Discussion in 'FDA Regulations' started by sofarsogood, Jul 26, 2018.
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Reynolds' latest heat-not-burn cigarette could get test market by year's end after FDA move
Wasn't Eclipse a major flop when it was marketed in the early 2000's?
Calling a product "Heat not Burn" when there's burning charcoal on the end of it strikes me as somewhat disingenuous. The carbon monoxide in smoke is likely responsible for a considerable portion of the health consequences of smoking, and I would expect the burning charcoal to produce substantial amounts of it.
I'd try IQOS, but not this.
And still no Swedish Snus... for shame for shame FDA.
I have been waiting to see someone do a Successful SE Application.
"BAT said in its fiscal 2018 first-half earnings report that Food and Drug Administration market authorization “clearance has been received (July 19) for two substantial equivalence applications for our improved carbon tipped tobacco heating product.”
A substantial-equivalence filing is for products that either have the same characteristics as those marketed on/before Feb. 15, 2007, or have different characteristics but do not raise different questions of public health."
The important thing is not whether it's a good product but that FDA approved it.
BTW - If it is Like a Million Degrees outside, and you are Stuck inside with an A/C racking up Big Bucks on your Electric Bill, this is kinda Interesting if you have 56 Minutes to kill.
It talks about the Eclipse saga. And there is a much younger Mitch Zeller getting all High and Mighty say'n that we have to do Everything Possible to promote "Safer Alternatives" to Smoking. Instead of Standing in the Way and putting up Road Blocks to Technology.
BTW2 - That episode of NOVA first aired on October 2, 2001.
And Greg Connolly...
But I'll note that Mitch was also already talking about how such products might lure people who might otherwise not smoke into becoming addicts, how they might keep people who would otherwise quit from doing so, and how they might cause those who had already quit to go back to "smoking".
Overall though, that video was very interesting! It seems that BT had the idea of heating a mixture of glycerin and nicotine well before the the Chinese did, even if it was done quite crudely in a glass tube over a flame. I'm also surprised how early they were trying to do electrical Heat not Burn products, but the tech (batteries and electronics) were obviously not ready for prime time then...
Yeah... I stumbled across it while browsing NOVA Episodes on Netflix. I was Pleasantly Surprised when it Finally arrived.
All the Things that Zeller brought up were just as Relevant then as the are Now. The Difference being is there is a Better Understanding about Never-Smokers and Nicotine Chemical Dependency. Dependency but perhaps not Addiction.
What I found Sad was how Zeller seemed sincere about wanting to (then) promote HRT and Innovation as an Alternative to a 100% Combustible Cigarette Market. Whereas today, he has been Instrumental in crafting the Sword of Damocles Regulations that we live under.
Those Heat Not Burn Prototypes were almost Comical to look at. But then again, when I look at the Inside of an Old Tube Radio, I kinda get the same Grin on My face.
ETA: Also Very Sad that so Many Understood in 2001 that it Wasn't the Nicotine that was the real carrier of Harm. It was the Combustion.
But when e-Cigarettes hit the Scene in 2008, and started to gain traction in 2009, the same old FUD Based Campaigns were launched as a means to Quash Vaping.
And are Still used to this Day.
I don't recall Mitch Zeller (who I collaborated with on FDA's 1996 tobacco regulation until it was struck down by the SCOTUS in 2000) opposing noncombustible THR products until he began working as a lobbyist for GlaxoSmithKline in 2002 (via Pinney Associates).
In 2003/04, GSK's Zeller and CTFK's Matt Myers (who was financed by RWJF/J&J) negotiated and agreed to the Tobacco Control Act legislation with Philip Morris lawyer Mark Berlind, which was introduced by Waxman and Kennedy in 2004 (to purportedly protect another generation of youth from Big Tobacco). But in fact, the TCA has protected PM's Marlboro cigarette monopoly and GSK/J&J's Nicorette and Nicoderm monopoly from market competition by low risk smokefree tobacco products.
Jack Henningfield (also featured in the NOVA piece) was also a GSK lobbyist (also via Pinney Associates) who demonized smokeless tobacco products and falsely claimed they were unsafe alternatives to cigarettes.
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