RegWatch by RegulatorWatch.com

It’s mostly a cliché to say time is a precious commodity: of course, it is. We all live under the specter of imminent demise. But cruel is life when someone or something intervenes and pronounces an abrupt end, thus stealing away time so vital to life and business.

In this episode of RegWatch we present a practical guide to FDA’s onerous Premarket Tobacco Application process which—thanks to a recent court ruling—is now due in less than 10-months. It seems that time, for the U.S. vaping industry, could be coming to an end.

Is it possible to survive the PMTA process?

Find out! Only on RegWatch, by RegulatorWatch.com.

Produced by: Brent Stafford
Released: August 6, 2019

Mountains of paperwork, clinical trials, endless frustration and most of all, heartbreak. This describes the onerous Premarket Tobacco Application process (or PMTA) now thrust upon the vaping industry by the U.S. Food and Drug Administration: it could destroy vaping as we know it.

In this RegWatch preview regulatory lawyer and FDA compliance expert, Deanna Clark-Esposito shares insight into the PMTA process and talk through some of the challenges to surviving the PMTA deadline.

**Full-length interview out next episode**

Only on RegWatch, by RegulatorWatch.com.

Produced by: Brent Stafford
Released: August 1, 2019

Where’s the evidence? It’s a simple question asked by vapers (in rare unanimity,) while suffocating under an endless torrent of inflated and distorted harms promulgated to malign vaping. At times the charges hurled from academia, public health and non-profit pressure groups appear to almost border on malevolence. And for many vapers, the strain is becoming too much the bear.

In this special edition of RegWatch see our full-length interview with Dr. Raymond Niaura, Interim Chair of the Department of Epidemiology and Professor of Social and Behavioral Sciences at NYU College of Global Public Health, and hear his full analysis of U.S. teen vaping and smoking rates; get an insiders perspective on Truth Initiative and learn what the anti-vaping pressure group knows about nicotine; and learn why Dr. Niaura believes the research on vaping as a gateway-to-smoking is a “dead-end”.

It’s time for evidence!

Only on RegWatch, by RegulatorWatch.com

Produced by: Brent Stafford
Released: July 29, 2019

It took many months before public health researchers, or members of the public, could see the data used by the U.S. Food and Drug Administration and the United States Surgeon General to raise alarm over the so-called epidemic of teen vaping.

In this RegWatch preview Dr. Raymond Niaura, Interim Chair of the Department of Epidemiology and Professor of Social and Behavioral Sciences at NYU College of Global Public Health, shares his analysis of the now released data. Find out why the results could be subject to debate.

**Full-length interview out next episode**

Only on RegWatch, by RegulatorWatch.com.

Produced by: Brent Stafford
Released: July 24, 2019

U.S. e-liquid manufacturers may have to pull millions of bottles of e-juice off of vape stores shelves following a surprise mandate, issued via tweet, by a recently appointed Republican Commissioner of the Consumer Product Safety Commission earlier this year.

The unexpected regulation covers e-liquids containing nicotine that are bottled without special “flow restricted” packaging—both plastic and glass—and comes with an immediate stop sale order that provides U.S. e-liquid manufacturers zero time to bring existing products and production lines into compliance.

Why did CPSC issue the order? What enforcement action is underway? And what is being done to help the vaping industry survive?

Find out on RegWatch by RegulatorWatch.com

Produced by: Brent Stafford
Released: July 8, 2019

When University of Waterloo professor David Hammond first shared preliminary results of his teen vaping and smoking study with Health Canada and the media in late 2018, he did so with the “hope” that his findings were just a “blip”; a sentiment he expressed at the time, and again in June 2019 when the study was finally published in the British Medical Journal.

What Professor Hammond and those he selectively shared the data with knew was that the study found a massive increase in the prevalence of teen vaping and smoking (among 16 to 19-year olds) from 2017 to 2018.

