FDA to send Section 918 report to Congress on Monday (will include e-cigs)

[Elnroth]

You know if I missed the deadline for three reports at my job, well it wouldn't be my job anymore.

 

[Bill Godshall]

Here's an e-mail the FDA sent to a news reporter who inquired about the agency's report on Section 918 (whose deadline was today).

From: Haliski, Jennifer [mailto:Jennifer.Haliski@fda.hhs.gov]
Sent: Monday, April 01, 2013 12:38 PM
To:
Subject:

FDA is missing the other statutory deadlines related to the three reports to Congress and the two items on harmful and potentially harmful constituents. Below are the two statements from the Agency on those issues:

FDA statement related to missing April 01, 2013 Report to Congress deadlines

The Family Smoking Prevention and tobacco Control Act (Tobacco Control Act) requires the Secretary of the Department of Health and Human Services to submit to Congress three reports dealing with specific tobacco-related issues by April 1, 2013. These reports are near completion and will be submitted to Congress in the near future. The subjects of the required reports are:

Examining how to best regulate, promote, and encourage the development of innovative products and treatments to reduce or eliminate tobacco dependence and harm (section 918(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the TCA);
Reporting on the implementation of the Tobacco Control Act (TCA section 106(a)); and
Reporting on U.S. tobacco product exports that do not conform to tobacco product standards (section 801(p)(1) of the FD&C Act, as amended by the TCA).

FDA Statement on HPHC Statutory Deadlines

The Family Smoking Prevention and Tobacco Control Act gives the FDA an extraordinary opportunity to improve the health of all Americans, whether they use tobacco or not. One of the goals of the law is to improve consumer understanding of tobacco products and their related harms, as tobacco use continues to be the leading cause of preventable death and disease in the United States.

Part of the law requires the FDA to publicly display information about harmful and potentially harmful constituents (HPHCs), chemicals in tobacco products and tobacco smoke that cause harm, or could cause harm, to users and non-users. The FDA is required by law to provide this information to the public, including the amount of each chemical present in specific brands and sub-brands of tobacco products, in a way that is understandable and not misleading by April 1, 2013.

The FDA is currently not ready to make this information available by the upcoming deadline, but will do so once the Agency is confident that the information is accurate, understandable and not misleading to the public. Currently, the Agency is still evaluating the data it has received from manufacturers, including verifying its accuracy. In addition, FDA is planning to conduct scientific studies to assess consumer understanding of how the Agency presents information about HPHCs. Upon completion of these important activities, FDA intends to publish the HPHC information so that consumers can make more informed decisions about tobacco products.

Section 915 of the Federal Food, Drug and Cosmetic Act requires the FDA to issue regulations by April 1, 2013 requiring the testing and reporting of tobacco product constituents, ingredients, and additives that the FDA determines should be tested to protect the public health. The FDA intends to follow notice and comment rulemaking procedures and issue a proposed rule. FDA will publish a proposed date in the Unified Agenda, which semi-annually lists all of the Agency’s projected publication dates.

 

[junkman]

Here's an e-mail the FDA sent to a news reporter who inquired about the agency's report on Section 918 (whose deadline was today).

From: Haliski, Jennifer [mailto:Jennifer.Haliski@fda.hhs.gov]
Sent: Monday, April 01, 2013 12:38 PM
To:
Subject:

FDA is missing the other statutory deadlines related to the three reports to Congress and the two items on harmful and potentially harmful constituents. Below are the two statements from the Agency on those issues:

FDA statement related to missing April 01, 2013 Report to Congress deadlines

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires the Secretary of the Department of Health and Human Services to submit to Congress three reports dealing with specific tobacco-related issues by April 1, 2013. These reports are near completion and will be submitted to Congress in the near future. The subjects of the required reports are:

Examining how to best regulate, promote, and encourage the development of innovative products and treatments to reduce or eliminate tobacco dependence and harm (section 918(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the TCA);
Reporting on the implementation of the Tobacco Control Act (TCA section 106(a)); and
Reporting on U.S. tobacco product exports that do not conform to tobacco product standards (section 801(p)(1) of the FD&C Act, as amended by the TCA).

