Connecticut to investigate Juul labs

[zoiDman]

Altria shares slide amid accelerating decline in cigarette sales and concerns over Juul investment
The FDA's review process calls for the agency to weigh the net public health benefit — meaning it needs to weigh how many adults will benefit from the product versus how many teens might be harmed — when deciding whether to allow products to stay on the market.

Juul And Rivals, Given 10 Months To Submit FDA Application, Face Battle To Keep Selling E-Cigs
Ex-FDA Chief Gottlieb Doubts juul’s Chances

Meet Scott Gottlieb’s Successor at FDA - Vaping360
There is no reason to think Sharpless will veer far from Gottlieb’s vision for FDA tobacco and vape regulation. In fact, the White House has made it clear that the Trump administration will follow Gottlieb’s lead.

IWF -FDA’s Sharpless will not be kind to vaping
“Sharpless has been supportive of Gottlieb’s efforts to ban vaping products,”

Below we see the CDC's very clear position ...

Quick Facts on the Risks of E-cigarettes for Young People
Why Is Nicotine Unsafe for Kids, Teens, and Young Adults?

• Most e-cigarettes contain nicotine—the addictive drug in regular cigarettes, cigars, and other tobacco products.
• Nicotine can harm the developing adolescent brain.1 The brain keeps developing until about age 25.
• Using nicotine in adolescence can harm the parts of the brain that control attention, learning, mood, and impulse control.1
• Each time a new memory is created or a new skill is learned, stronger connections – or synapses – are built between brain cells. Young people’s brains build synapses faster than adult brains. Nicotine changes the way these synapses are formed.
• Using nicotine in adolescence may also increase risk for future addiction to other drugs.1

So, unless a new FDA commissioner takes over (which can happen), it seems Juul is f'd! ¯\_(ツ)_/¯

BTW - This has been a Rumor that I have been following for the Last Month or so. Now it looks like it Isn't a Rumor.

Philip Morris International, Altria confirm they are in merger talks to reunite

Who said You can Never Go Back?

LOL

 

[iVapeDIY]

BTW - This has been a Rumor that I have been following for the Last Month or so. Now it looks like it Isn't a Rumor.

Philip Morris International, Altria confirm they are in merger talks to reunite

Who said You can Never Go Back?

LOL

Interesting timing. PMI can get Altria assets on the cheap (buy low).

Since PMI owns iQOS, will they throw Juul under the bus (US only) and push iQOS? Juul is getting footholds in Indonesia, South Korea and the Philippines; this sets up iQOS and Juul to co-exist.

 

[iVapeDIY]

Philip Morris and Altria gamble on post-cigarette future
Subscribe to read | Financial Times

Note: Copy news headline and 'search' it to get a refresh of full article

One of the biggest hurdles in the path of a successful PMI-Altria recombination is the uncertainty about how regulators will treat the new products on which the industry’s growth depends.

In April, the US Food and Drug Administration authorised Altria to start selling PMI’s Iqos heated tobacco system in the US, but analysts are concerned that the regulator could clamp down on the ecigarette market, after warning of an “epidemic” of youth vaping.

Ryan Tomkins, an analyst at Citigroup, said that the biggest threat to the deal was the FDA, which has focused its efforts to curtail vaping on Juul in particular due to its popularity among teenagers and is investigating reports tying seizures to vaping use.

Mr Tomkins added that a Centers for Disease Control and Prevention survey of youth tobacco use in the US was due out any day, “the results for which could be dangerous for Juul”.

 

[zoiDman]

Interesting timing. PMI can get Altria assets on the cheap (buy low).

Since PMI owns iQOS, will they throw Juul under the bus (US only) and push iQOS? Juul is getting footholds in Indonesia, South Korea and the Philippines; this sets up iQOS and Juul to co-exist.

So as to Not to Derail this thread any more than I have already, I posted a reply here...

A Consolidation of the Chess Pieces?

 

[iVapeDIY]

Mysterious vaping lung injuries may have flown under regulatory radar

Asked about the lung injuries appearing now, Gottlieb, who left the FDA in April, said he suspected counterfeit pods are to blame, given the geographic clustering of cases and the fact that, overall, the FDA is inspecting registered e-cigarette makers and retailers to make sure they’re complying with existing regulations.

“I think the manufacturers are culpable if their products are being used, whether the liquids are counterfeit or real,” he said. “Ultimately, they’re responsible for keeping their products out of the hands of kids.”

Interesting implications ... Juul and other original pod makers will be liable for all fatalities and injuries caused by counterfeit pods.

 

[bombastinator]

Mysterious vaping lung injuries may have flown under regulatory radar

Asked about the lung injuries appearing now, Gottlieb, who left the FDA in April, said he suspected counterfeit pods are to blame, given the geographic clustering of cases and the fact that, overall, the FDA is inspecting registered e-cigarette makers and retailers to make sure they’re complying with existing regulations.

“I think the manufacturers are culpable if their products are being used, whether the liquids are counterfeit or real,” he said. “Ultimately, they’re responsible for keeping their products out of the hands of kids.”

Interesting implications ... Juul and other original pod makers will be liable for all fatalities and injuries caused by counterfeit pods.

Isn’t gottleib now part of the board of some pharmaceutical company now and no longer gets FDA info? His attitude may or may not have anything to do with the way the FDA is actually going to jump. He’s both out of date and serves a different master now.

 

[zoiDman]

...

“I think the manufacturers are culpable if their products are being used, whether the liquids are counterfeit or real,” he said. “Ultimately, they’re responsible for keeping their products out of the hands of kids.”

...

If this was said by some Emotionally Clouded, Uninformed, High School Student Body President, it would almost be Laughable. But coming form the Former Head of the FDA?

Seriously?

If he Actually said this, then I am more than Glad he is a Former and Not the Current.

It's like say'n that If I took Old Whiskey Bottles and filled them with Bathtub Booze to sell them on the Black Market, that Somehow Jack Daniels should be Held Liable if someone got Sick.

Gimmie a ...ing Break.

BTW - Did our friend Scott happen to mention what the Legal Precedent is for such Culpability?

Spoiler

Of course he Didn't. Because there Isn't.

 

[iVapeDIY]

Former FDA head blames counterfeit e-cigarettes for rise in vape-related lung disease

"The legal vapes have been actively regulated by FDA since Aug 2017. FDA has conducted thousands of inspections of manufacturers and vape stores, published manufacturing guidance, sought product removals etc. These tragedies point to illegal vapes and ," former FDA Commissioner Scott Gottlieb wrote on Twitter Tuesday night.

"Health officials can target imports and conduct blitzes at international mail facilities to try and capture, shut down more illegal and counterfeit vapes and source some of the dangerous products. There are already published FDA lists of known dangerous ingredients to look for," he continued.

Hmmm ... Post Office raids.