Tobacco companies will need to submit product review applications to the FDA for review by the Sept. 9 deadline
On May 4, the U.S. Court of Appeals for the Fourth Circuit dismissed an appeal from tobacco industry allies that would have further delayed the implementation of federal guidance that will require e-cigarette and cigar manufacturers to submit product applications to the U.S. Food and Drug Administration (FDA) for public health review.
The court held that the e-cigarette appellants would need to file a new lawsuit altogether if they hope to challenge the 2020 FDA guidance requiring product review; it also ruled the cigar manufacturers’ attempts to intervene in the case came too late for them to be a party.
In March 2018, ACS and ACS CAN joined other public health and medical organizations as plaintiffs in filing a lawsuit that argued the FDA unlawfully delayed its mandated review of certain tobacco products, primarily e-cigarettes.
Last yea,r U.S. District Judge Paul Grimm ruled in favor of the plaintiff groups, finding that the FDA had exceeded its legal authority in delaying its review requirement. Judge Grimm initially set a May 12, 2020 deadline for tobacco manufacturers to file product applications with the FDA, but recently issued a three-month deadline extension at the request of FDA and industry due to the ongoing COVID-19 pandemic. Today’s ruling by the appellate court denied e-cigarette manufacturers’ attempt to further delay product review.
The appellate ruling against the tobacco industry’s maneuvering means tobacco companies will need to submit product review applications to the FDA for review by the September 9, 2020 deadline.
The following is a statement from ACS CAN President Lisa Lacasse:
“We know the tobacco industry and their allies will use any opportunity to avoid oversight of their addictive and deadly products. Tobacco and e-cigarette manufacturers have had plenty of notice to comply with submitting legally required product review applications to the FDA and regulation is long overdue after so many years of unfettered access to peddle addictive products to a generation that should have and could have been tobacco-free. We applaud the Fourth Circuit Court of Appeals for its dismissal of this shameless attempt by the tobacco industry to once again skirt regulatory oversight at the expense of the public health.”