AMA Supports Lawsuit Against FDA Over E-Cig Rules Delay

The American Medical Association (AMA) is amongst a number of organizations which support a lawsuit that the American Academy of Pediatrics (AAP) and others had filed against the FDA, for a delay in regulating e-cigarettes.

Diane Caruana

October 15, 2018

The lawsuit against the FDA was filed in the U.S. District Court for the District of Maryland earlier this year. “It is illegal, unreasonable and devastating for the public health for the FDA to postpone its oversight obligations any further,” said the AMA and others in an amicus brief. Every day the FDA delays these regulations, these tobacco products which are aimed at addicting new users, are putting the public at risk, inaccurately added the organizations.

The FDA’s deeming rule had rocked the vaping industry and led to the demise of several small well meaning vaping businesses. Many of these ventures were set up by ex-smokers who managed to quit with the help of e-cigarettes and were therefore motivated to share the products that helped them quit with the rest of the world.

PMTA submission deadline delayed to 2022

Then in August 2017, the FDA announced a major shakeup to the agency’s policy on e-cigarettes which included the de-nicotinization of cigarettes, and a PMTA deadline delay. Following that announcement, the FDA had issued a guidance titled Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule, in order to formalize and explain this deadline extension.

Contrary to what these health organisations are claiming, in countries where e-cigs have been fully endorsed, smoking rates keep dropping at a significant rate.

However, this led to the agency being sued over claims that the delay will lead to consumers will be exposed to “lethal and addictive components” in tobacco products. Amongst the organizations filing the lawsuit in the federal court in Maryland, there are the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative.

“It is neither lawful nor reasonable for the FDA to abdicate its statutory obligations for so many years,” the AMA and others told the court in its amicus brief, in support of the AAP’s case. “The public health consequences alone explain why.”

Positive results when e-cigs are endorsed as harm reduction tools

In the meantime, while the aforementioned so called health experts are busy demonizing vaping, earlier this year Public Health England (PHE), released findings from an e-cigarette review conducted by leading independent tobacco experts, which updated the organization’s 2015 vaping report, confirming that vaping is at least 95% safer than smoking.

The PHE is renowned for being actively involved in campaigning for the use of e-cigarettes as smoking cessation tools. In fact following the release of a 2015 report, the organization had even issued guidelines for employers urging them to support vapers at their workplaces. As a result of this stance, the UK is reporting the lowest number of smokers ever recorded and the second lowest smoking rates in Europe.

Read Further: AMA