FDA Question for Bill, Re: heat-not-burn products from BT

[Nate760]

http://finance.yahoo.com/news/reynolds-launching-heat-not-burn-cigarette-160403384--finance.html

RICHMOND, Va. (AP) — Reynolds American is launching a cigarette that heats tobacco rather than burning it, hoping to capitalize on the growing appetite for alternatives to traditional smokes.

The nation's second-biggest tobacco company said Monday that it will begin selling Revo — a cigarette that uses a carbon tip that heats tobacco after being lit — in Wisconsin in February 2015. Reynolds said the cigarette is a "repositioning" of its Eclipse product first launched in the mid-1990s with minimal success.

What's the story on these as far as the "substantial equivalence" test? Do RJR/Altria get a free pass because these things bear a passing similarity to some product that was on the market for five minutes 20 years ago?

Moreover, how screamingly absurd is it that a new tobacco product (i.e. a product that actually contains tobacco) can get rubber-stamped by the same FDA that's trying to use the "substantial equivalence" test to effectively ban every vapor product (which contain no tobacco) currently on the market?

This seems to me like an issue to which we need to call attention, and for which the FDA leadership needs to be held to account. This is madness.

 

[Bill Godshall]

Nate inquired

What's the story on these as far as the "substantial equivalence" test? Do RJR/Altria get a free pass because these things bear a passing similarity to some product that was on the market for five minutes 20 years ago?

Since Eclipse/Revo doesn't fit the FSPTCA's definition of a cigarette, it is currently an unregulated tobacco product (just like cigars, pipe tobacco, hookah, dissolvables and e-cigs), and Reynolds can sell it nationwide (except perhaps in Vermont, where the State AG Bill Sorrell successfully sued Reynolds for selling Eclipse).

If the FDA approves its proposed deeming regulation, Reynolds could either submit an SE application or a new tobacco product application for Eclipse/Revo.

If Revo is the same product as Eclipse was 20 years ago, Reynolds is likely to submit an SE application, and the FDA is likely to issue an SE Order (allowing the sale of the product).

 

[Nate760]

Since Eclipse/Revo doesn't fit the FSPTCA's definition of a cigarette, it is currently an unregulated tobacco product (just like cigars, pipe tobacco, hookah, dissolvables and e-cigs), and Reynolds can sell it nationwide (except perhaps in Vermont, where the State AG Bill Sorrell successfully sued Reynolds for selling Eclipse).

If the FDA approves its proposed deeming regulation, Reynolds could either submit an SE application or a new tobacco product application for Eclipse/Revo.

If Revo is the same product as Eclipse was 20 years ago, Reynolds is likely to submit an SE application, and the FDA is likely to issue an SE Order (allowing the sale of the product).

Thanks for the thorough explanation, Bill. I was kind of afraid it was going to be along those lines.

This seems like a good time to review the last five years of FDA tobacco policy enforcement actions since the industry came under its regulatory purview under the FSPTCA:

1) Prohibited light and ultra-light cigarettes from being called "light" and "ultra-light," thus immeasurably improving the health and safety of untold millions of Americans.

2) Prohibited nicotine content from being listed on cigarette packs, since smokers are apparently better off living in a world where they have no idea how much nicotine they're consuming.

3) Outlawed four brands of a certain obscure type of Indian-made cigars, all of which had already been pulled from the market some years earlier because nobody bought them. Issued a breathlessly self-congratulatory press release about how they'd taken bold, decisive action to keep America's children safe from these no-longer-extant tobacco products that no one had ever heard of anyway.

4) Tried to unilaterally outlaw all vapor products. Got smacked down in court. Proposed deeming regulations that would, if enacted, unilaterally outlaw nearly all vapor products.

5) Meanwhile, RJR introduces a new class of tobacco product, which involves the inhalation of emissions from heated charcoal and dried tobacco leaves, and plans to sell it right across the country. FDA is utterly powerless to do anything about it.

 

[Oliver]

Ecig Intelligence is reporting that Reynolds will be seeking MRTP status....

Well, I do suppose they have 20 odd years of data.

 

[Alexander Mundy]

If it is the same as the one released in the 90's it won't be around long. Dismal failure is putting it nicely. Drove to St Louis to get a carton and they were worse than useless.

 

[Nate760]

If it is the same as the one released in the 90's it won't be around long. Dismal failure is putting it nicely. Drove to St Louis to get a carton and they were worse than useless.

I was in high school back when the first of these products (Premier) came out. My friends and I couldn't wait to try it because it seemed all advanced and futuristic. The first shock came when we found out they cost 5 bucks a pack (cigarettes were about $1.75 at that time). The second shock came when we opened the pack to find an insert that said (paraphrasing here) "Don't be alarmed when you hate this product at first. You just have to get through two or three packs and then you'll start liking them. We promise."

Needless to say, we all thought it was just about the most revolting thing we'd ever tasted. We ended up selling the rest of them for 25 cents apiece in order to recoup our investment.

 

[Bill Godshall]

Smokey Joe wrote

Ecig Intelligence is reporting that Reynolds will be seeking MRTP status....

I'd be shocked if Reynolds submitted an MRTP application to the FDA before submitting an SE application or a new tobacco product application.

And I'd be surprised if Reynolds submitted an MRTP application to the FDA before the FDA approves Eclipse/Revo as SE or as a new tobacco product.

Regardless, Reynolds isn't going to submit an SE application or a new tobacco product appication for Eclipse/Revo for several years, and will do so only if and after the FDA issues a Final Rule for its proposed deeming regulation.

 

[Bill Godshall]

Nate wrote:

Needless to say, we all thought it was just about the most revolting thing we'd ever tasted.

The only memorable line in the movie "Barbarians at the Gate" was when RJ Reynolds CEO Johnson said (about Eclipse) "They taste like ....."

ECF blocked out the last word of that sentence, which is also referred to as feces or manure.

 

[Kent C]

Nate wrote:



The only memorable line in the movie "Barbarians at the Gate" was when RJ Reynolds CEO Johnson said (about Eclipse) "They taste like ....."

".... and smells like a ....!" (flatulence)