Federal News Round-Up
Head of the Food and Drug Administration Scott Gottlieb announced a comprehensive regulatory plan for tobacco and nicotine on Friday. Gottlieb said the agency’s approach will place nicotine, and addiction, at the center of its regulatory efforts. The FDA’s full press release can be viewed here.
Gottlieb spoke extensively about the need for a comprehensive approach to nicotine, recognizing that though highly addictive the way nicotine is delivered represents a “continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.”
On combustible cigarettes, the FDA will establish a public dialogue about reducing nicotine to non-addictive levels through product standards.
Gottlieb said the FDA is committed to encouraging innovative reduced risk products that could benefit public health. To that end, the FDA will delay the application deadlines for e-cigarette products to August 8, 2022. The original deadline was August 8, 2018. The deadline for cigars, pipe tobacco, and hookah tobacco, will be extended to August 8, 2021.
The FDA will also seek input on how best to regulate flavored e-cigarettes and cigars that are alleged to appeal to kids. The FDA will also develop standards for vapor products to protect against “known public health risks.”
Gottlieb added that the agency will issue “foundational rules” to improve the product review process. This will include regulations outlining what information the agency expects to be included in Premarket Tobacco Applications and Modified Risk Tobacco Product applications. The FDA will also guidance on how it will review PMTAs for e-cigarettes.
In a 93-page decision, U.S. District Court Judge Amy Berman Jackson ruled in favor of the FDA’s exercise of jurisdiction in regulating e-cigarettes. The suit, brought by Nicopure Labs LLC and a coalition of vaping businesses and advocates, challenged the FDA’s authority and its exercising of that authority. Plaintiffs are currently considering whether to appeal to the appellate court. There are still a handful of remaining legal challenges to the FDA’s deeming rule outstanding.
A federal appeals court upheld an Obama administration regulation banning vaping on commercial flights. The lawsuit was filed by the Competitive Enterprise Institute (CEI) and Consumer Advocates for Smoke-Free Alternatives Association (CASAA). “It allows the commonly-understood language of Congress’s 30-year old non-smoking statute to be stretched into a ban on e-cigarettes — even though e-cigarettes involve no combustion and produce no smoke,” General Counsel for CEI Sam Kazman said of the decision.
State News Round-Up
Four state legislatures (and Guam, Puerto Rico and the U.S. Virgin Islands) are meeting actively this week.
California (local) flavor bans for vapor products continue to receive attention and the most recent legislation adopted in San Francisco has inspired a coalition to challenge the flavor bans via referendum. Reason’s Guy Bentley commented on California anti-vaping hysteria in the Orange County Register.
The Maine legislature overwhelmingly approved legislation that would change the age of purchase for tobacco products (including vapor products) to 21 but it was vetoed by Governor Paul LePage. A legislative override of the veto would require a 2/3 vote from both houses of the legislature. LePage argued 18-year olds who can be sent to fight for their country are “mature enough to make their own decision,” when it comes to tobacco use. Reason Foundation’s Brian Fojtik previously commented on the national effort after Texas rejected the proposal.
On July 25, the Joint Public Health Committee in Massachusetts heard legislation that would direct the Department of Public Health to conduct a comprehensive study evaluating and making recommendations regarding the use of harm reduction as a strategy for reducing smoking in Massachusetts and “thereby reducing death, disease and health care costs associated with the use of cigarettes.”
New Jersey Governor Chris Christie signed a law making New Jersey the third state to raise the age of purchase for tobacco products (including vapor products) to 21 years old. New Jersey, which already required tobacco purchasers to be at least 19, follows California and Hawaii. At least 28 New Jersey municipalities had already passed the age 21 law that Governor Christie vetoed previously.
Both houses of the Oregon legislature passed age 21 legislation for tobacco purchases (including vapor products) after removing penalties for possession by those under age 21. At the time this newsletter went to press, the legislation was still awaiting signature from Governor Kate Brown who previously indicated her support for the measure.
Science and Harm Reduction
Experts at the American Enterprise Institute criticized an article published in JAMA Pediatrics concerning the correlation between e-cigarette use and subsequent cigarette smoking among adolescents and young adults. “Empirically, it is certainly not clear that more vaping has any causal effect on smoking among youth, as Soneji and his co-authors imply but do not demonstrate,” write AEI’s Alex Brill, Sally Satel and Stan Veuger. “Moreover, the type of analyses reported in JAMA Pediatrics fails to offer a reliable basis for developing an optimal regulatory framework for e-cigarettes and other modified risk tobacco products.”
The United Kingdom’s Department of Health released its tobacco control plan for England. The plan commits to helping people quit smoking by “permitting innovative technologies that minimize the risk of harm.” Public Health England (PHE) also produced guidance for employers looking to introduce workplace policies with regard to vaping. PHE recommends that vaping should not be covered by smoke-free legislation and should not be routinely included in companies’ smoke-free policies.
Examining the plan, public health expert Clive Bates said it was the “first coherent statement of government level support for embedding low-risk alternatives to smoking and the concept of tobacco harm reduction in a major policy paper anywhere in the world.” Christopher Snowdon, Head of Lifestyle Economics at the Institute of Economic Affairs, welcomed the positive attitude toward innovative nicotine products but was critical of plans for further smoking bans and higher cigarette taxes.
Senior fellow and harm reduction policy director for the R Street Institute Carrie L. Wade argued in the Daily Caller that draconian regulation of reduced risk nicotine and tobacco products harms public health. “When lawmakers propose flavor bans or include e-cigarettes in the definition of ‘tobacco products,’ they are doing so out of concern for the risk of youth initiation to smoking. However, the reality is that the primary effect of limiting flavor options is that people who would use e-cigarettes to quit are left behind,” writes Wade.
A Pennsylvania federal judge rejected the state’s attempt to dismiss a challenge to its tax on e-cigarettes and non-vape-specific components. East Coast Vapor LLC argues the tax violates the state Revenue Department’s interpretation of the Tobacco Products Act and is breach of state law and the Constitution. The current law imposes a 40 percent tax on vaping wholesalers at the time e-cigarettes are first sold to retailers and also requires retailers to pay a 40 percent “floor tax” on unsold inventory.
What’s Coming Up?
A coalition seeking a referendum to challenge San Francisco’s vaping flavor (and menthol cigarette) ban will be holding a press conference on July 31, 2017 in front of San Francisco City Hall.
Early registration is now open for the 71st Tobacco Science Research Conference on September 17-20 in Bonita Springs, Florida.
The Global Tobacco & Nicotine Forum will be held September 12-14 in New York City.
“Although it is impossible to prove absolute safety, dozens of epidemiologic studies over three decades have documented that health risks among American chewers and dippers are not significantly elevated,” – Brad Rodu, Professor of Medicine, Endowed Chair of Tobacco Harm Reduction Research, University of Louisville.
The Proposed Tobacco Product Standard for NNN Level in Smokeless Tobacco Should Be Withdrawn
The World Health Organization’s Opposition to Tobacco Harm Reduction: A Threat to Public Health?
The Vapor Revolution: How Bottom-Up Innovation Is Saving Lives
Reason’s Research and Analysis of Nicotine and Vapor Issues