National and state trade associations representing the e-cigarette industry filed suit against the U.S. Food and Drug Administration (FDA) over new regulations that the advocates contend will push innovative products out of the market.
The plaintiffs in the suit, filed by Keller & Heckman, include the Right to be Smoke-Free Coalition, American E-Liquid Manufacturing Standards Association, American Vaping Association and the Electronic Vaping Coalition of America, among others.
The challengers claim the FDA’s new rule “sets forth obligations that reach far beyond any reasonable level of regulatory oversight and imposes requirements that are unlawful in their nature and scope.”
Regulators consider vapor products a “tobacco product” under the Tobacco Control Act. The FDA contends the regulatory framework will “prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks.”
The “tobacco” designation doesn’t fly with e-cigarette manufacturers and distributors.
“The agency adopted a ‘one-size-fits-all’ approach even though Congress was clear in the [Tobacco Control Act] that the agency should use its regulatory authority in a flexible manner that recognizes the continuum of risk presented by different tobacco products,” the complaint, filed in Washington federal district court, said. “This is evidenced by the fact that FDA was directed to ensure that adults continue to have access to tobacco products, particularly newer, more innovative products that present less health risk than traditional ones.”
The complaint alleges the FDA’s regulatory scheme “will all but guarantee, in a direct challenge to Congress’ wishes, that the vast majority of such products will be forced to exit the market over the next two years.”
A spokesman for the FDA, citing the pending case, declined to comment. In May, when the FDA rolled out the new rule, Sylvia Burwell, the Health and Human Services Department secretary, said the rise of e-cigarettes “is creating a new generation of Americans who are at risk of addiction.” Burwell said the e-cigarette regulations would “help us catch up with changes in the marketplace.”
The challenge to the regulations is at least the second filed recently in Washington, DC. In May, Covington & Burling filed suit for Nicopure Labs. That complaint called the scope of the FDA’s e-cigarette regulations “staggering.”