FDA Sued For Delaying Tobacco Regulation

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FDA Sued For Delaying Tobacco Regulation

Seven different public health groups and pediatricians are suing the U.S. Food and Drug Administration (FDA) for delaying the regulation of tobacco products and the guidance on the product being confusing and not entirely clear.

The FDA began regulating cigars, vapor, e-cigarettes and hookah in 2016 with the announcement of its deeming rules. While some compliance deadlines were delayed last year but the regulations have remained in place regardless. Recently, the FDA has issued several advanced notice of proposed rulemaking (ANPRM) related to its regulation of tobacco products including one on nicotine, flavored tobacco, and premium cigars.

Now, public health groups–including the American Academy of Pediatrics, American Academy of Pediatrics (Maryland), American Cancer Society Cancer Auction Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and the Truth Initiative along with several pediatricians–have an issue with the delay and extensions in enforcing different parts of the deeming rules, and have decided to sue the FDA because of it.

The lawsuit was filed in a Maryland courtroom on March 27, 2018 calls into question the the FDA’s guidance and how its handling of tobacco regulation so far has been “arbitrary and capricious and not the product of reasoned decision making.” The lawsuit also accuses the the FDA of neglecting its responsibilities as defined by the Tobacco Control Act and that the FDA failed to seek public input before implementing its deeming rule.

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