February 6th, 2018
From: CSP Daily News
Tobacco Regulation Report | The Face(s) of Tobacco Regulation
***
“We believe our approach in this final rule is both reasonable and balanced,” Zeller said in a public statement. “This historic rule allows the FDA to use a variety of regulatory tools to improve public health and protect future generations from the dangers of tobacco use.”
Other notable regulatory actions credited to Zeller include:
—The FDA’s first-ever SE and PMTA approvals.
—The FDA’s first-ever Not Substantially Equivalent (NSE) orders removing products from the market.
—The FDA’s first-ever No Tobacco Sale Orders to tobacco retailers failing multiple inspections.
January 26th, 2018
From: Benzinga
Elizabeth Balboa
***
What’s Next
“We still think FDA will ultimately approve the PMTA as soon as next month and MRTP later in the summer for IQOS,” Miller said in a note.
Piper Jaffray agreed, noting that the regulatory body does not appear to present insurmountable roadblocks.
Read Complete Article
January 17th, 2018
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.
January 10th, 2018
From: Convenience Store Decisions
Anne Baye Ericksen
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.
December 21st, 2017
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
***
