Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

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Sun Vaporer

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I posted this in the other thread on this topic, but will post it here as well. Curious if anyone else finds this significant.

The DC Circuit Court of Appeals is actually packed with Judges who were appointed by republicans. I am not a republican myself, but this might be a good thing on this particular issue, as conservative judges tend to not favor expansive regulatory powers for federal agencies.

Of the 14 judges in this circuit, 1 was appointed by Carter, 5 were appointed by Reagan, 2 by GHWB, 3 by Clinton and 3 by GWB. If we assume that the judges appointed by repub presidents lean conservative (not always the case but then the reverse is not always true either), then 10 of 14 are conservative leaning.

I believe that cases are typically heard by a panel of 3 judges who are randomly chosen.

This is obviously not a definitive prediction of outcome. Just another piece of information to add to the mix.

- wolf

You are correct Wolf. I posted a while back the bio's of the three Judge's on the panel in the Appeals Court assigned to this case. All three of them seem very well grounded in the decisions I read of each one of them. It is always so hard to say how a panel is going to take on a certain case. All three were appointed by republicans. I do not know if that really is makes a difference in this case, but one never knows.


Sun
 

woolfe99

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You are correct Wolf. I posted a while back the bio's of the three Judge's on the panel in the Appeals Court assigned to this case. All three of them seem very well grounded in the decisions I read of each one of them. It is always so hard to say how a panel is going to take on a certain case. All three were appointed by republicans. I do not know if that really is makes a difference in this case, but one never knows.


Sun

OK, I hadn't read back through the entire thread see if the issue had already been addressed. I do think there is some reason for optimism based on the backgrounds of the judges here, though my optimism is very cautious and qualified.

The DC circuit is the most prestigious of the of the federal appellate circuits and is often considered a springboard to the SCOTUS. I think judges at that level are less impressed with amicus briefs from prominent organizations and are more influenced by their personal philosophies, biases, ideologies, prediclictions, and opinions regarding statutory interpretation, etc.

So far as I know, these medical organizations cannot present evidence as "experts" in this appeal. That can only be done at the District Court level. As such, they can really only add a legal brief which probably won't say much more than the FDA's brief. The significance of their brief is just in the fact that they are going on record as supporting the FDA's position. While that is not good news, and might influence the panel, as I said, I think judges at this level are less interested a list of organizations who have taken one position or another and more motivated by issues personal to them. I could be wrong here, but that is my best guess.

- wolf
 

woolfe99

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Wolf--I always like to think that the Courts do not work as you say, but who knows and you could be right, but if you are, it might cut both ways as there is Big Pharma and Big Tobb to protect.


Sun

It might be. I doubt that federal court judges are interested in protecting special interest groups, even monied interests. I am not being a pie eyed optimist when I say that. What I mean is that a judge will be influenced by personal ideology, maybe even strongly. However, special interest money, AFAIK, shouldn't be finding its way into their pockets.

My experience with federal court judges, especially at the appellate level, is that they tend to think they are gods. Accordingly, they aren't very impressed by credentials, including the prominence of organizations filing amicus briefs. They have their own ideas about the law, and those ideas may or may not be objective. However, the suspecibility to outside influences tends not to be very high, at least in comparison to say Congress, or government regulatory agencies like the FDA.

So yes, I think it's very good news if this panel turns out to lean conservative in their views, as it suggests that they may not like government regulators. The lower court opinion in this case definately smacked of a conservative lean, which I thought was pretty obvious considering the various remarks made about the FDA in that opinion. In fact, some might say that the opinion was ever so slightly intemperate in its tone, in certain places.

Let's hope we have that same bent in our appellate panel. It's very important, since this injunction is pretty much the entire case as any opinion they hand down will guide the district court to its ultimate conclusion.

- wolf
 

JustJulie

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It is not about "Gloom" Jerry. For me, it is and always will be about not "staying the course" and thinking "everything will be fine". To me that is denial of what we are up against and causes inaction and "going with the flow" IMO.

I remember the days on this Board when the majority screamed at the top of their lungs that "they will never bother to attempt to ban the e-cig" and "they can not ban the hardware" or "it will never happen".

It was only until this case was filed and States started to file legislation that advocacy started. So it is not a question of truth Jerry, rather facing the fact that this is no easy battle we have here.

Sun

Well, I guess you can say a lot of things about me, but I don't think anyone can say that my Pollyannish ways have caused me to go with the flow or to be inactive. ;)

Going into battle, it's important to be realistic, but that doesn't mean that you can't be optimistic. :)
 

Janetda

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This my be OT, but I wasn't sure where to through this in, so I'll post it here.

I think the FDA has shown it's true colors any number of times. They will always side with BP. When they decided to ban a type of vitamine B6, they said, "Although pyridoxamine is a dietary ingredient within the meaning of § 201(ff)(1), FDA determined that pyridoxamine is excluded under § 201(ff)(3) because: (1) pyridoxamine is authorized for investigation as a new drug for which substantial clinical investigations have been conducted and their existence made public..." (FDA Law Blog) The FDA has even gone so far as to tell Diamond Walnut's that they can't promote the health giving aspects of walnuts because pyridoxamine is now a drug and walnuts aren't an approved drug. They did the exact same thing with red yeast rice when statins came out.



