FDA FDA response to lawsuits.

[bigdancehawk]

The only thing reasonably related to tobacco is nicotine. Isn't nicotine grandfathered in? So aside from nicotine, how can anything else be deemed illegal? Is inhaling vick's vaporrub illegal?

Follow the money

A nicotine product is grandfathered if the identical nicotine product was being "commercially marketed" on Feb. 15, 2007. Do you know of any? According to the FSPTCA, altering that product (such as diluting it with PG, VG and/or adding flavors) is "manufacturing" a new tobacco product and requires FDA approval before it can be legally sold.
I'm not sure that Vaporub has much to do with it.

 

[WillyZee]

the FDA has a back-up plan

the judge should do well

 

[YoursTruli]

I already gave my opinion on that but I will give it again.

It's because the tobacco industry lied to everybody for decades, and now there is extraordinary oversight and caution because nobody wants to be "taken" again.

You can't bring a new product or technology to market now and just give word "assurance" that "our stuff is totally safe!" ...... because that's not how things have turned out (not only with cigs but with supplements, drugs, etc.)

(Don't even get me started on "assurances" from corporations and oil companies like BP and the The Deepwater Horizon disaster.......I have a friend who's family member died that day......it still will cost BP less than the cost of providing proper and regular maintenance ..... a life lost is cheaper than actually doing the right and honest thing........)

but the true science is there to support the claims, the FDA is choosing to ignore that science and blatantly lie about the scientific facts.... and actual figures and how far their authority extends and...... throwing hundreds of millions of dollars at junk science research to get results that say what they want the science to say. ...for starters

 

[bigdancehawk]

I agree that People need to pay More Attention. But I Also think that their scrutiny of what is Going On needs to be aimed Higher.

Did Mitch Zeller have the Final say as to what the FDA's Deeming of e-Cigarettes looked like?
If Not, who at the FDA is Ultimately Responsible for FDA Policies.
And does the FDA answer Directly to any Other Government Agency?

I see Mr. Zeller's name in media a Lot when it comes to e-Cigarettes. But the name Califf is seldom mentioned. And the name Burwell is virtually Non-Existent.

The person ultimately responsible is Barack Obama. Next down the ladder is the Secretary of the Department of Health and Human Services, Sylvia Mathews, who reports directly to Obama, who has no training or background in science or medicine and who had has never held a real job outside of government:

 

[JimDrock]

Yet they state

The above found here: Nicotine Replacement Therapy Labels May Change

They seriously cannot have it both ways!!! Holy they are blithering idiots!

Wow, that pretty much blows-up the FDA`s foundational argument of nicotine's (so-called) addictive properties. I guess according to the FDA's revised NRT labeling requirements, nicotine is no-where near as bad as previously believed. That being the case, does that mean the concern for teenagers becoming addicted is unfounded?

It is interesting that the FDA NOW claims that nicotine is the most addictive substance, however, a quick Internet search indicates otherwise. Although I did not do an exhaustive search, the (very) few sites I did visit placed (a certain drug) as number one and Alcohol as number 2......Nicotine number 5.

So since the FDA nows says that nicotine is the most addictive substance, I assume that (the certain drug) must now be concidered the most-super-duper-ultra addictive substance.

Just my .

 

[bigdancehawk]

The person ultimately responsible is Barack Obama. Next down the ladder is the Secretary of the Department of Health and Human Services, Sylvia Mathews, who reports directly to Obama, who has no training or background in science or medicine and who had has never held a real job outside of government:

Edit: You asked about Cardiff, head of the FDA. According to Wikipedia:
"Califf worked very closely with pharmaceutical companies at the Duke clinical trials center "convincing them to do large, expensive, and, for Duke, profitable clinical trials."[10] He was a paid consultant for Merck Sharp & Dohme, Johnson & Johnson, GlaxoSmithKline,AstraZeneca, and Eli Lilly per ProPublica from 2009 to 2013. The largest consulting payment was $87,500 by Johnson & Johnson in 2012, and "most of funds for travel or consulting under $5,000", which has been called "minimal for a physician of his stature".[11] From 2013-2014 he was paid a total of $52,796, the highest amount was $6,450 from Merck Sharp & Dohme, followed by Amgen, F. Hoffmann-La Roche AG, Janssen Pharmaceutica, Daiichi Sankyo, Sanofi-Aventis, Bristol-Myers Squibb and AstraZeneca.[12] He was the Director of Portola Pharmaceuticals, Inc. from July 2012 to January 26, 2015,[11] Advisor of Proventys, Inc., Chairman of the medical advisory board of Regado Biosciences, Inc. and has been member of the medical advisory board since June 2, 2009, and member of the clinical advisory board of Corgentech Inc.[13] Forbes wrote that his close ties to the drug industry were the reason for him not being nominated for the FDA Commissioner position in 2009.[10]"

 

[bigdancehawk]

Wow, that pretty much blows-up the FDA`s foundational argument of nicotine's (so-called) addictive properties. I guess according to the FDA's revised NRT labeling requirements, nicotine is no-where near as bad as previously believed. That being the case, does that mean the concern for teenagers becoming addicted is unfounded?

