The Food and Drug Administration (FDA) this week announced that it is reevaluating its approach to approving nicotine products such as vapes and pouches.
asserted
it → announce → vapes
The Wall Street Journal reports that FDA officials want to "smooth the way for more tobacco products such as flavored vapes to legally enter the market by changing the rules to speed up the authorization process.
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products → report → process
That is good news for manufacturers of nicotine products, who for years have struggled with regulatory bottlenecks, burdensome requirements that do not apply to cigarettes, and long delays in processing their applications for "premarket" approval.
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that → struggle → approval
It is also good news for current and former cigarette smokers, promising to preserve their access to a wide variety of alternatives that are far less hazardous than combusted tobacco.
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that → promise → tobacco
The planned reforms would build on progress that the FDA has made during the last couple of years, including its approval of nicotine pouches and vapes in flavors that former smokers demonstrably prefer.
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smokers → plan → that
Those decisions recognize that concerns about underage use should not override the interests of adults who might want to dramatically reduce their health risks by switching to nicotine habits that do not involve lighting vegetable matter on fire and inhaling the smoke.
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that → recognize → smoke
But if the FDA is serious about tobacco harm reduction, it needs to overhaul a dauntingly complex, expensive, time-consuming, and frustrating system that makes it extremely difficult to legally market such alternatives.
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it → need → alternatives
"The Trump administration is committed to keeping nicotine out of the hands of kids, getting counterfeit vaping products off the streets, and providing safer alternatives for adults who want to quit smoking cigarettes," a Department of Health and Human Services (HHS) spokeswoman told the Journal.
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spokeswoman → commit → Journal
Regulate Smarter, a trade group chaired by former U.S. Sen. Richard Burr (R–N.C.), welcomed the FDA's announcement in an emailed press release, calling it "an encouraging and long-overdue course correction.
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Smarter → chair → it
The need for that correction is clear from a lawsuit that Helix Innovations, an Altria subsidiary that makes nicotine pouches, and NJOY, the company's vape business, filed this month in the U.S. District Court for the Northern District of Texas.
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that → make → Texas
The complaint, which was also joined by two Texas retailers and the Texas Food & Fuel Association, argues that the FDA has failed to "comply with its obligations" under the Family Smoking Prevention and Tobacco Control Act (TCA), the 2009 law that gave the agency regulatory authority over tobacco products.
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that → join → products
That law "expressly requires the FDA to authorize the marketing of new tobacco products (including alternatives to cigarettes) as 'appropriate for the protection of the public health,'" Helix et al. note.
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. → require → health
"To facilitate such authorizations, the statute requires the FDA to grant or deny new product applications as promptly as possible, and 'in no event later than 180 days after the receipt of an application.'"
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statute → facilitate → application
But the FDA "has never complied with this deadline."
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FDA → comply → deadline
The problem was exacerbated in 2016, when the FDA issued a "deeming" rule requiring premarket approval for myriad nicotine products, including vapes.
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FDA → exacerbate → vapes
In response to the resulting backlog, the FDA repeatedly extended application deadlines.
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FDA → result → deadlines
But in May 2019, a federal judge in Maryland nixed those extensions, saying applications would have to be submitted by September 9, 2020, with enforcement against unapproved products delayed for another year.
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enforcement → nix → year
In September 2019, the FDA proposed a rule that "set forth requirements related to the content and format" of premarket applications and "the procedure by which FDA would review" them.
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FDA → propose → them
According to the lawsuit, that rule, which the FDA finalized in October 2021, "disregarded comments, evidence, and obvious alternatives that would have facilitated" the processing of applications.
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that → accord → applications
Under the TCA, a premarket application is supposed to include product samples, proposed labeling, a "full description" of manufacturing and packaging, a "full statement" of the product's ingredients and operation, a "full report" of available information on the product's "health risks," and an "identifying reference" to any relevant FDA standard, along with "adequate information" about the product's compliance with it.
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application → suppose → it
The TCA also says applicants must submit "such other information relevant to the subject matter" that HHS "may require."
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HHS → say → that
The FDA's 2021 rule "made it impossible for the FDA to issue orders on the vast majority of [applications] within 180 days," Helix et al. argue.
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. → make → days
It "did not set forth a viable way for the FDA to timely apply the statutory-authorization criteria to the vast number of new product applications the Deeming Rule required.
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Rule → set → applications
Instead of trying to dig out of the application backlog the FDA had created for itself," the agency "required vast amounts of additional information from applicants—well beyond the TCA's requirements."
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agency → try → requirements
The FDA's demands included "granular descriptions of 'product formulation' that had little to do with any conceivable public health concern," the lawsuit says.
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lawsuit → include → concern
The agency also required "extensive supporting materials," including "all studies concerning" the product's "pharmacological profile" and behavioral data indicating how the product might "affect the tobacco use behavior of both users and nonusers of tobacco products."
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product → require → products
The process mandated by the FDA, critics complained, was "significantly more" demanding than the requirements for approving a new prescription drug or medical device, setting an "impossibly high" bar for manufacturers.
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critics → mandate → manufacturers
And the FDA's procedures guaranteed that processing time would exceed the TCA's 180-day limit.
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time → guarantee → limit
Among other things, the agency said the clock would not start on that limit until it received the "last piece of information necessary to complete the submission."
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it → say → submission
The FDA also broke its process into three components: "acceptance" of an application, a "filing phase," and substantive review.
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FDA → break → application
The agency "would often refuse to accept [an] application on non-substantive grounds," such as "failure to 'comply with the applicable format requirements,'" Helix et al. note.
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. → refuse → requirements
The FDA's forms "sometimes lack the requisite fields for all products," they say, which causes the FDA to refuse acceptance for "purely administrative reasons.
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FDA → lack → reasons
By itself, the "acceptance" phase "often takes longer than the agency's 180-day statutory deadline," the lawsuit says.
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lawsuit → take → deadline
"For example, under the 2021 Final Rule, Helix's [applications] for certain of its [flavored nicotine pouches] were submitted on September 25, 2024, but not 'accepted' until August 12, 2025—321 days later."
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applications → submit → August
Once an application is accepted, the FDA conducts a "filing review" to determine whether it contains "sufficient information to permit a full substantive review."
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it → accept → review
That phase, Helix et al. say, "typically takes even longer than 'acceptance' review."
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. → say → review
And even after "an application had been accepted and filed," the FDA "would sometimes require further information from the applicant—including product samples that applicants offered with their initial submissions" but the FDA refused to accept at that point.
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FDA → accept → point
The FDA, in short, asserted the power to "unilaterally determine when Congress's 180-day review period started."
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period → assert → power
And that, the plaintiffs argue, plainly violates the TCA.
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plaintiffs → argue → TCA
After the FDA proposed the nicotine product regulations but before they were finalized, the court-set deadline for applications resulted in thousands of submissions covering 4.8 million products, mainly nicotine vapes.
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deadline → propose → products
…and 29 more, not listed.
The Aporia
