In May through July several groups have filed lawsuits against the US Food and Drug Administration alleging that the deeming regulations that expand the regulation by FDA of additional tobacco products violate the law.
Currently there are eight lawsuits pending, of which 5 pertain to the vapor industry. Two of these five have been consolidated because they address similar claims.
Nicopure Labs LLC was the first to file and its case will be consolidated with one filed by eleven vapor trade associations. It asks the court to set aside the unlawful deeming regulations. The FDA estimates that pre-market review will cost $300,000 per product. In this event, Nicopure Labs alleges that the company, which has 2400 stock keeping units, would have to pay $720,000,000, using FDA's own estimate per product, to process PMTAs to get its products approved by FDA. However, Nicopure believes the actual cost will be closer to $2-3M per stock keeping unit. Either way, the cost of complying with the deeming regulations, concludes Nicopure, effectively eliminates the company's ability to comply.
Three vape shops filed a law suit, seeking a jury trial, claiming the requirements of the deeming regulations on the vaping industry will effectively eliminate the entire industry. Another lawsuit was filed by a West Virginia Legislator who claims he was able to quit smoking using vapor products, but that he will likely not be able to use them if they are eliminated by these regulations, and thus will have no choice but to return to use of tobacco products.
These cases raise an array of legal issues for the vapor industry including that FDA has: (i) improperly regulated vapor products which do not contain tobacco; (ii) failed to consider the effect of deeming regulations on small businesses as required by law; (iii) not quantified costs on small businesses, nor considered any alternatives; (iv) overstated benefits, and understated costs of complying.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