It is interesting that the FDA NOW claims that nicotine is the most addictive substance, however, a quick Internet search indicates otherwise. Although I did not do an exhaustive search, the (very) few sites I did visit placed ...... as number one and Alcohol as number 2......Nicotine number 5.

So since the FDA nows says that nicotine is the most addictive substance, I assume that ...... must now be concidered the most-super-duper-ultra addictive substance.

Just my .

The FSPTCA is premised on the very specific declaration that nicotine is addictive. It's a congressional finding. The FDA will argue that it can't take a position contrary to a congressional mandate.

 

[JimDrock]

The FSPTCA is premised on the very specific declaration that nicotine is addictive. It's a congressional finding. The FDA will argue that it can't take a position contrary to a congressional mandate.

I don't disagree, however the point being that the FDA claims that Now, in the lawsuit response, that nicotine is "the most addictive substance". However, according to the FDA Web link provided by Robin, The FDA lessened the labeling requirements for NRT, so gum that contains nicotine was then considered safer. Both of these conflicting claims were/are published by the FDA.

 

[bigdancehawk]

I don't disagree, however the point being that the FDA claims that Now, in the lawsuit response, that nicotine is "the most addictive substance". However, according to the FDA Web link provided by Robin, The FDA lessened the labeling requirements for NRT, so gum that contains nicotine was then considered safer. Both of these conflicting claims were/are published by the FDA.

Surely you're not suggesting that when it regulates a drug product the FDA can't take a position inconsistent with the position it takes when it regulates a tobacco product. I'm shocked--shocked I say!
Approved drug products: good
Unapproved tobacco products: bad
Keep that foremost in your mind and you'll begin to understand how this works.

 

[jwbnyc]

I believe it started with mandatory bicycle helmets.
But it may have started way before that.

I don't know how we survived without those.

 

[jwbnyc]

Seat belts.

My father used to install seatbelts in his cars before it became a matter of law.

 

[Racehorse]

Edit: You asked about Cardiff, head of the FDA. According to Wikipedia:
"Califf worked very closely with pharmaceutical companies at the Duke clinical trials center "convincing them to do large, expensive, and, for Duke, profitable clinical trials."[10] He was a paid consultant for Merck Sharp & Dohme, Johnson & Johnson, GlaxoSmithKline,AstraZeneca, and Eli Lilly per ProPublica from 2009 to 2013. The largest consulting payment was $87,500 by Johnson & Johnson in 2012, and "most of funds for travel or consulting under $5,000", which has been called "minimal for a physician of his stature".[11] From 2013-2014 he was paid a total of $52,796, the highest amount was $6,450 from Merck Sharp & Dohme, followed by Amgen, F. Hoffmann-La Roche AG, Janssen Pharmaceutica, Daiichi Sankyo, Sanofi-Aventis, Bristol-Myers Squibb and AstraZeneca.[12] He was the Director of Portola Pharmaceuticals, Inc. from July 2012 to January 26, 2015,[11] Advisor of Proventys, Inc., Chairman of the medical advisory board of Regado Biosciences, Inc. and has been member of the medical advisory board since June 2, 2009, and member of the clinical advisory board of Corgentech Inc.[13] Forbes wrote that his close ties to the drug industry were the reason for him not being nominated for the FDA Commissioner position in 2009.[10]"

Why would the head of the FDA be a person WITHOUT any experience in pharma, clinical trials, or consulting?

I'm curious what kind of back ground is acceptable?


I really am curious what kinds of background you guys think somebody who can become head of the US FDA should have........these are highly educated M.Ds. with quite a lot of immersion in the fields of pharma, clinical trials, research, studies, etc. Of course they are highly paid.....I don't begrudge them their consulting fees. When you pay for that much education, and go to school for 12+ years, then you command consulting fees in the 2 and 3 figure areas.

CEOs of famous companies, and politicians do too. That is what happens when you reach the upper most level of your profession. (2016 is going to be a banner year for the political consulting industry. Through early December, candidates from both parties and their affiliated super PACs have spent more than $160 million on consulting services.)

If your company hires anyone to do executive coaching, it costs about $725 an hour. $500 an hour is considered normal. According to Forbes, "A partner at a small management or IT consulting firm (maximum sales: $10 million) charges $294 per hour on average". Coastal and urban-based consultants can command about 25% more than that. For a large over $10million firm, of course the consultants are going to be paid alot more.

Marshall Goldsmith a well-known Ph.D. mathematician receives $100,000 and up per coaching assignment for a Fortune 500 CEO...McKinsey, Bain and BCG and those kind of firms get much (MUCH) more.

this is normal practice when people are at high educational and experience levels...throughout the corporate, medical, scientific, IT and mathematical world..

