RegWatch by RegulatorWatch.com

*** with Dr. Michael Siegel *** The past few weeks have been horrific for the approximately 400 victims (and families) poisoned by illicit THC-vaping products—some fatally. It’s a real tragedy and certainly a public health emergency. But these are not the only victims; tens of millions of people who rely on traditional nicotine-vaping products as a lifeline to quit smoking (or to stay quit) now find access to these products threatened, or in the case of the state of Michigan, revoked, restricted, denied.

In this edition of RegWatch Dr. Siegel evaluates FDA, CDC and non-profit health groups’ lack of clarity regarding the nature of the emergency; an emergency which should have first, and only, been described as a product tampering or tainted product crisis. Instead, health officials warned the public to stop using e-cigarettes; maligning traditional nicotine-vaping and obscuring the truth.

What caused these illnesses? And, why does it appear the CDC is doing everything in its power to protect the illicit THC-vape trade while deflecting blame onto the legal, retail vaping industry?

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

***FULL INTERVIEW***

Produced by: Brent Stafford
Released: September 10, 2019

Weeks prior to the first cases of vaping-related lung illness hitting the news, RegWatch conducted an exclusive interview with Martin Dockrell the Tobacco Programme Lead at Public Health England.

PHE is the UK’s top health protection agency and employs 5,000 staff who are mostly scientists, researchers, and public health professionals. Public Health England is a beacon of sound science and for the past 5-years has a been a strong advocate for the use of e-cigarettes as a tool to stop smoking.

While the recent deaths and illnesses associated with vaping are tragic, the confounding of traditional nicotine-vaping with illicit black-market THC-vaping could have dire consequences.

In this snippet of our exclusive interview with Public Health England, hear Dockrell discuss how vaping is 95% less harmful than smoking and learn the science behind this determination.

Only on RegWatch, by RegulatorWatch.com.

Produced by: Brent Stafford
Released: September 7, 2019

It’s a logical conclusion, following a year of incessant misinformation and media hype over the so-called epidemic of teen vaping and the recent crisis over vaping-related lung disease—it seems the epidemic rhetoric has finally metastasized into the desired result: an out-right-ban on vaping products.

On Wednesday Democratic Governor Gretchen Whitmer issued an executive order banning the sale of flavored e-cigarettes across Michigan, in an effort to discourage teens and other young people from vaping. The governor says it’s a public health emergency and she has the unilateral power to ban vaping in her state.

Is this order legal? What will be the impact? And, could Michigan set a dangerous precedent for other states to follow?

Gregory Conley, President of the American Vaping Association joins RegWatch to discuss these questions and hear Gov. Whitmer explain the rationale behind her decision.

Only on RegWatch, by RegulatorWatch.com.

Produced by: Brent Stafford
Released: September 5, 2019

Progressives’ war on vaping escalated to a new and dangerous phase in the past few weeks, going well beyond mere misinformation and hysterical rhetoric. According to the U.S. Centers for Disease Control, nearly 100 people, mostly teens, have been hospitalized with severe lung damaged; apparently the result of vaping.

The allegations have made national news, yet medical officials say they do not know what products, brands or substances were being used. So how then is the CDC able to blame vaping?

In this headline edition of RegWatch we talk with Dr. Riccardo Polosa, Director of the Institute for Internal Medicine & Clinical Immunology at University of Catania, Italy. Dr. Polosa is the world’s foremost researcher studying the effects of vaping on the respiratory system, and in this episode learn why he thinks these allegations of vaping-related lung damage are beyond credible.

Only on RegWatch, by RegulatorWatch.com.

Produced by: Brent Stafford
Released: August 21, 2019

If your house is on fire, is it worth it to worry, about the fire-resistance rating of your living room sofa set? It might be, depending on which room the fire is burning and whether your escape route runs past the living room couch. This type of calculation now besets both the U.S. and Canadian vaping industries.

In this episode of RegWatch hear how an alliance of vaping associations from north and south of the border are working to establish a unified set of standards for Good Manufacturing Practices, ready-made, for the U.S. Food and Drug Administration and Health Canada to embrace.

Could manufacturing standards that are fit for purpose, help douse the cross-border fire which currently engulfs vaping?

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

Produced by: Brent Stafford
Released: August 17, 2019

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