Court Ruling Upends FDA’s E-Cigarette Review Schedule

Vacates previous agency guidance and requires new product deadlines
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WASHINGTON — The U.S. Food and Drug Administration (FDA) is reviewing a ruling by U.S. Judge Paul Grimm that vacates the agency’s August 2017 guidance that extended the deadlines for tobacco product manufacturers to apply for and obtain approval to market certain tobacco products, including electronic cigarettes. The ruling also resets the clock on that review process.

The American Academy of Pediatrics, the American Cancer Society, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids and other public health groups filed the lawsuit against the FDA in Maryland in March 2018.

Grimm of the U.S. District Court for the District of Maryland on May 15 denied the defendant’s motion to dismiss the lawsuit and ruled that the FDA must adopt new guidance, with proposed deadlines that “can be set sufficiently soon beyond the end of the notice and comment period to afford relief to plaintiffs and to attempt to combat the epidemic-level use of new tobacco products like e-cigarettes, especially by teenagers.”

In 2009, Congress enacted theFamily Smoking Prevention and Tobacco Control Act, which requires manufacturers of tobacco products, including e-cigarettes,to seek premarket authorization and approval before introducing new products.

In 2016, after notice and comment, the FDA exercised its authority to deem e-cigarettes, cigars and pipe tobacco as tobacco products subject to regulatory controls under the Tobacco Control Act. Known as the “deeming rule,” the FDA’s regulation went into effect Aug. 8, 2016.

“After the change in presidential administration, the FDA deferred for 90 days certain statutory and regulatory deadlines established by the deeming rule and the Tobacco Control Act,” the plaintiffs said in court documents. “The purpose of this delay, ostensibly, was for the new administration to reconsider its approach to the deeming rule. Then, in August 2017, without inviting public or stakeholder comment as required by the Administrative Procedure Act (APA) or building a new administrative record to guide its decision, the FDA issued what it labeled a ‘guidance’ that fundamentally altered the statutory duties and responsibilities of manufacturers of newly deemed tobacco products.”

According to the plaintiffs, the FDA’s guidance is “unlawful” because it exceeds the agency’s statutory authority and abdicates its responsibilities under the Tobacco Control Act by extending product application deadlines, some until 2021 and 2022, and by allowing manufacturers of those products to continue to market and distribute the products while they seek FDA approval. It is also unlawful, plaintiffs said, because it did not follow the APA’s notice and comment requirements and does not explain changes in direction as required under the APA.

“In issuing the guidance, the FDA flagrantly breached that obligation,” the plaintiffs said. “It offered no meaningful justification for ripping a hole in the statutory framework by exempting, for more than half a decade, newly deemed products from premarket review—review the FDA previously described as ‘central’ to the regulatory scheme Congress enacted for tobacco products.”

“Manufacturers long have been on notice that they will have to file premarket approval applications, substantial equivalence reports and exemption requests, and if they have chosen to delay their preparations to do so, then any hardship occasioned by their now having to  comply is of their own making,” Grimm said in his ruling. 

The plaintiffs and the FDA have about a month to respond to the court regarding a remedy.

“The FDA is reviewing the decision,” FDA spokesperson Michael Felberbaum said in a statement provided to CSP Daily News. “As [U.S. Department of Health and Human Services] and FDA leadership have reiterated, the agency has and will continue to tackle the troubling epidemic of e-cigarette use among kids. This includes preventing youth access to, and appeal of, flavored tobacco products like e-cigarettes and cigars, taking action against manufacturers and retailers who illegally market or sell these products to minors, and educating youth about the dangers of e-cigarettes and other tobacco products.”

“The courts are clearly pushing the FDA—at behest of medical and consumer groups—to step up their regulatory pressure” on the tobacco industry, Marc Scheineson, a former FDA official who now advises companies with the law firm Alston & Bird, told the Associated Press.

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