FDA Sued for Delaying PMTA Compliance Deadline

In the last ten years, electronic cigarettes have exploded from non-existence to a $3.5 billion industry. An industry which up to less than a year ago, the FDA seemed set on destroying.

The infamous deeming rule has rocked the vaping world 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.

Then last August, the FDA announced a major shakeup to the agency’s policy on e-cigarettes which includes 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.

“The further extension of premarket review compliance deadlines covered by this guidance applies to all categories of newly regulated products that were on the market on August 8, 2016, including ENDS (e.g. e-cigarettes and e-cigars), hookah, pipe tobacco, and cigars. The compliance dates are being extended from November 8, 2017 (SE EX requests), May 8, 2018 (SE reports), and November 8, 2018 (PMTAs) to August 8, 2021 (SE EX requests, SE reports, and PMTAs for newly regulated combustible tobacco products, such as most cigars, pipe tobacco and hookah tobacco) and August 8, 2022 (SE EX requests, SE reports, and PMTAs for newly regulated noncombustible tobacco products, such as most ENDS or ecigarettes).” read the guidance.

Lawsuit from organizations who seem to keep missing the point

Many public health and harm reduction advocates were finally able to breathe a sigh of relief, as the FDA delayed the much disputed PreMarket Tobacco Applications (PMTA) until 2022. However, the agency is now being pressured from another end, as the suing parties claim that as a result of the PMTA delay, consumers will be exposed to “lethal and addictive components” in tobacco products.

Not surprisingly, 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.

These organizations have all been responsible for sharing misinformation about vaping in these last years, misinformation that could be costing a number of smokers their lives, as scientific research keeps indicating that switching from smoking to vaping could indeed spare them from a number of smoking-related diseases.

The premise of the lawsuit is that in delaying product reviews of e-cigarettes and cigars, the FDA is exceeding its authority under the 2009 tobacco-control act and violating the Administrative Procedures Act, as it did not give the public an opportunity to comment. The FDA has so far declined to comment on the legal action.

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, only last month Public Health England (PHE), released findings from an e-cigarette review that was conducted by leading independent tobacco experts, and 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: The Washington Post