 

[Racehorse]

but the true science is there to support the claims, the FDA is choosing to ignore that science and blatantly lie about the scientific facts.... and actual figures and how far their authority extends and...... throwing hundreds of millions of dollars at junk science research to get results that say what they want the science to say. ...for starters

So despite that "the e-cigarette market, it is dominated by the major tobacco companies", you think the FDA should just trust them and say vaping is what........99% safe?

And here all along I thought, according to many on the forum, that the FDA was going to "give BT" all of the vaping world on a silver platter.

But it sure sounds to me like they are going to be hard taskmasters on them, in actuality.

 

[Racehorse]

Approved drug products: good
Unapproved tobacco products: bad.

How long have NRT patches been on the market? How many studies done on them? About 3 decades.

Vaping has been around for less than 10 years. Can't really compare. At least, not yet.

I assume the FDA knows a lot more about nic patches than it does about vaping? That is how they have come around to changing the sheet on it.

This is all a process, as I have pointed out. I am not happy about it, but I don't actually take it "personally". I am trying to follow and understand the process, and with an open mind, not an angry, cynical pre-conceived one.

So do you agree that the FDA is going to hand over vaping to BT lock stock and barrel, based on what they have said so far? I sure don't see it.

 

[Semiretired]

So do you agree that the FDA is going to hand over vaping to BT lock stock and barrel, based on what they have said so far? I sure don't see it.

They are not really handing it over to BT, just making it cost prohibitive for smaller businesses, which does limit who can enter the market.

 

[retired1]

As a reminder: Strictly on-topic please

Lot of side discussions trying to creep into this. Let's keep it on topic please.

 

[Robino1]

Wow, that pretty much blows-up the FDA`s foundational argument of nicotine's (so-called) addictive properties. I guess according to the FDA's revised NRT labeling requirements, nicotine is no-where near as bad as previously believed. That being the case, does that mean the concern for teenagers becoming addicted is unfounded?

It is interesting that the FDA NOW claims that nicotine is the most addictive substance, however, a quick Internet search indicates otherwise. Although I did not do an exhaustive search, the (very) few sites I did visit placed (a certain drug) as number one and Alcohol as number 2......Nicotine number 5.

So since the FDA nows says that nicotine is the most addictive substance, I assume that (the certain drug) must now be concidered the most-super-duper-ultra addictive substance.

Just my .

Exactly. They cannot have it both ways. They state that in Pharmaceutical drugs, nicotine is not addictive and not harmful yet turn around and in their response the FDA state that it is one of The Most Addictive and Harmful substances.... <Mind blown>

Edit: You asked about Cardiff, head of the FDA. According to Wikipedia:
"Califf worked very closely with pharmaceutical companies at the Duke clinical trials center "convincing them to do large, expensive, and, for Duke, profitable clinical trials."[10] He was a paid consultant for Merck Sharp & Dohme, Johnson & Johnson, GlaxoSmithKline,AstraZeneca, and Eli Lilly per ProPublica from 2009 to 2013. The largest consulting payment was $87,500 by Johnson & Johnson in 2012, and "most of funds for travel or consulting under $5,000", which has been called "minimal for a physician of his stature".[11] From 2013-2014 he was paid a total of $52,796, the highest amount was $6,450 from Merck Sharp & Dohme, followed by Amgen, F. Hoffmann-La Roche AG, Janssen Pharmaceutica, Daiichi Sankyo, Sanofi-Aventis, Bristol-Myers Squibb and AstraZeneca.[12] He was the Director of Portola Pharmaceuticals, Inc. from July 2012 to January 26, 2015,[11] Advisor of Proventys, Inc., Chairman of the medical advisory board of Regado Biosciences, Inc. and has been member of the medical advisory board since June 2, 2009, and member of the clinical advisory board of Corgentech Inc.[13] Forbes wrote that his close ties to the drug industry were the reason for him not being nominated for the FDA Commissioner position in 2009.[10]"

I wonder if any of the lawsuits will bring up the conflict of interest issue. Especially in light of the way the FDA treats nicotine in pharma drugs and nicotine in e-cigs.

I don't have a huge problem with people of the scientific pharma background working for the FDA. I do have a problem with them being head of the FDA. I believe that an unbiased person should be the head of the FDA.

 

[Robino1]

I really hope that the lawyers working for us have noticed the double standard that the FDA's position is on nicotine in ecigs vs nicotine in Pharma products.

 

[pennysmalls]

How long have NRT patches been on the market? How many studies done on them? About 3 decades.

Vaping has been around for less than 10 years. Can't really compare. At least, not yet.

I assume the FDA knows a lot more about nic patches than it does about vaping? That is how they have come around to changing the sheet on it.

snipped

It's sad because, in essence, that would be exactly like saying food itself delivered via feeding tube may not be as safe as oral delivery. As far as nicotine goes I don't think any more needs to be done as far as studying it goes, no matter how it's delivered. It's crazy that the FDA is trying to get away with this non sense in regards to nicotine.

 

[Endor]

Where the NRT angle makes sense is in regards to those nicotine inhalers. Similar delivery mechanism. I don't think those are OTC, however...