Public Health Groups Sue FDA to Expedite Agency's Review of Tobacco Products
WASHINGTON, D.C. — The Food and Drug Administration's (FDA) decision to push back deadlines outlined in its deeming rule has come under fire.
On March 27, seven public health and medical groups, and several individual pediatricians filed suit in the U.S. District Court for the District of Maryland challenging the change in deadlines — which push back the agency's review of other tobacco products like electronic cigarettes and cigars.
The American Academy of Pediatrics and its Maryland chapter
The American Cancer Society Cancer Action Network
The American Heart Association
The American Lung Association
The Campaign for Tobacco-Free Kids
The Truth Initiative
Five individual pediatricians.
Campaign for Tobacco-Free Kids, the lawsuit contends that the FDA's decision leaves on the market tobacco products that appeal to kids, deprives the FDA and the public of critical information about the health impact of products already on the market and relieves manufacturers of the burden to produce scientific evidence that their products have a public health benefit.
The agency's review "should remove from the commercial marketplace those tobacco products that pose the greatest health risks, particularly those targeted at children and teenagers," according to the lawsuit.
In addition, the FDA's decision "will hinder the development of the science needed to understand, and to educate the public about, which products actually do promote smoking cessation and how they can be marketed without exposing young people to unnecessary risk."
The FDA released the long-awaited deeming rule in May 2016, and the regulations — with spelled out deadlines — included in it when it went into effect in August of that year. However, one year later the agency said it was delaying the provision requiring manufacturers to submit applications for products on the market as of Aug. 8, 2016, for agency review.
Under the revised timelines, applications for newly regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022, as CSNews Onlinepreviously reported.
The FDA changed the timeline as it unveiled a new roadmap for regulating the category, shifting the focus from tobacco to nicotine.
The move was "to make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes," it explained in July.
According to the release, the legal challenge contends that the FDA's delay of product review deadlines exceeds the agency's authority under the 2009 Family Smoking Prevention and Tobacco Control Act, which gave the agency the authority to regulate tobacco products.
The lawsuit also contends that the FDA's decision violates the Administrative Procedure Act because the agency did not give the public an opportunity to comment on the change and did not articulate an adequate factual basis for this radical change from the deadlines the FDA itself established in the deeming rule.
The FDA "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 — which the FDA previously described as 'central' to the regulatory scheme Congress enacted for tobacco products," the lawsuit states.
The public health groups are being represented on a pro bono basis by the law firm of WilmerHale, lawyers at the Democracy Forward Foundation and the legal staff of the Campaign for Tobacco-Free Kids.