The FDA is being sued by several large e-juice manufacturers including Turning Point Brands, a company that reportedly spent in the millions of dollars on their PMTA applications to the FDA. The Turning Point Brands lawsuit has been filed in the Sixth Circuit Federal Court of Appeals.
The company is suing on the grounds that the FDA's issuance of a Marketing Denial Order (MDO) is "arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.”
The argument hinges on the fact that the FDA has claimed, in all the 323 MDO's it has issued covering nearly every vape manufacturing company in the United States, that the denials are based on a lack of “sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.”
The problem is, this standard was in no way made clear prior to the due date for manufacturers to submit PMTA applications in September of last year. Applying this standard retroactively in order to reject applications certainly seems "arbitrary and capricious."
Meanwhile, the FDA has said that products remaining on the market after receiving MDOs are among the agency’s highest enforcement priorities--not the black market, not Juul which is still the product of choice for 25% of underage vapers--the small vape companies that have poured their life savings into their PMTA applications, only to have the FDA turn around and dismiss them all based on an excuse they came up with after the fact.
While Kai's Virgin Vapor has received an MDO, the FDA has not yet issued us a list of the actual products the MDO applies to so we are continuing to make our e-juices available to our customers.
Kai's Virgin Vapor is also continuing to pursue all possible avenues to try to find a way to continue to serve our customer base which depends on us to keep from returning to smoking cigarettes.
We have received numerous impassioned and desperate letters from our customers expressing their outrage and fear that the FDA is taking away their right to use flavored vaping products.
We hear your voices and we are doing everything that is humanly possible to try to find a way to continue to be here for you.