FDA sued by health groups for 'dilly-dallying' over rules for e-cigarettes

By Dr. Ananya Mandal, MDMar 28 2018

The Food and Drug Administration (FDA) has been sued by several major public health groups because of the delays on the agency’s part to implement rules regarding electronic cigarettes and cigars. The health advocates say that this delay could mean that more consumers could be exposed to “lethal and addictive components” of these tobacco products for years before they could be controlled.

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The latest lawsuit is out against the decision taken by the agency last year to grant extensions of deadlines to the manufacturers that were seeking FDA approval for their products. Earlier the companies were asked to submit product reviews by 2018 August for items that came into the market after 2007 February. The FDA then extended the deadlines to 2021 August for cigars and 2022 August for e-cigarettes with no justifications say the health groups.

The initial efforts and talks had suggested a ban on these products. This extension has allowed that e-cigarette industry to continue to market safely until the renewed deadlines. The health groups are furious about the fact that these additional years would mean that more teenagers and young adults are targeted with these flavoured tobacco products that are marketed as low-tobacco containing alternatives.

The health advocates that have sues FDA for this seemingly deliberate delay in implementing rules to protect the health of the youngsters include American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative. Children and teenagers are most at risk the agencies have stated and several stand-alone paediatricians have also joined these organizations in suing the FDA in federal court in Maryland. The FDA declined to comment on this at present.

According to Campaign for Tobacco-Free Kids President Matthew Myers, this delay is leaving kids vulnerable while the FDA waits for e-cigarette manufacturers to apply with necessary reports. This would be the second time that the Campaign for Tobacco-Free Kids has sued the FDA, the last one being in 2016 when they sued the agency to insist manufacturers to put up graphic health warnings on cigarette packaging.

FDA last summer under the guidance of FDA Commissioner Scott Gottlieb had announced a major overhaul of the tobacco and nicotine containing products that would go on to save millions from tobacco related diseases. Recently the FDA also called for a public comment on reducing the nicotine content of conventional cigarettes to non-addictive or minimal-addictive levels. This plan is also supported by the health groups that sued the FDA yesterday (27th of March 2018).

Gottleib has called tobacco usage as a “continuum of risk” and has reiterated that e cigarettes could be less harmful and may help smokers to quit regular smoking. “We need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels…And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them,” he had said.