FDA Lawsuit May Be Dead Before It Begins

The recent lawsuit filed by numerous national health groups is under fire from a well known legal expert with ties to the Food and Drug Administration. The suit was brought by health groups such as the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and the Truth Initiative. All very powerful and well known voices within the public health realm.

The groups’ lawsuit came in the wake of an FDA decision to delay the deadline for product applications until 2022. The application, known as PMTA or Pre-Market Tobacco Authority, is considered by the vapor industry to be the most expensive and burdensome regulation. PMTA applications require a manufacturer to pay an estimated 300 thousand dollars; and an application would need to be submitted for each SKU of a product. (For reference, if an eliquid manufacturer has one flavor with four nicotine strengths, it would cost an est. 1.2 million dollars.)

Their complaint alleges, among other things, that, “FDA has no power to act unless and until Congress confers that power.” Further:

“Agencies may not modify unambiguous requirements imposed by a federal statute. The Guidance does not simply fail to enforce statutory requirements; it purports to alter those requirements and to establish, with the force of law, that otherwise prohibited conduct does not violate the Tobacco Control Act.”

But Marc Scheineson questions the validity of the health groups' challenge. Scheineson is currently head of the food and drug practice at Alston & Bird and former associate commissioner for legislative affairs at the FDA. He questions the very standing these groups have to file a lawsuit in the first place.

“In order to have a case accepted procedurally, you have to be in a class that was intended to be protected or regulated by the rule … the [deeming] rule is designed to regulate industry so a company that would be required to be compliant with the provisions is really the category that would have the most obvious standing. Public health groups like this really are not impacted one way or another by the rule because they don’t make the products … it would be a step removed.”

Congress has been implored to take action on the matter. Dr. Scott Gottlieb, current FDA commissioner, pulled back on the previous deadline for PMTA applications. He stated the agency needed additional time to do more research into the potential for harm reduction vapor products provide. In the meantime, other regulations, such as prohibiting sales to minors, Child-safe caps, ingredient lists and labeling guidelines are proceeding as planned.