FDA Statement on HPHC Statutory Deadlines

The Family Smoking Prevention and Tobacco Control Act gives the FDA an extraordinary opportunity to improve the health of all Americans, whether they use tobacco or not. One of the goals of the law is to improve consumer understanding of tobacco products and their related harms, as tobacco use continues to be the leading cause of preventable death and disease in the United States.

Part of the law requires the FDA to publicly display information about harmful and potentially harmful constituents (HPHCs), chemicals in tobacco products and tobacco smoke that cause harm, or could cause harm, to users and non-users. The FDA is required by law to provide this information to the public, including the amount of each chemical present in specific brands and sub-brands of tobacco products, in a way that is understandable and not misleading by April 1, 2013.

The FDA is currently not ready to make this information available by the upcoming deadline, but will do so once the Agency is confident that the information is accurate, understandable and not misleading to the public. Currently, the Agency is still evaluating the data it has received from manufacturers, including verifying its accuracy. In addition, FDA is planning to conduct scientific studies to assess consumer understanding of how the Agency presents information about HPHCs. Upon completion of these important activities, FDA intends to publish the HPHC information so that consumers can make more informed decisions about tobacco products.

Section 915 of the Federal Food, Drug and Cosmetic Act requires the FDA to issue regulations by April 1, 2013 requiring the testing and reporting of tobacco product constituents, ingredients, and additives that the FDA determines should be tested to protect the public health. The FDA intends to follow notice and comment rulemaking procedures and issue a proposed rule. FDA will publish a proposed date in the Unified Agenda, which semi-annually lists all of the Agency’s projected publication dates.

I wonder if this requirement of listing HPHCs is a double edged sword to vaping. On the one hand, if they were to provide this information for e-liquid, I suspect the conclusion would be indisputable about relative safety - on the other hand, the requirement for listing on brand/sub-brand basis implies significant costs for each liquid, and likely each flavor offered. This could wipe out the e-liquid business by itself.

I guess that major players could afford a couple flavors or could have unflavored nic bases tested and consumer could add their own flavors. In any case, if this is required of e-liquid, it would mean signficant consolidation of sources of supply I would guess.

 

[Horselady154]

The FDA provides harm. I say let's abolish them.

A good first step in the many federal agencies that should be abolished.

 

[Fiamma]

The FDA provides harm. I say let's abolish them.

A good first step in the many federal agencies that should be abolished.

Hear Hear !!

 

[DC2]

This is all so freaking fascinating...

But what I'm getting out of all of this is that "we" vapers have upset the apple cart.
And the FDA, due to our incredible showing of over 5000 official comments, is now in back-to-the-drawing-board mode.

Those that think the FDA doesn't care about what we have to say perhaps should reconsider the impact our actions might be having.

 

[ElectricalSocket]

With respect, I don't believe BT will gain much from selling an inferior product. A quote from wikipedia: "Smoking rates in the United States have dropped by half from 1965 to 2006 falling from 42% to 20.8% of adults.". More people are quitting or just not starting. The ANTZ campain to demonize tobacco has worked wonderfully. Based on the idea that cig-a-likes don't work and smokers will go back to smoking, they are STILL losing money. Look at these numbers... Caffeine. 90% of the worlds population uses caffeine in some form. What if they are able to prove that nicotine is no worse than caffeine? With the money BT has, what if they started selling a superior e-cig that is better than anything we have now? What if their customer base jumped from 20% to 50% of the adult population? Or even 80%? You don't think that would benefit them?

This is the information age. More people look up reviews before they buy products. How many people are here right now because they started with a Blu type cig and then looked up better alternatives on the net? Yes, they are making money from first time buyers, but as time goes on and e-cigs become more popular, the word will spread that cig-a-likes are junk and that there are better options. It's already started. Just look up "Blu e-cig reviews" or "best e-cig". Even if an article is only reviews of different cigalikes, the comments section has vapers like us giving everyone a heads-up about bigger and more effective models.

