The Food and Drug Administration is facing its largest lawsuit to date challenging its controversial tobacco deeming regulations that are scheduled to go into effect Aug. 8 for electronic cigarettes and vaporizers.
The Right to be Smoke-Free Coalition, representing 10 advocacy and trade associations, filed suit Monday in U.S. District Court for the District of Columbia.
Coalition members want a federal judge to permanently enjoin the FDA from implementing regulations that the FDA unveiled May 5. They want the regulations declared unlawful on constitutional and administrative grounds.
The typical e-cig is a battery-powered device that heats a liquid nicotine solution in a disposable cartridge and creates a vapor that is inhaled. A vaporizer can be supplied and reused through the insertion of a liquid capsule.
According to the coalition, about 20 million Americans have used an e-cig and/or vaporizer at least once.
As part of the federal Tobacco Control Act, FDA officials want new and enhanced products to be “substantially equivalent” to products already in the marketplace as of Feb. 15, 2007. The bulk of e-cigs and vaporizers debuted after that date.
The FDA defines substantially equivalent as “being the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health.”
Products introduced into the marketplace after that date would retroactively go through stiffer regulatory requirements to prove they don’t cause public harm. That includes providing more detail on liquid nicotine ingredients and manufacturing details.
Some industry observers say they believe the existing predicate date would drastically curtail product innovations, particularly by companies that don’t have the research and development budgets of Reynolds American Inc., Philip Morris USA and their affiliates.
The coalition said the regulations are a “direct challenge to Congress’ wishes” with the federal Tobacco Control Act. If allowed to go into effect, the coalition claimed “the vast majority of such products will be forced to exit the market over the next two years.”
“Plaintiffs are fully committed to the safety of electronic nicotine delivery systems, from manufacturing through distribution, and recognize the need for reasonable regulation at the federal level,” the coalition said in its lawsuit.
Analysts have said it could cost millions of dollars for each product to go through the heightened regulatory requirements. The FDA estimates it would cost about $500,000.
“FDA substantially overestimates the benefits of the deeming rule and underestimates its costs,” according to the complaint.
The FDA said manufacturers will be able to continue selling their products for up to two years while they submit a new tobacco product application. They would get an additional year during the review process.
House Republicans were successful in introducing an amendment to the fiscal 2016-17 federal agriculture budget that would allow the grandfathering of most current e-cigs and vaporizers if the FDA wants the funding needed to implement the new regulations.
Coalition members also object to their products being regulated as traditional cigarettes, which they described as a “one-size-fits-all” strategy, when there are an increasing number of studies that have shown a distinct harm-reduction role for e-cigs and vaporizers.
For example, the Royal College of Physicians issued a high-profile report in April that found e-cigs and vaporizers were 95 percent less harmful than traditional cigarettes.
Other tobacco products subject to potentially tighter regulations are cigars, pipe tobacco, nicotine gels, water-pipe or hookah tobacco and dissolvable products.
Nicopure Labs LLC of Tampa, Fla., was the first vaping company to sue the FDA over the regulations.
At least two cigar manufacturers have filed lawsuits. A subsidiary of Altria Group Inc., John Middleton Co. LLC, wants to stop the FDA from banning its “Black & Mild” brand name for cigars and pipe tobacco because mild is in the name.
Global Premium Cigars LLC of Miami wants to prevent the FDA from requiring labels that could comprise up to 30 percent of its cigar box. The group objects to how the FDA rules affect trademarked and copyrighted artwork.
