Historical lawsuit slams FDA e-cig regulations with 8 violations
On June 20, 2016, eleven advocacy groups for users of electronic cigarettes and vaping devices united to file a single lawsuit over the recently announced FDA e-cig regulations. The case was filed in the District Court of Washington, D.C. and lists eight possible points of contention that the plaintiffs believe are either unconstitutional or downright illegal. While this is not the first lawsuit of its kind, it appears to be one of the most promising, according to many industry insiders.
Issue #1: The Predicate Date
The lawsuit questions the legality of the February 15, 2007 predicate date for the Pre-Market Tobacco Applications process (PMTA). By back-dating this predicate date, nearly 100% of the entire vaping industry’s products would fall victim to the million-dollar and time-consuming approval process within the next two years. The lawsuit suggests moving the predicate date forward to the date that the FDA e-cig regulations take effect.
Issue #2: The PMTA Process
Under the U.S. Administrative Procedures Act, the PMTA process is reserved to only “tobacco products.” Since vaping devices and e-cigs are 100% tobacco-free, the lawsuit claims that the FDA does not have the legal authority to require manufacturers of the vaping industry to adhere to a federal approval process that is typically only reserved for Big Tobacco. With an estimated price tag of $1 million per product, the PMTA process will essentially wipe out the entire industry. The plaintiffs propose an alternative – the submission of a Substantial Equivalence (SE) Report.
(Related Article: NEW FDA E-CIG REGULATIONS AND THE MILLION-DOLLAR PMTA PROCESS)
Issue #3: Unconstitutional
The U.S. Tobacco Control Act, of which the FDA regulations are partially based, makes it very clear that different products present different health risks. But the legislation does not provide clear instructions for how to regulate new products that center the marketplace that are significantly safer than traditional tobacco products, like e-cigs, for example. Therefore, the entire U.S. Tobacco Control Act is unconstitutional, and the FDA e-cig regulations should be nullified.
Issue #4: Ban on Free Samples
A ban on free samples essentially violates the U.S. Administrative Procedures Act and the First Amendment of the U.S. Constitution, which states, “Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the government for a redress of grievances.”
Issue #5: Smoke vs. Vapor
Under the U.S. Administrative Procedures Act, there is a special provision called The Modified Risk Tobacco Product (MRTP) which discusses the different levels of health risks associated with tobacco products. This provision seems to focus largely on the harmful substances found in tobacco smoke. But vaping devices and e-cigs do not contain tobacco and do not produce “smoke.” Therefore, the U.S. Administrative Procedures Act, does not apply to the vaping industry, and the new FDA e-cig regulations should be nullified.
(Related Article: NICOPURE MAKES HISTORY; FILES FIRST LAWSUIT OVER FDA E-CIG REGULATIONS)
Issue #6: “Tobacco Product” Classification
By following the chain of issues outlined so far, the plaintiffs take the time to clearly point out with laser-like focus that e-cigs and vaping devices are 100% tobacco-free. Based on this single point of contention alone, the plaintiffs claim that the FDA e-cig regulations do not apply.
Issue #7: Impacts to Small Business
Under the U.S. Regulatory Flexibility Act, all federal agencies must take into consideration the possible effects that their regulatory actions have on small businesses. The predicate date comes into play again, because nearly 100% of today’s e-cigs and vaping devices were placed on the market after the predicate date of February 15, 2007. As a result, all retailers would be required to obtain FDA approval through the PMTA process, which most business owners cannot afford. This is also one of the main issues that Sen. Ron Johnson is questioning by sending those letters to the FDA in the recent past.
Issue #8: Wiping out the E-cig and Vaping Industry
According to the U.S. Tobacco Control Act, the FDA is required to consider the costs and benefits of their legislative actions. And under the U.S. Regulatory Flexibility Act, the FDA failed to consider other regulatory alternatives to the PMTA process that would be less costly and perhaps less time-consuming for small business owners. The lawsuit alleges that the FDA essentially went for a one-size-fits-all solution, grabbing the already written regulations for Big Tobacco, and slapping them onto the vaping industry without a second thought.
Of course, the legal language used in the court documents filed for the eleven plaintiffs is much more elaborate than the above breakdown of eight different points. But for members of the vaping community who are only now hearing about the potentially devastating FDA e-cig regulations, this latest lawsuit seems to hit nearly every major argument that threatens the very existence of the vaping industry.
Vape shop owners love what they do, and they also want to keep selling their products and e-liquids to millions of happy customers. However, if the FDA e-cig regulations are not overturned, consumers may see thousands of their favorite e-juice flavors, vape mods, and even wicks and batteries disappear almost overnight. These eleven advocacy groups are fighting for the rights of all vapers and e-cig users in America.
Special Edit from Matt: I corrected a slight error in the wording of point #7 based on readers' comments. Thanks so much for pointing this out. The last thing that we want to do is confuse the vaping community even further. Fighting the FDA Deeming Regulations is a very important issue that needs everyone's support. I apologize for the error. And thanks again!