R Street encouraged by legal challenge to FDA deeming rules
WASHINGTON (May 12, 2016) – The R Street Institute is encouraged by news that Nicopure Labs LLC, a Tampa-based manufacturer of nicotine e-liquids and vaping devices, has filed federal suit challenging the Food and Drug Administration’s deeming rules for e-cigarettes.
The suit, filed in U.S. District Court for the District of Columbia, charges the FDA with violating the Administrative Procedure Act by promulgating rules in an arbitrary and capricious fashion and without a rational basis to protect public health; that the agency applied faulty benefit-cost analysis; and that the rules interpret the term “tobacco products” in ways that are plainly inconsistent with the Tobacco Control Act of 2009. The company also charges that the deeming rule violates its First Amendment rights.
The following statement can be attributed to Dr. Joel L. Nitzkin, R Street’s senior fellow in tobacco policy and former co-chair of the Tobacco Control Task Force of the American Association of Public Health Physicians:
As a physician who has dedicated his career to the protection of public health, I applaud Nicopure for challenging the recently announced deeming regulations for e-cigarettes and other tobacco-related products. As I see it, Nicopure is correct in each of their allegations.
Those within the public health community who have enthusiastically supported both the text of the FDA Tobacco Law and the deeming regulations – a group that includes leadership of the FDA and the Centers for Disease Control and Prevention; the Cancer, Heart and Lung Associations; Tobacco Free Kids; and so-called academic ‘experts’ – should take a close look at the allegations. The public health community must develop a set of amendments to the FDA Tobacco Law that bring both the law and regulations in line with policies that help, rather than damage, both the public health and the credibility of these major public health stakeholders.
A bitter fight and predictable loss in court could do considerable damage to our collective ability to provide health-related guidance to the public and to secure public participation in steps needed to protect us from Zika virus, contaminated water supplies and other public health emergencies.
