FDA demands review of newer tobacco products- Front Page MSNBC

[jagstang]

But as long as they were marketing their products before (whatever month it was) 2007, they don't have to apply for review, do they? I don't know the answer. I'm asking.

Depends on how you read it. I dunno but the heating source wording can only be one thing I can think of.

tobacco products introduced or altered since February 2007 must be reviewed by the U.S. Food and Drug Administration if they are to remain on the market, the agency announced Wednesday.


This effort, one aspect of the 2009 Family Smoking Prevention and tobacco Control Act, is meant to keep more addictive products from the hands of consumers. Any new or revised tobacco products must be substantially equivalent to products sold on or before Feb. 15, 2007, the agency said.

 

[jagstang]

The FDA doesn't have the power to contraband an international item or stop its shipment to the states, although I am sure they would like to have that power.

Ken

Pretty sure they already ordered a ban of the imports. The courts just said "no" until it could be worked out in court. An the courts said to treat it like tobacco. And now they are it seems.

 

[devilock76]

Pretty sure they already ordered a ban of the imports. The courts just said "no" until it could be worked out in court. An the courts said to treat it like tobacco. And now they are it seems.

Yes but see they had to go to the court to get a ban on it. This can be challenged as well in court. But beside that the FDA has no authority to regulate international commerce. Which means they could never actually stop a chinese supplier from selling to a US resident.

Ken

 

[jj2]

According to Wikipedia the e-cig was invented in China in 2003 and marketed the next year.

Anyone know when it was actually introduced into the U. S.?

I can only assume it had to be pre 2007.

 

[jagstang]

It appears the FDA does have the power but has rarely used it. Here is just the first hit from Google ...

Nation & World | FDA blocks tainted seafood from China | Seattle Times Newspaper

Edit: Actually the more I read ... The FDA does this a lot more than I thought.

 

[FieryOne]

Interesting. The article is extremely vague and I can't really tell what it means to us.

 

[devilock76]

It appears the FDA does have the power but has rarely used it. Here is just the first hit from Google ...

Nation & World | FDA blocks tainted seafood from China | Seattle Times Newspaper

Commercial example, how about to a private home. For example flavored cigarettes were banned in stores, like say cloves. So they now call them flavored cigars, and they changed the paper. However you can go online and have clove cigarettes (actual cigarettes) shipped to you from overseas, even though it is an FDA banned item.

Ken

 

[kristin]

Yes but see they had to go to the court to get a ban on it. This can be challenged as well in court. But beside that the FDA has no authority to regulate international commerce. Which means they could never actually stop a chinese supplier from selling to a US resident.

Ken

Actually, the FDA just started seizing e-cigarette imports without any court order. (March 2009: FDA adds electronic cigarettes to Import Alert 66-41 and directed the USCBP to reject the entry of electronic cigarettes into the United States.) See timeline at: CASAA.org/resources

The companies whose products were seized took the FDA to court to get their stuff and stop the FDA from blocking the imports.

 

[yvilla]

Here is the FDA guidance document on the "substantial equivalence" provision:

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM239021.pdf

 

[devilock76]

Actually, the FDA just started seizing e-cigarette imports without any court order. (March 2009: FDA adds electronic cigarettes to Import Alert 66-41 and directed the USCBP to reject the entry of electronic cigarettes into the United States.) See timeline at: CASAA.org/resources

The companies whose products were seized took the FDA to court to get their stuff and stop the FDA from blocking the imports.

I guess I never realized they had that much power to abuse. I guess big pharma money can go a long way.

Ken

 

[jagstang]

Actually, the FDA just started seizing e-cigarette imports without any court order. (March 2009: FDA adds electronic cigarettes to Import Alert 66-41 and directed the USCBP to reject the entry of electronic cigarettes into the United States.) See timeline at: CASAA.org/resources

The companies whose products were seized took the FDA to court to get their stuff and stop the FDA from blocking the imports.

Sorry. that is pretty much what I was trying to say. I am just trying to do my work at the same time. the only thing different I was trying to say was that the courts said you must treat it like tobacco and it appears that is exactly what they are attempting to do by calling it a "new tobacco" product.

 

[sherid]

Perhaps that's why ploom got started. It's predecessor,
high-tech cigarettes Despite such criticism, the major cigarette makers have attempted to market several versions of safer cigarettes. In 1988, RJR introduced a high-tech cigarette called Premier. Premier, touted as a virtually smokeless cigarette that dramatically reduced the cancer-causing compounds inhaled by smokers, was made of aluminum capsules that contained tobacco pellets. The pellets were heated instead of burned, thereby producing less smoke and ash than traditional cigarettes. Although the product looked like a traditional cigarette, it required its own instruction booklet showing consumers how to light it.

and
Despite those setbacks, both RJR and Philip Morris have tried again with high-tech versions of smokeless cigarettes. In 1994, RJR began testing the Eclipse smokeless cigarette, which claimed to reduce secondhand smoke by 85 to 90 percent. Eclipse is more like an ordinary cigarette than its predecessor Premier because it contains tobacco and reconstituted tobacco. But it also includes a charcoal tip that, when lighted, heats glycerin added to the cigarette but does not burn the tobacco. The result is a cigarette that emits tobacco flavor without creating ash and smoke. But RJR isn't touting Eclipse as a safe cigarette, instead marketing it as a more socially acceptable product less offensive to non-smokers. Indeed, because Eclipse still burns some tobacco, it has tar levels similar to those of ultra-light cigarettes already on the market. Eclipse emits lower tar levels of cancer-causing compounds than many existing cigarettes, but it still produces carbon monoxide and nicotine. And questions have also been raised about the effects of heating glycerin. When burned, glycerin is known to be carcinogenic. It also remains unclear whether the FDA will attempt to regulate Eclipse if RJR launches it nationally.

