Durbin, Collins Urge FDA To Follow The Law, Clear The Market Of All Unauthorized Synthetic Vapes Ahead Of July 13th Deadline
In March, Durbin & Collins led effort to pass law giving FDA clear authority to protect children by regulating synthetic nicotine
WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) today led a bipartisan letter with Senator Susan Collins (R-ME) to the Food and Drug Administration (FDA) urging the agency to remove all unauthorized synthetic nicotine e-cigarettes from the market as required by law. Durbin and Collins successfully secured a bipartisan provision in the Fiscal Year 2022 Omnibus Appropriations bill that clarified FDA’s ability to regulate products containing synthetic nicotine as tobacco products. This legislative fix was necessary to close legal loopholes that manufacturers of kid-friendly, flavored e-cigarettes sought to sidestep FDA regulation, which had the potential to erase recent progress made toward curbing the nationwide youth vaping epidemic. The most popular e-cigarette among children today, Puff Bar, uses synthetic nicotine.
The provision, which was supported by FDA, established a clear timeline for synthetic nicotine e-cigarettes to submit applications to FDA—including mandating that any product that did not submit an application by May 14 would be subject to market removal; and any product not authorized by FDA by this Wednesday, July 13, would also be subject to market removal. Recent press reports have revealed that FDA has not taken any enforcement action against synthetic nicotine e-cigarettes that failed to submit timely applications—despite clear statutory authority and a public health duty to do so.
The letter said in part, “In March, Congress gave the Food and Drug Administration (FDA) the clear authority to regulate synthetic nicotine as it does tobacco-derived nicotine, ensuring that all e-cigarettes on the market would be subject to the agency’s public health oversight (Sec. 111 of P.L. 117-103). This bipartisan Congressional action came after FDA sounded the alarm that certain e-cigarette manufacturers were abusing an ambiguity in the law that threatened to upend the agency’s longstanding efforts to regulate vaping products. Despite the agency drawing attention to the need to close this loophole, we are concerned that FDA is failing to implement the law, which has grave consequences for the health of children across America.”
The letter requested FDA answer a number of questions outlined by the Senators regarding the agency’s enforcement actions by July 20th.
The letter continued, “We find it deeply disappointing and unacceptable that FDA appears to be on the brink of failing yet again at protecting our nation’s children from the dangers of nicotine addiction. When presented with an emerging public health challenge identified by FDA, Congress took swift bipartisan action to provide FDA with the tools needed to properly regulate synthetic nicotine. We encourage FDA to immediately use these tools and follow the law.”
FDA’s delays in enforcing its requirements to regulate synthetic nicotine echo similar failures by the agency to complete its review of all other e-cigarettes as required by the U.S. District Court for the District of Maryland. Despite a court order, FDA is now ten months late in finishing its review of these vaping products, leaving dangerous, kid-friendly e-cigarettes still available on store shelves to hook children. Last week, FDA announced an administrative decision to “stay” its marketing denial order of all JUUL Lab Inc.’s products after previously finding these e-cigarettes fail to meet the agency’s public health standard for authorization.
Full text of the letter is available here and below:
July 12, 2022
Dear Commissioner Califf:
In March, Congress gave the Food and Drug Administration (FDA) the clear authority to regulate synthetic nicotine as it does tobacco-derived nicotine, ensuring that all e-cigarettes on the market would be subject to the agency’s public health oversight (Sec. 111 of P.L. 117-103). This bipartisan Congressional action came after FDA sounded the alarm that certain e-cigarette manufacturers were abusing an ambiguity in the law that threatened to upend the agency’s longstanding efforts to regulate vaping products. Despite the agency drawing attention to the need to close this loophole, we are concerned that FDA is failing to implement the law, which has grave consequences for the health of children across America.
The most popular e-cigarette used by children, PuffBar, is a synthetic nicotine vaping product that was reformulated to evade FDA regulation after it was subject to a warning letter from the agency. Additionally, several e-cigarette manufacturers whose applications were subject to marketing denial orders attempted to circumvent the agency’s oversight by switching to synthetic nicotine. In Congressional testimony at the time, you stated, “we’ve got to close this loophole.”
We led the bipartisan effort to close this loophole and establish clear timelines for FDA’s review, which FDA celebrated in public statements and publications.
Recent reporting from STAT News suggests that FDA has failed to take enforcement action against e-cigarette manufacturers that are on the market illegally and failed to submit a timely premarket tobacco product application (PMTA) by May 14, 2022, as required by the new law. Senators also have requested information from FDA on the number of submissions filed, and those inquiries have gone unanswered. This delay and neglect of enforcement is unacceptable—especially considering the youth appeal of many of these e-cigarette products.
This apparent lack of enforcement is particularly shocking given FDA’s previous failure to maintain a list of products that were on the market at the time of the August 8, 2016, deeming rule effective date—a system which would have enabled the agency to understand which products were entering the market without proper authorization. We fear FDA is stumbling down the same path that ignited the youth vaping epidemic in the first place.
Fortunately, there is an opportunity for FDA to rectify these mistakes. The agency has another deadline—July 13, 2022—to clear the market of all unauthorized e-cigarettes that use synthetic nicotine. The law gives FDA the clear authority and duty to remove all unauthorized synthetic nicotine e-cigarettes from the market.
This enforcement delay is not happening in a vacuum. Right now, the agency is 10 months past a court ordered-deadline to finish reviewing PMTAs for all other e-cigarettes that submitted applications by September 9, 2020. To better understand FDA’s plans for implementing the new synthetic nicotine law requirements, we request answers to the following questions by July 20, 2022:
- How many timely filed applications did FDA receive for synthetic nicotine e-cigarettes?
- How many synthetic nicotine e-cigarettes that were on the market by the effective date set forth in subsection (c) of the new law failed to submit timely applications?
- Did the FDA keep a list of synthetic nicotine e-cigarettes that were on the market by the effective date set forth in subsection (c) of the new law?
- What lessons did FDA learn from its failure to keep a list of e-cigarettes that were on the market by August 8, 2016, and are these being employed to implement the synthetic nicotine regulation?
- How many warning letters, and to which companies, has FDA sent to synthetic nicotine e-cigarette manufacturers that failed to submit a timely filed application?
- As set forth in the law, has FDA taken further enforcement action, including injunctions or product seizures, of any such violative synthetic nicotine e-cigarettes?
- Will FDA comply with the law and remove from the market any synthetic nicotine e-cigarettes without a marketing authorization by July 13, 2022?
- Will FDA make public the list of such products?
- Would additional resources enable FDA to improve its e-cigarette enforcement activities?
We find it deeply disappointing and unacceptable that FDA appears to be on the brink of failing yet again at protecting our nation’s children from the dangers of nicotine addiction. When presented with an emerging public health challenge identified by FDA, Congress took swift bipartisan action to provide FDA with the tools needed to properly regulate synthetic nicotine. We encourage FDA to immediately use these tools and follow the law.
Sincerely,
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