America’s e-cigarette market is currently the largest in the world, according to Euromonitor International. In 2015, vaping products reached $8 billion worldwide, driven by an estimated 30 million users. That was an 8% increase in sales over 2014, and much of the growth happened in North America. Last year, 43% of e-cigarette products were sold in the US, around three times the amount purchased in the UK, currently the world’s second-largest vaping market.
E-Cig Regulations “Unlawful,” Vaping Groups Say
Growth is expected to slow further now that e-cigarettes are being regulated by the Food & Drug Administration. The agency’s decision, which will require every e-cig manufacturer to apply for safety and quality approval, is a major point of contention. Most vape companies claim prohibitive approval expenses will push smaller manufacturers into bankruptcy. Some vape proponents have gone further, calling the FDA’s ruling “illegal.”
In a lawsuit (PDF) filed on June 20, 2016, 11 vape-centered trade associations say the FDA’s new “deeming” rule, which places e-cigarettes under the same umbrella as cigarettes, “sets forth obligations that reach far beyond any reasonable level of regulatory oversight and imposes requirements that are unlawful in their nature and scope.”
To be clear, the e-cig groups don’t oppose all of the agency’s regulations. Preventing kids from using vaporizers, and providing the FDA with thorough health and safety data, are fine, they write. But calling e-cigarettes a “tobacco product,” and treating them just like combustible cigarettes, “fails to recognize the unique position [vaporizers] occupy in the marketplace.”
Is FDA Pushing E-Cigs Out Of The Market?
The FDA itself has acknowledged that electronic cigarettes “are potentially safer products that could lead to reduced smoking levels,” the groups claim. But requiring that the products go through an extensive pre-market authorization process, which no one doubts will be extremely costly, ensures “that the vast majority of such products will be forced to exit the market over the next two years,” they write.
Effectively, the FDA has decided to crush the growing e-cig industry, the associations argue, which isn’t just bad for business, but public health as well.
By the groups’ logic, pushing the vast majority of e-cigarette products out of the market is illegal, an express contradiction of Congress’ intentions in passing the Tobacco Control Act. Rather than banning tobacco products outright, the lawsuit argues, Congress wanted to strike a balance, between allowing adults “ready access” to the products and keeping them out of the hands of children.
Perhaps more crucially, “Congress instructed FDA to regulate tobacco products in a manner that promotes the introduction and sale of safer and less harmful tobacco products, rather than keeping them off the market,” according to Plaintiffs. That “safer and less harmful” product is now staring the FDA in the face, the associations write. But instead of emphasizing the relative benefits e-cigarettes may hold for smokers, they say the agency has simply chosen to limit their ultimate availability.
There is an alternative, however, the lawsuit says. In fact, the Tobacco Control Act makes it clear that alternatives should be used for different tobacco products. Plaintiffs say Congress gave the FDA “flexibility” in reaching its regulatory and enforcement goals. Instead of recognizing the unique risks and benefits posed by e-cigarettes, they write, the agency chose a “one-size-fits-all” approach.
The concept of a “continuum of risk” is crucial to their argument. Some products are more dangerous than others, despite being classified under the same category. It’s a spectrum, one that Plaintiffs say FDA failed to take into account in crafting its new regulatory authorities over the vape industry. In the words of Mitch Zeller, Director of the agency’s Center for Tobacco Products,
“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.”
E-cigarettes are a new step on this spectrum, Plaintiffs argue, one that should have been treated as such. The possibility that vaping could simply create a new pathway to nicotine addiction for non-smokers, however, is not specifically addressed in the complaint.
Multiple Lawsuits Question Legality Of Regulations
Whether or not these arguments will prevail in court is unknown. FDA officials declined to comment when pressed for response by the National Law Journal, but that’s standard practice in these situations.
The case is Right To Be Smoke-Free Coalition et al v. Food and Drug Administration et al. It was filed in the US District Court for the District of Columbia under case number 1:16-cv-01210-ABJ.
A similar suit was filed against the FDA, along with the agency’s commissioner and the Secretary of Health and Human Services, was filed in May by a Florida e-cigarette manufactured. Due to their similarities, the court has suggested consolidating the cases.