FDA issues first orders to stop sale, distribution of tobacco products

[pamdis]

Almost three years after the required SE applications were required to be filed...

FDA issues first orders to stop sale, distribution of tobacco products

The U.S. Food and Drug Administration issued orders today to stop the further sale and distribution of four tobacco products currently on the market. The action marks the first time the FDA has used its authority under the Family Smoking Prevention and tobacco Control Act to order a manufacturer of currently available tobacco products to stop selling and distributing them.

 

[rothenbj]

Aw yes, the long arm of the "law" reaches out and closes down the little guy to further protect BT. I wonder if the minority Indian population can claim discrimination.

 

[Kent C]

The wording is chilling and perhaps a 'preview' of certain brands of ecigs, mods, ejuice, etc.

"Companies have an obligation to comply with the law** – in this case, by providing evidence to support an SE application,” said Zeller. “Because the company failed to meet the requirement of the Tobacco Control Act, the FDA’s decision means that, regardless of when the products were manufactured, these four products can no longer be legally imported or sold or distributed through interstate commerce in the United States.”

And the 'snitch policy,' aka the 'attack the competition' clause:

"Consumers and other interested parties can report a potential tobacco-related violation of the Food, Drug & Cosmetic Act, including NSE products that continue to be sold or distributed in the United States, by using the FDA’s Potential Tobacco Product Violation Reporting Form."

Our country was formed to allow free exchange of ideas and products. What happened!?!? (that's rhetorical... I know what happened


** How about Obama's "obligation to comply with" the Affordable Care Act? ... rather than issuing waivers that violate the law as written and as passed, so it doesn't affect any Democrat until after certain elections? Oh.. that's different...

 

[DrMA]

Which products were involved? Is there a link to the full story?

 

[jamie]

Which products were involved? Is there a link to the full story?

Yes, the link is in the first post above. The story says "The products – Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone"

 

[03FXDWG]

They come/came in flavors which aren't allowed and they're from India, not native american Indians. This isn't the first time they've jumped on flavored cigarettes. How long has it been since you've seen a clove cigarette?

 

[AgentAnia]

Wow! They ruled on four count 'em four products! Major whiplash...

At this rate, the sun will go nova before they finish up *existing* applications, never mind those to come...

 

[DrMA]

Yes, the link is in the first post above. The story says "The products – Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone"

For some reason that didn't show up on Tapatalk, but I can see it now on the PC.

 

[440BB]

Wow! They ruled on four count 'em four products! Major whiplash...

At this rate, the sun will go nova before they finish up *existing* applications, never mind those to come...

They can take their time, I'm OK with that!

 

[stevegmu]

Aw yes, the long arm of the "law" reaches out and closes down the little guy to further protect BT. I wonder if the minority Indian population can claim discrimination.

I've seen how bidis are made on a tv show. Children rolling them, while the owner of the 'factory' lives in a walled off compound.

 

[Jman8]

How long has it been since you've seen a clove cigarette?

Since I had one? About 5 months.

Since I've seen one? About 2 weeks.

 

[rothenbj]

I've seen how bidis are made on a tv show. Children rolling them, while the owner of the 'factory' lives in a walled off compound.

Perhaps President Pranab Mukherjee will issue an executive order and increase their pay to 627.51 rupees per hour.

 

[Kent C]

I've seen how bidis are made on a tv show. Children rolling them, while the owner of the 'factory' lives in a walled off compound.

Another "exploitation of the poor" story. By our standards, it's deplorable, but to the actual workers - mainly women, it's like any other cottage industry in poor countries, they have their children help them and for most, it's the only source of income available to them, or the alternatives are even worse.

Labour Bureau Government of India

 

[twgbonehead]

In this case, it sounds like the Manufacturer messed up. Bidis have been on the market in the US for a very long time; I remember them being popular among a few friends of mine in college.

According to the release, the manufacturer did not provide any examples of similar products that were on the market before the deadline. The ruling is pro-forma. "Don't give us the info we ask for, we'll ban them". I don't think in this particular case, the FDA is actually to blame.

