Nicotine and Harm Reduction Newsletter – December 1, 2017

Harm Reduction Newsletter

Nicotine and Harm Reduction Newsletter – December 1, 2017

Federal Updates

Dr. Konstantinos Farsalinos, Research Fellow at the Onassis Cardiac Surgery Center in Athens, Greece wrote a highly critical letter to the Food and Drug Administration of research recently presented at an American Heart Association related to heat-not-burn tobacco products. Citing the research on the Philip Morris I-Quit-Ordinary-Smoking (IQOS) product, Farsalinos commented that “this study provides no reliable scientific information about the effects of IQOS on cardiovascular disease risk.” Dr. Farsalinos is a renowned researcher on the cardiovascular impacts of cigarettes and tobacco harm reduction products.

In a blog post published Wednesday, the FDA announced the formation of a new Nicotine Steering Committee that will be charged with “re-evaluating and modernizing FDA’s approach to development and regulation of nicotine replacement therapy products that help smokers quit.”

The FDA docket on the modified risk tobacco product (MRTP) application from Philip Morris for its IQOS heat-not-burn tobacco product remains open for public comment and will close within the next two weeks. The Reason Foundation filed a public comment with FDA in support of the application. Reason Foundation’s Brian Fojtik and Guy Bentley commented on the MRTP application here.

State Updates

Most activity across the country regarding IQOS products is occurring at the local level, with a plethora of bills banning or restricting flavored tobacco products (and vapor products) in California and “Tobacco 21” bills that would increase the age of purchase for tobacco products (and vapor products) to age 21 in Minnesota and elsewhere.

In the year-to-date, there have been approximately 140 vapor-only bills (not including flavors which also include traditional tobacco products). The top states in favor of restrictive legislation are California, Minnesota, and Massachusetts. Top Issues (in order) are vapor use restrictions (vapor bans), legal age of purchase (“Tobacco 21” bills) and general product restrictions.

There are approximately 50 local bills currently being considered that would ban the sale of flavored products at the local level.

Science and Harm Reduction

The British Medical Association published a position paper Wednesday arguing, among other things, that “there are clear potential benefits to e-cigarettes in reducing the harms associated with smoking.” The BMA advises doctors to tell their patients who ask about whether or not to switch to e-cigarettes that “while the safest option is to use neither tobacco nor e-cigarettes, there is no situation in which it is safer to continue smoking than to use an e-cigarette.”


Reason’s Brian Fojtik published an article in the Huffington Post arguing that a change in the predicate for vapor products to August 8, 2016, would be a significant step forward for allowing smokers to switch from cigarettes to reduced risk vapor products.

Quotable Quotes

“There is no apparent limit to how low tobacco control will go in pursuit of their special-interest activism,” – Carl V. Phillips

What’s Coming Up

On December 6-8, American Legislative Exchange Council (ALEC) will be holding its Nation & States Policy Summit in Nashville, TN.

On December 12, 2017, the Duke-Margolis Center for Health Policy will hold a public event to discuss the FDA’s regulatory approach to medicinal nicotine. FDA Commissioner Scott Gottlieb and Director of the Center for Tobacco Products at FDA Mitch Zeller will be speaking at the event.

Keller and Heckman LLP, a Washington, DC-based firm that specializes in regulatory and FDA issues for vapor product manufacturers, distributors and retailers will be hosting an E-Vapor and Tobacco Law Symposium in Irvine, California on February 6-7, 2018. Agenda and registration information for the symposium can be found here.

Additional Resources

Comment to FDA on Modified Risk Tobacco Product Application

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