Philip Morris is testing its own high-tech cigarette called Accord, which has been described as a cigarette encased in a kazoo-shaped lighter. Consumers buy a $40 kit that includes a battery charger, a puff-activated lighter that holds the cigarette, and a carton of special cigarettes. To smoke the cigarettes, a smoker sucks on the kazoolike box. A microchip senses the puff and sends a burst of heat to the cigarette. The process gives the smoker one drag and does not create ashes or smoke. An illuminated display shows the number of puffs remaining, and the batteries must be recharged after every pack. It's unclear whether smokers will find the low-smoke and -ash benefits desirable enough to justify learning an entirely new smoking ritual. Although Philip Morris doesn't make health claims about Accord, the company in 1998 told the Society of Toxicology that Accord generated 83 percent fewer toxins than a regular cigarette.

NOVA Online | Search for a Safe Cigarette | "Safer" Cigarettes: A History

My guess is that Ploom and BT's own versions based upon past experiments will corner the market. They were developed long before 2007 and use actual tobacco. Prepare for an announcement.

 

[jagstang]

Here is the FDA guidance document on the "substantial equivalence" provision:

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM239021.pdf

Interesting wording here ...

A tobacco product may not be found to be substantially equivalent to a predicate tobacco
product that has been removed from the market at the initiative of the FDA or that has
been determined by a judicial order to be misbranded or adulterated

 

[devilock76]

Interesting wording here ...

A tobacco product may not be found to be substantially equivalent to a predicate tobacco
product that has been removed from the market at the initiative of the FDA or that has
been determined by a judicial order to be misbranded or adulterated

Some other bits

Tobacco product means “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)” (section 201(rr)(1) of the Act. Thus, the term is not limited to products containing tobacco, but also includes components, parts, or accessories of tobacco products, whether they are sold for further manufacturing or for consumer use. For example, tobacco, papers, and filters are tobacco products, whether they are sold to consumers for use with roll-your-own tobacco or are sold for further manufacturing into a product sold to a consumer, such as a cigarette. This term does not include an article that is a drug, a device, or a combination product as defined in the FD&C Act (section 201(rr)(2) of the FD&C Act (21 USC 321(rr)(2)).

So it looks like the PV's themselves are ok. It is about the juice.

Further more it goes on to explain that such blending alternatives are acceptable as in changes of blends are ok and it states that the a new manufacturer only needs to show it is equivalent to something already marketed in the US by 2007, which I am POSITIVE there were e-cigs marketed in the US by 2007 and hence e-liquid.

Ken

 

[kristin]

Here is the FDA guidance document on the "substantial equivalence" provision:

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM239021.pdf

Thanks, Yolanda, I was hoping you'd chime in. I'm going over this now, but my guess this is more directed at products such as U.S. snus, Orbs, strips, etc. Have you had a chance to look at it Yolanda? What's your take?

Neither the FDA nor the courts have officially ruled e-cigarettes to be tobacco products yet - although it looks like they are heading that way and this would edefinitely affect them, because e-cigarettes are nothing like any other tobacco product.

 

[kristin]

Sorry. that is pretty much what I was trying to say. I am just trying to do my work at the same time. the only thing different I was trying to say was that the courts said you must treat it like tobacco and it appears that is exactly what they are attempting to do by calling it a "new tobacco" product.

No, it was my fault - I accidentally quoted your post instead of devilok76's post, but fixed it after. You had it right!

 

[Vocalek]

Sottera, Inc., doing business as NJOY, manufactures and distributes microelectronic alternative smoking devices for tobacco smokers. The company markets its products through distributors, independent sales representatives, and affiliate programs, as well as online in the United Kingdom, the European Union, the United States, Canada, and Mexico. Sottera, Inc. was founded in 2006 and is based in Scottsdale, Arizona.

 

[Aaeli]

Maybe I'm misunderstanding but aren't they saying that the "product" is not grandfathered if it has changed since 2007? Wouldn't that include things like changing nicotine extraction methods and/or pv design changes since 07?

 

[jagstang]

Interesting wording here ...

A tobacco product may not be found to be substantially equivalent to a predicate tobacco
product that has been removed from the market at the initiative of the FDA or that has
been determined by a judicial order to be misbranded or adulterated

Don't know why I am so focused on the heating source part but this is from the pdf ...

6. Description of Heating Source
The 905(j) report should provide a description of the heating source (e.g., burning
coal, electric, chemical reaction, carbon tip) used in the consumption of the
finished tobacco product. If the heating source of the new tobacco product differs
from that of the predicate tobacco product and, if applicable, from the
grandfathered tobacco product, this description should be in enough detail to
demonstrate that the change in heating source does not raise different questions of
public health.

 

[kristin]

Sottera, Inc., doing business as NJOY, manufactures and distributes microelectronic alternative smoking devices for tobacco smokers. The company markets its products through distributors, independent sales representatives, and affiliate programs, as well as online in the United Kingdom, the European Union, the United States, Canada, and Mexico. Sottera, Inc. was founded in 2006 and is based in Scottsdale, Arizona.

Which means, if I'm reading correctly, that other e-cigs that are based on the same technology and delivery would be able to use Njoy as a pre-existing product.

However, the paper Yolanda posted doesn't acknowledge e-cigarettes as a tobacco product, either. They still fall under drug devices....for now.