At the behest of a collective public health group lawsuit, a Federal Judge has issued an order to the FDA - the e-cigarette review process needs to happen sooner. The decision was handed down earlier today in the district courts, arguing that the FDA has neglected it's duty to effectively address the so called "epidemic" electronic cigarettes have seemingly perpetuated.
In 2016, the FDA gained regulatory authority of the electronic cigarette market after years of failed attempts. Outlined in this regulatory authority is a process called the PMTA, otherwise known as the Pre-Market Tobacco Authorization. For products not on the market prior to 08/08/16, a PMTA is required for the product to be legally sold in the United States. Originally slated for 2018, former FDA commissioner Scott Gottlieb moved the deadline up to 2022, than back down to 2021, upon his recent exit - providing much needed relief to the industry at large.
Wednesday's ruling aims to bring this process to a head, requiring the FDA to submit plans for product reviews within 30 days. Though it is too early to tell, concern is mounting - will the FDA require the PMTA process to go into effect sooner? The ramifications this poses against the market at large are concerning; the current PMTA outlines are vague at best, prohibitive in nature, and costly, rendering a majority of industry shareholders from seeking FDA approval at all.
The next 30 days will be very interesting in the electronic cigarette industry, as we all eagerly anticipate the FDA's response. Check back in with us for the latest news on electronic cigarettes, drop a comment and let us know what you think.