Selling an inferior product is a business model destined to fail. They could make BILLIONS more by proving nicotine is just as "safe" as redbull and by selling a product that is actually satisfying to current smokers. Of course there will also be many new vapers who never smoked, and this is something that scares the ANTZ, but they need to see that they're being used by BP to keep people sick and dying. They need to stop looking at e-cigs as ruining all the progress they have made, and instead think they have helped push people towards a safer product. As long as they don't ban mods, we can let them stroke their egos and think they saved all the children. Hahaha.

My thoughts are a little jumbled right now, but I hope that makes a little sense.

 

[DC2]

It makes a lot of sense... a LOT of sense.

 

[ElectricalSocket]

100% agree. It's very easy to generalize and think the FDA as a whole is evil, or BP, or BT. We have to step back and realize there are always good and bad people in an organization, it's never as black & white as 'they're all evil scumbags'. I think we absolutely can make a difference.

I know that seems like a naive statement to some, but consider this: Didn't a good judge shut down the FDA last time? If we generalize and think every person in a group is bad or against our best interest, how will we ever gain support from those who would side with us?

Just look at all the whistleblowers who have risked their lives by speaking out against powerful organizations and institutions. Many have been suicided. We have to always remember that there are good souls in every group of people. We have to band together. There is strength in numbers, and there are more of us than there are of them. "Them" being sociopaths in powerful positions, and "people" who put money before human life. Yes WE CAN! LOL

 

[ElectricalSocket]

To put my position a different way:

I have a feeling BT would PREFER their customers live long and healthy lives. They'll make a lot more $$$ if their customers live to be 80+ instead of dying from cancer before 60. Only BP profits from the chronic illness epidemic we are facing.

BT needs to see the potential and fight the FDA and BP. Then they need to start making top-quality clearomizers with the best materials, sterile cotton wicks, and adjustable juice flow. I would pay at most $20/week for a new cotton wick head that won't burn a cheap silicone grommett and is 100% sterile. They need to get on the ball, they have some $$$ to make.

If BP & BT are actually controlled by the same people though (and I believe they very well could be), then the whole 'BT vs BP' point is moot. Oh well, just thinking out loud!

 

[Racehorse]

Selling an inferior product is a business model destined to fail.

In Corporate america, failure is rewarded. Look at CEOs from worldcom, etc. They take their golden parachute after either failing or picking the bones clean like a vulture, then move on to another start-up or company, as CEOs again.....then rinse and repeat.

That's how you end up retiring early into the best gated communities, with a coupla "properties" in the islands......

 

[Horselady154]

100% agree. It's very easy to generalize and think the FDA as a whole is evil, or BP, or BT. We have to step back and realize there are always good and bad people in an organization, it's never as black & white as 'they're all evil scumbags'. I think we absolutely can make a difference.

I know that seems like a naive statement to some, but consider this: Didn't a good judge shut down the FDA last time? If we generalize and think every person in a group is bad or against our best interest, how will we ever gain support from those who would side with us?

Just look at all the whistleblowers who have risked their lives by speaking out against powerful organizations and institutions. Many have been suicided. We have to always remember that there are good souls in every group of people. We have to band together. There is strength in numbers, and there are more of us than there are of them. "Them" being sociopaths in powerful positions, and "people" who put money before human life. Yes WE CAN! LOL

The difference is that when you have those "bad people" infused in government, they are much more difficult to get rid of. They aren't like a company that you can choose to no longer do business with or if it's bad enough, sue. The government is that body that makes the laws and decides who needs to follow them.

 

[Horselady154]

In Corporate america, failure is rewarded. Look at CEOs from worldcom, etc. They take their golden parachute after either failing or picking the bones clean like a vulture, then move on to another start-up or company, as CEOs again.....then rinse and repeat.

That's how you end up retiring early into the best gated communities, with a coupla "properties" in the islands......

No, that is only true in that portion of corporate America who have been given special favors by government. In real life there is no too big to fail and failure is not rewarded with big windfalls. Companies who fail go belly-up and their assets are bought by the highest bidder, who will then, hopefully, put them to a better use. That is how it's supposed to work. But, if a corrupt government steps in, all bets are off.

