in the number of e-cigarette brands on the market between 2020 and
2022. If you are unwilling to meet this moment, perhaps FDA requires new leadership.

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