Notice of Appeal Filed in Deeming Rule Challenge by Right to be Smoke-Free Coalition and Nicopure Labs
On August 30, 2017, the Right to be Smoke-Free (RSF) Coalition, a non-profit, industry-led trade association of vapor businesses dedicated to advocating for reasonable and responsible laws and regulations, joined Nicopure Labs LLC in appealing the recent decision in Nicopure Labs, LLC and Right to be Smoke-Free Coalition et al. v. Food and Drug Administration et al., Civ. No. 1:16-cv-0878-ABJ to the U.S. Court of Appeals for the District of Columbia. The lawsuit challenges aspects of FDA's Deeming Regulation and the Tobacco Control Act as they are being applied to the vapor industry. The RSF Coalition respectfully disagrees with the conclusions reached by the lower court and believes that both the law and the facts compel a different result.
While FDA's recent announcement acknowledging the tobacco harm reduction potential of vapor products and extending the compliance policy deadline for Premarket Tobacco Product Applications (PMTAs) for pre-August 8, 2016 vapor products to August 8, 2022 is welcome news, the RSF Coalition believes that there remains much worth fighting for on behalf of the industry - which still faces effectively being banned in a few short years.
"There is no greater risk to public health than traditional combustible tobacco use-related morbidity and mortality", said Scott Eley, RSF Coalition Director and Co-Founder of coalition member, NicQuid. "We believe vapor products can help make tobacco-related death and disease part of America's past and not it's future. While we fully support all efforts to prevent access to vapor products to kids, we would hate to see a future where FDA's overly burdensome regulatory approach prohibits access to these products by adult smokers looking for an alternative to their tobacco addiction."
Since the Deeming Rule took effect on August 8, 2016, the restrictions on vapor products have been even more onerous than combustible cigarettes, most of which are grandfathered and exempt from FDA's premarket review requirements. Among other things, vapor companies today cannot legally introduce new products, or improve the safety and quality of their existing products, without FDA PMTA authorization; distribute free samples to adults; or make truthful statements about the relative safety of their products.
The RSF Coalition and Nicopure Labs are being represented in the appeal by Keller and Heckman LLP Partners Eric Gotting and Azim Chowdhury. For more information on the lawsuit and to contribute to the RSF Coalition appeal efforts, visit www.r2bsmokefree.org.