Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap

From: US FDA

by Scott Gottlieb, MD, Commissioner of Food and Drugs


These are just some of the extraordinary advances that are transforming health. But we also face challenges as we strive to ensure that Americans have access to these and other opportunities.  Both the time and the cost of medical product development continues to rise for many types of products. We know that the cost of product development can impact how such products are priced, and can be a factor in limiting patients’ ability to get timely access to beneficial new treatments and services. At the same time, FDA faces new public health challenges. Principal among them is the ongoing crisis of opioid addiction. We also continue to face too much avoidable death and disease associated with smoking tobacco; and children are still becoming initiated on, and addicted to, nicotine.

New Year = New Regulations

From: Convenience Store Decisions

C-stores face more restrictions and taxes on cigarettes in 2018.

By Anne Baye Ericksen, Contributing Editor

As of Jan. 1, smokers in Aspen, Colo., are paying $3 more per pack of cigarettes than they did last month. Also, Oregonians must now be 21 in order to purchase any type of tobacco products in the state. That’s two different communities and two different regulatory policies, but it all adds up to one thing in 2018: The cigarette category faces more pressure than ever before.

Say hello to nonaddictive cigarettes?

Editor’s Note: Cross-posted from OIRA Watch.

From: Scientific American

Watch for These 7 U.S. Science Regulations/Deregulations in 2018

These changes could have serious consequences for health, food and safety

By Dina Fine Maron


US study: Indoor vaping bans lead to more prenatal smoking

From: Vaping Post

A recent study by Georgia State University economist Michael Pesko, found that laws restricting vaping at places of employment and entertainment, increase the chances of smoking in pregnant women by as much as 30%.

By Diane Caruana

“Pregnant women are highly motivated to quit smoking cigarettes and may believe e-cigarettes are a safe way to do so,” said Pesko, who is an assistant professor at the university’s Andrew Young School of Policy Studies.

Advancing Medicinal Nicotine Replacement Therapies as New Drugs – A new step in FDA’s comprehensive approach to tobacco and nicotine

From: FDA Voice

By: Scott Gottlieb, M.D., Janet Woodcock, M.D., Mitchell Zeller, J.D.

As the leading cause of preventable disease and death in the United States, tobacco causes more than 480,000 deaths every year. To address this devastation, earlier this year FDA announced a new regulatory plan to lower this burden of tobacco-related disease and death. The plan takes a comprehensive approach to nicotine and tobacco, including an initiative to lower nicotine in cigarettes to minimally addictive or non-addictive levels. Aimed at shifting the trajectory of tobacco-related disease and death, the agency’s approach recognizes that nicotine is delivered through products posing a continuum of risk. This ranges from combusted cigarettes at one end, to nicotine replacement therapy (NRT) products – designed to safely reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking – at the other.