The sneak peek Hammond afforded Health Canada provided the regulator enough justification to launch a series of public consultations that are likely to end with new regulations, which may restrict adult access and choice of vaping products, in order to stem the so-called ‘epidemic’ of teen vaping.

In this special edition of RegWatch Dr. Chris Lalonde, professor of psychology at the University of Victoria, joins in an examination of the now public results, of what has become, a controversial study.

Does the study’s reported 45% increase in teen smoking square with newly released data by Statistics Canada (also in June 2019) that shows daily teen smoking is statistically near undetectable?

Is the study’s reported 74% increase in teen vaping based on relevant measures?

Find out—Only on RegWatch by RegulatorWatch.com.

Produced by: Brent Stafford
Released: July 3, 2019

It’s a huge win for the vaping industry. A Superior Court judge invalidates key provisions of Quebec's Tobacco Control Act, which promulgated harsh new regulations and fines, seemingly intended to eviscerate the vaping industry.

The ruling comes after a three-year legal challenge spearheaded by the Canadian Vaping Association, which argued the vaping restrictions infringe on the “right to security of the person” and “freedom of expression” under both the Canadian and Quebec charters of rights and freedoms.

In this episode of RegWatch hear about the ground-breaking ruling directly from Audrey Boctor the lawyer who led the fight and learn exclusive details about the court trial, expert witnesses and what happens next. Also, Daniel Marien president of the 35-store La Vape Shop retail chain joins the show to discuss the draconian rules and hear his reaction to the ruling.

Only on RegWatch by RegulatorWatch.com.

Produced by: Brent Stafford
Released: May 22, 2019

Since November 2018, when University of Waterloo Professor David Hammond first shared results of his new youth vaping study with Health Canada and the mainstream media, only one interpretation of the data has been made available to the public. And that interpretation is one of high alarm.

In February and April of 2019, Health Canada launched two separate public consultations seeking input on potential regulatory action that might stem the crisis of youth vaping. However, industry stakeholders, harm reduction advocates and members of the public had yet to be afforded access to Professor Hammond’s study in order to evaluate the data and test the interpretation.

RegWatch was provided a copy of the study by a highly-placed source within the tobacco-control community and last Thursday we published the document so that the public may see the same data, findings and conclusions being considered by regulators as they deliberate over the future of vaping in Canada and the U.S.

In this episode of RegWatch hear tobacco control policy expert Clive Bates’s analysis of the study and learn what he thinks of RegWatch’s decision to publish.

Only on RegWatch—By RegulatorWatch.com

Produced by: Brent Stafford
Released: April 29, 2019

It’s quite possibly the worst kept secret within the tight-knit ranks of tobacco-control, the research study conducted by Dr. David Hammond of the University of Waterloo, which purports to show a substantial increase in youth vaping in both Canada and the United States.

Numerous stakeholders including regulators, academics, tobacco-control activists and even the media have either seen the report or have been briefed on its findings; every one that is, except those in the vaping industry, harm reduction advocates and members of the public.

RegWatch has obtained a copy of the study and in this brief live streamed edition we are releasing it to the public so you may see the same data, findings, and conclusions being considered by regulators as they deliberate over the future of vaping in Canada and the U.S.

Download the report at RegulatorWatch.com.

Produced by: Brent Stafford
Released: April 25, 2019

***RegWatch Exclusive Interview (Part 2)***

Regulatory intervention on flavours in vaping products (i.e. a flavour ban) is ‘not’ off the table says James Van Loon, Director General of the Tobacco Control Directorate at Health Canada.

The federal regulator is considering every measure to stem the tide of youth vaping and is calling on parents, educators, youth and public stakeholders to weigh in on key issues in a consultation on potential regulatory measures to reduce youth access and appeal of vaping products in Canada.

In part-2 of our exclusive interview with Director General Van Loon, hear a detailed discussion on youth vaping statistics, flavours, nicotine salts, online sales, the upcoming federal election and much more.

Only on RegWatch by RegulatorWatch.com.

Produced by: Brent Stafford
Released: April 22, 2019