U.S. District court judge Paul Grimm has caused apprehension in the vaping industry by invalidating the FDA’s extension of Premarket Tobacco Application (PMTA). The reason this delay existed in the first place was due to the sheer difficulty involved in trying to regulate such a complex and diverse industry.
The FDA has always felt that it was still not possible to rationally enforce the laws once they were created.
Due to public pressure from health groups, Judge Grimm has asked the FDA to present plans for product reviews within the next 30 days. No vaping company has issued a PMTA application because of the sheer cost (amounting to $1 million) as well as the legal uncertainty that currently exists.
Luckily, it is believed that there will be strong petitions for injunctive relief which could resolve the situation in a more rational manner.