The Right to be Smoke-Free Coalition, representing 11 e-cigarette advocacy groups and trade associations recently filed a lawsuit against the Food and Drug Administration, in an effort to have its new e-cigarette regulations declared unlawful and unconstitutional.
In the lawsuit filed on June 20th, 2016, the plaintiffs claim that the FDA’s final ruling on e-cigs “sets forth obligations that reach far beyond any reasonable level of regulatory oversight and imposes requirements that are unlawful in their nature and scope.” Their argumentation tackles a variety of issues, from the agency’s one-size-fits-all strategy of regulating all tobacco products virtually the same to the expensive PMTA approval process and the contested predicate date set by the Tobacco Control Act.
The vaping associations say that the Tobacco Control Act of 2009, on which the FDA regulations are based on, makes it very clear that different products present different health risks, thus less dangerous e-cigs should not be subjected to the same draconian rules as tobacco analogs. They note that the Food and Drug Administration has already acknowledged that e-cigarettes “are potentially safer products that could lead to reduced smoking levels,” and yet it did everything in its power to take them off the market.
The lawsuit also quotes Mitch Zeller, Director of the agency’s Center for Tobacco Products, as saying “anyone who would ponder the endgame must acknowledge that the continuum of risk exists and pursue strategies that are designed to drive consumers from the most deadly and dangerous to the least harmful forms of nicotine delivery.” But instead of recognizing the unique risks and benefits posed by electronic cigarettes, the FDA simply opted for a one-size-fits-all solution that is bad for both business and public health.
But plaintiffs say there is a solution to this problem. The Tobacco Control Act makes it clear that alternatives should be used for tobacco products and Congress gave the FDA “flexibility” in reaching its regulatory goals, so the agency’s regulations should be nullified and redone to reflect the difference in risk between electronic cigarettes and tobacco analogs.
According to FDA regulations, all vaping products released after the predicate date of February 15, 2007 would have to be subject to an extensive PMTA evaluation that could take years and cost over $1 million per product, in order to remain on the market. Otherwise, they would have to be taken off the market within the next two years. Plaintiffs suggest changing the predicate date to August 8th, 2016, the day the new regulations come into effect. That is what the Cole-Bishop amendment proposes as well, and while it would mean no new products could be launched after that date without going through the PMTA process, it would also allow us to keep using modern devices instead of outdated cigalikes from 9 years ago.
The Right to be Smoke-Free Coalition claims the Pre-Market Tobacco Applications process (PMTA) is reserved to only “tobacco products,” and since electronic cigarettes are 100% tobacco-free, the FDA has lo legal basis for subjecting them to the same requirements. The high costs and lengthy proceedings of the PMTA are expected to wipe out 99% of e-cigarette businesses, including manufacturers, distributors and sellers. The coalition proposes the submission of a Substantial Equivalence (SE) Report as an alternative. However, such a solution would only work if the predicate date is changed to August 8th, 2016, because otherwise, company could only introduce products that are substantially equivalent to rudimentary e-cigs from 2007.
Regarding the impact these new e-cigarette regulations will have on businesses, plaintiffs claim that under the U.S. Regulatory Flexibility Act federal agencies must consider the costs and benefits their rulings will have on small businesses. In this case, the PMTA requirements alone are expected to virtually 99% of small businesses in the e-cigarette industry. Thus, the FDA’s regulatory actions are unlawful.
The lawsuit clarifies that the plaintiffs do not oppose all e-cigarette regulations proposed by the Food and Drug Administration. Sale restrictions to minors as well as safety and quality control measures for vaping products, for example, are welcomed by the industry. However treating electronic cigarettes as tobacco cigarettes and essentially banning them, are not.
The Right To Be Smoke-Free Coalition et al v. Food and Drug Administration et al case is the second one of its kind in a span of two months. Previously we reported on the lawsuit filed by Nicopure Labs against the FDA.