E-Cig Associations Suing FDA Over Deeming Rule
WASHINGTON, D.C. — The Right to Be Smoke-Free Coalition, American E-Liquid Manufacturing Standards Association, American Vaping Association and the Electronic Vaping Coalition of America are among several trade associations and state associations to file a lawsuit June 20 against the Food and Drug Administration (FDA) regarding its recently released final deeming rule.
The deeming rule extends the FDA’s authority to all tobacco products, allowing it to now regulate electronic cigarettes, cigars, hookah tobacco, pipe tobacco and more, in addition to cigarettes and smokeless tobacco, which have fallen under its authority since Congress passed the Family Smoking Prevention and Tobacco Control Act of 2009.
According to a report by The National Law Journal, the associations filing suit specifically took umbrage with the FDA classifying electronic cigarettes as tobacco products under the deeming rule, which was released May 5 and is slated to go into effect Aug. 8. The effective date is 90 days from the rule's publish date in the Federal Register.
The FDA “sets forth obligations that reach far beyond any reasonable level of regulatory oversight and imposes requirements that are unlawful in their nature and scope,” the complaint alleges.
The documents filed in Washington federal district court go on to say that "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. 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 deeming rule “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.”
As CSNews Online previously reported, the deeming rule requires manufacturers of all newly regulated products to show that the products meet the applicable public health standard set forth in the law and to receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The tobacco product review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as a product's appeal to youth and non-users, according to the FDA.
A spokesman for the FDA declined to comment on the associations' lawsuit when contacted by The National Law Journal.
However, on May 5, Department of Health and Human Services Secretary Sylvia Burwell said: "We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction. ... [The deeming rule] will help us catch up with changes in the marketplace, put into place rules that protect our kids, and give adults information they need to make informed decisions."
The plaintiffs in the lawsuit are being represented by Keller & Heckman.