Public health groups sue FDA

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Public health groups are suing the Food and Drug Administration (FDA) for allowing candy flavored cigars, electronic cigarettes and other products to remain on the market for years without being reviewed and approved by the FDA.

The costly reviews of these products were required under new rules finalized by the outgoing Obama administration in May 2016 that for the first time gave the FDA authority to regulate cigars and e-cigarettes under the 2009 Family Smoking Prevention and Tobacco Control Act. 


The Trump administration, however, issued guidance to delay the reviews, in which FDA decides whether a product can legally be sold, and allow a product already on the market to continue to be sold once a years-long review is underway.

The Campaign for Tobacco-Free Kids and other groups behind the lawsuit argue candy flavored cigars and e-cigarettes appeal to children, who could grow addicted while the products are sold and before the reviews are completed.

“As a result of the guidance, consumers will continue to be exposed for many years to thousands of tobacco products containing lethal and addictive components that have not met the statutory requirements,” the groups said in their 45-page complaint, filed in the U.S. District Court for the District of Maryland.

The lawsuit says the FDA and the Department of Health and Human Services (HHS) exceeded their authority by delaying the reviews. 

“FDA has no legal authority to absolve regulated entities of their legal obligation to comply with statutory mandates in that manner.”

The groups also argue the FDA exceeded its authority under the Family Smoking Prevention and Tobacco Control Act and violated the Administrative Procedure Act by not giving the public an opportunity to comment on the deadline delays. 

The FDA issued guidance in July giving manufacturers of e-cigarettes and other electronic nicotine delivery systems until August 2022 to submit the pre-market applications for approval of products already on the market.  

Manufacturers of newly regulated combustible products, including cigars, pipe tobacco and hookah tobacco, were given until 2021.

The applications were originally due this year.

In addition to the Campaign for Tobacco-Free Kids, the lawsuit was brought by the American Academy of Pediatrics and its Maryland chapter, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association and Truth Initiative.

Tags Barack Obama Donald Trump FDA Food and Drug Administration Lawsuit Smoking Tobacco

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