 

[twgbonehead]

I've seen how bidis are made on a tv show. Children rolling them, while the owner of the 'factory' lives in a walled off compound.

Sadly, much of India is like that. An extremely wealthy small group of the higher castes, who live in walled and guarded compounds. An enormous mass of extremely poor doing whatever they can to keep food on their children. On a more positive note, high-tech is actually helping to create much more of what we would probably consider "lower-middle-class" - Programmers, engineers, call-center staff. These opportunities just didn't exist not too long ago.

 

[Kent C]

The ruling is pro-forma. "Don't give us the info we ask for, we'll ban them". I don't think in this particular case, the FDA is actually to blame.

Our small vendors may be confronted with the same ruling, and it might not be worth their time, effort or money. For Njoy and Blu, it may be.

eta: some of the same ploys were used - increase in kids' use and perhaps a 'gateway' to regular cigs.

 

[Roger_Lafayette]

Perhaps President Pranab Mukherjee will issue an executive order and increase their pay to 627.51 rupees per hour.

[Actually the person you want is P.M. Manmohan Singh. Indian Pres is basically a figurehead similar to monarchs in some European countires - UK, Spain come to mind.]

ANyway, just some background on "substantial equivalence" - which will likely be applied to e-juice in the future - from my media roundup last week ... (for those of you who are gluttons for this sort of masochistic punishment

http://www.fda.gov/TobaccoProducts/...duct: Responses to Frequently Asked Questions and for the scope of FDA authority under the Family Smoking Prevention and Tobacco Control Act, see:
Family Smoking Prevention And Tobacco Control Act

Glantz & his ilk are pressuring the FDA to be more picky about it - see: http://www.tobacco.ucsf.edu/
fda-should-be-careful-about-granting-exemptions-substantial-equivalence-applications

 

[Bill Godshall]

Kent wrote

Our small vendors may be confronted with the same ruling, and it might not be worth their time, effort or money. For Njoy and Blu, it may be.

An important correction, as ALL e-cig products and companies WILL BE confronted with the same ruling if FDA imposes the deeming regulation on e-cigs.

That's why I drafted and posted the following alert.

Action Alert: Urge Congress to prevent FDA from banning e-cigarettes again and to stop FDA from giving the e-cig industry to Big Tobacco
http://www.e-cigarette-forum.com/fo...op-fda-giving-e-cig-industry-big-tobacco.html

Anyone who truly cares about keeping e-cigs legal should contact their members of Congress, and urge them to oppose FDA's potentially forthcoming e-cig ban (that FDA and ANTZ decietfully call a "regulation to protect children").

Op/eds and letters to newspaper editors can also be helpful.

 

[Kent C]

Kent wrote



An important correction, as ALL e-cig products and companies WILL BE confronted with the same ruling if FDA imposes the deeming regulation on e-cigs.

That's why I drafted and posted the following alert.

Action Alert: Urge Congress to prevent FDA from banning e-cigarettes again and to stop FDA from giving the e-cig industry to Big Tobacco
http://www.e-cigarette-forum.com/fo...op-fda-giving-e-cig-industry-big-tobacco.html

Anyone who truly cares about keeping e-cigs legal should contact their members of Congress, and urge them to oppose FDA's potentially forthcoming e-cig ban (that FDA and ANTZ decietfully call a "regulation to protect children").

Op/eds and letters to newspaper editors can also be helpful.

Bill,

I agree with what you say about the deeming regulation. Here I was referring to the statement by Zeller above:

"Companies have an obligation to comply with the law** – in this case, by providing evidence to support an SE application,” said Zeller. “Because the company failed to meet the requirement of the Tobacco Control Act, the FDA’s decision means that, regardless of when the products were manufactured, these four products can no longer be legally imported or sold or distributed through interstate commerce in the United States.”

This type of regulation would require companies to 'meet the requirements' and my comment about ecig vendors vs. Njoy and Blu is that the latter may have the resources to comply where smaller vendors would not. I'm not certain as to what the actual requirements in this case are but assumed it would take some time, effort (lab work?), and money to comply.

 

[Fast and Furious]

Which products were involved? Is there a link to the full story?

The 'link' is in Post Number One.

Tom