It is government that rewards failure. Not the private market.

 

[ElectricalSocket]

In Corporate america, failure is rewarded. Look at CEOs from worldcom, etc. They take their golden parachute after either failing or picking the bones clean like a vulture, then move on to another start-up or company, as CEOs again.....then rinse and repeat.

That's how you end up retiring early into the best gated communities, with a coupla "properties" in the islands......

Bernard Ebbers is in federal prison for the rest of his life, unless he lives past 87. I understand where you're coming from though. What you're talking about though involves the gov, banking, and failed company. Usually all interconnected by the same people. Like the banks for instance. "Too big to fail" really means "we control the money, you aren't touching the hand that feeds you".

 

[ElectricalSocket]

I know what you mean. I've just come to realize that it's really not accurate to paint an entire group with a broad brush. The information I have learned over the past 7 years makes it's very easy to think: all judges are corrupt, all police are thugs, all politicians are evil, all alphabet agencies are evil, the entire medical industry is evil, etc etc. It's just good for me to step back sometimes and realize that these generalizations are not always 100% true. Not every CIA agent smuggles dope into the country, for instance.

 

[DaveP]

The FDA has been strangely silent over the technical aspects of vaping. Has there been an actual published test conducted since 2009? You'd have to think that any derogatory medical analysis would be plastered all over the media. For that reason, I really don't think they have any ammunition to use in declaring ecigs a hazard to health. Yes, there's nicotine, but we read that nic is on a par with caffeine for medical harm. Coffee is said to be a beneficial and benign stimulant in most studies. I suspect that the medical value of nicotine, especially in the elderly, is a plus for those who use it.

Sole use of nicotine is a medically proven stop smoking chemical aid. They just don't like the idea of vapers "looking" like they are still smoking.

 

[Elnroth]

This is all so freaking fascinating...

But what I'm getting out of all of this is that "we" vapers have upset the apple cart.
And the FDA, due to our incredible showing of over 5000 official comments, is now in back-to-the-drawing-board mode.

Those that think the FDA doesn't care about what we have to say perhaps should reconsider the impact our actions might be having.

As pleasant as it would be for the FDA to actually care about what we have to say, I'm still skeptical. The delay could be a result of "we" vapers pushing so much science and research through their official channels, and our show of public force against the direction the were leaning towards, that a majority of the data in the report goes against their claims I'm the report.

How can you submit a report where your data contradicts your statements?

 

[tommy2bad]

As pleasant as it would be for the FDA to actually care about what we have to say, I'm still skeptical. The delay could be a result of "we" vapers pushing so much science and research through their official channels, and our show of public force against the direction the were leaning towards, that a majority of the data in the report goes against their claims I'm the report.

How can you submit a report where your data contradicts your statements?

Depends on who your reporting to. Say it's a report to your professor, well he or she will read it and scour the data to check your conclusions.
Now if otoh it to some political type , what you do is bury the data in a 20 page tightly typed 'report' and stick your conclusions in a big typeface cover letter. The only bit they will read is the conclusion and recommendation. After all thats what your payed for.

 

[Vapor Vinny]

When will American citizens realize that our federal government is nothing but an mafia family that will shake down anyone (or industry) that begins to make a profit?

You folks are wasting your time looking at research and/or health effects. That's not even worth debating. Massive taxes on ecig sales are coming. MASSIVE TAXES!!!. Deal with it. The mafia is not going to let ecigs cut into tobacco sales because the mafia makes more off of tobacco sales than the tobacco companies.

Keep voting "progressives" into office and you're going to keep getting progressive tax policies.

 

[Elnroth]

Depends on who your reporting to. Say it's a report to your professor, well he or she will read it and scour the data to check your conclusions.
Now if otoh it to some political type , what you do is bury the data in a 20 page tightly typed 'report' and stick your conclusions in a big typeface cover letter. The only bit they will read is the conclusion and recommendation. After all thats what your payed for.

This is true, but with legislators' interest in their public image, there is a good chance they will look at the public comment section. Maybe someone with with more experience/knowledge with this process can give us a better idea how much the comment matters when congress looks at the report.