The decision by the U.S. Food and Drug Administration (FDA) to reject the application of Logic Technology Development’s electronic nicotine delivery system (ENDS) has been upheld in the Third Circuit Court of Appeals. The decision, which was filed October 19, supports the FDA’s authority to regulate new and emerging ENDS technology, particularly with regard to flavored e-cigarette products.

The FDA has had a storied past with ENDS products. Initially a booming market, the FDA later imposed a number of actions against ENDS manufacturers that impeded growth and sales. The most notable enforcement action was the requirement for all ENDS manufacturers or importers to submit a marketing approval application to allow their products to be sold in the United States. 

While these applications were being filed, the FDA took a number of strong steps towards banning e-cigarette products that used fruit and dessert flavors. The agency’s rationale was that these flavored products posed an undue risk to underage consumers as the data shows that sweet or fruity flavored e-cigarette products are highly appealing to minors and could result in increased rates of underage tobacco use.

At the time that they were denying the applications of ENDS flavored products, they set aside the issue of whether menthol or mint flavored ENDS products would be similarly banned. However, the FDA stated that after considering the studies and evidence it was in the public’s best interest to ban menthol products as well.

The plaintiff in the case in question, Logic Technology Development, argued to the Third Circuit of Appeals that the FDA was making “arbitrary and capricious” decisions to apply the same standard of scrutiny it applied to “sweeter flavors” to menthol flavors. Additionally, Logic Technology Development argued that they were owed a transitionary period to implement these “unreasonable” changes and cannot be expected to just immediately stop manufacturing, distributing, or selling menthol products. ‘

In the majority decision, Judge Cheryl Ann Krause wrote that the panel found the arguments of Logic “unpersuasive.” The court held that the FDA applied a regulatory framework consistent with its statutory mandate and the agency’s actions are fully covered by the Tobacco Control Act which requires manufacturers to receive approval from the FDA for all tobacco products that have come onto the market since February 15, 2007.

If you or a loved one have been injured after using ENDS, consumer products, drugs, or medical devices, you may be entitled to financial compensation. Contact Medtruth today for a free case review and begin your journey to justice.