What the FDA is saying is that if a drug company wants to market it, then they will clear the way for them. There is no differnce between what is going on in the food suppliment industry than what we are seeing with nicotine. This is what the FDA does.
 

Sun Vaporer

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It might be. I doubt that federal court judges are interested in protecting special interest groups, even monied interests. I am not being a pie eyed optimist when I say that. What I mean is that a judge will be influenced by personal ideology, maybe even strongly. However, special interest money, AFAIK, shouldn't be finding its way into their pockets.

My experience with federal court judges, especially at the appellate level, is that they tend to think they are gods. Accordingly, they aren't very impressed by credentials, including the prominence of organizations filing amicus briefs. They have their own ideas about the law, and those ideas may or may not be objective. However, the suspecibility to outside influences tends not to be very high, at least in comparison to say Congress, or government regulatory agencies like the FDA.

So yes, I think it's very good news if this panel turns out to lean conservative in their views, as it suggests that they may not like government regulators. The lower court opinion in this case definately smacked of a conservative lean, which I thought was pretty obvious considering the various remarks made about the FDA in that opinion. In fact, some might say that the opinion was ever so slightly intemperate in its tone, in certain places.

Let's hope we have that same bent in our appellate panel. It's very important, since this injunction is pretty much the entire case as any opinion they hand down will guide the district court to its ultimate conclusion.

- wolf


Interesting observations about the Court Wolf. Thanks for your original input. I have heard many times that the DC District is indeed THE Federal Court to be appointed to out of all of them. So hearing this again from you only makes sense.

Sun
 

lotus14

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If anyone has the full text of the brief filed by e-cigarette prohibitionist, please post.

And if the Washington Legal Foundation filed a brief (which somebody claimed in a previous posting), please post its text as well (as this is the first I've heard about it).

Nobody should be surprised that ACS, ALA, AHA, ASH and others have joined together to file a brief, as that's the way they've been operating for more than a decade.

What I find unfortunate and irresponsible is that some folks on this forum are predicting gloom and doom defeat before they've even read the motion, before the court has considered it, and before the court has ruled on it.

Bill, you've been around long enough to know this is the 'gloom and doom' thread. ;)

As for "clout" and "power" with the courts, well, the courts are supposed to rule based upon the law, not bowing to "clout" and "power." But since the Washington Legal Foundation is indeed well known in the legal community, I would suggest that they have no less "clout" or "power" than the alphabet soup of "charities" when it comes to presenting to the Court of Appeals.

A doom and gloom attitude is defeatist and unwarranted. In Illinois, we stood toe to toe against a paid lobbyist representing the American Heart Association, the American Lung Association, and the American Cancer Society . . . and we won.

And regardless of the outcome at the Court of Appeals, the case in chief has yet to be heard.

This is far from over.

Yes, it's far from over...a long way to go and much work yet to be done. Gloom and doom pronouncements from people 'in authority' who should know better just makes people think "What's the point in trying?"

Great job in Illinois Julie showing what can be done if people actually do something. Few people will even try something if they believe they have little chance of success.
 

Sun Vaporer

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This my be OT, but I wasn't sure where to through this in, so I'll post it here.

I think the FDA has shown it's true colors any number of times. They will always side with BP. When they decided to ban a type of vitamine B6, they said, "Although pyridoxamine is a dietary ingredient within the meaning of § 201(ff)(1), FDA determined that pyridoxamine is excluded under § 201(ff)(3) because: (1) pyridoxamine is authorized for investigation as a new drug for which substantial clinical investigations have been conducted and their existence made public..." (FDA Law Blog) The FDA has even gone so far as to tell Diamond Walnut's that they can't promote the health giving aspects of walnuts because pyridoxamine is now a drug and walnuts aren't an approved drug. They did the exact same thing with red yeast rice when statins came out.



What the FDA is saying is that if a drug company wants to market it, then they will clear the way for them. There is no differnce between what is going on in the food suppliment industry than what we are seeing with nicotine. This is what the FDA does.

Janetda--have you ever read any of these cases? The FDA spends way to much time on enforcement of "health claims" rather then actually trying to help the Consumer. I did not hear about Diamond Walnuts, but I will take a read for sure.

Sun
 

Sun Vaporer

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I think my point is that they took something that was perfectly legal, not causing any harm to anyone and banned it because a drug company wanted it. That has to be illegal.


I hear what you are saying Janetda--I am looking at it now. There is a lot of writings on it. I will let you know what I think. Again thanks for the post.

Sun
 

Janetda

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Diamond Food Inc. 2/22/10

It's another, I Kid You Not.

Based on claims made on your firm's website, we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease. The following are examples of the claims made on your firm's website under the heading of a web page stating "OMEGA-3s ... Every time you munch a few walnuts, you're doing your body a big favor.":
• "Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses."

• "[O]mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats ... "

• "n treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring neurons."

• "The omega-3s found in fish oil are thought to be responsible for the significantly lower incidence of breast cancer in Japanese women as compared to women in the United States."

Because of these intended uses, your walnut products are drugs within the meaning of section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(B)]. Your walnut products are also new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for the above referenced conditions. Therefore, under section 505(a) of the Act [21 U.S.C. § 355(a)], they may not be legally marketed with the above claims in the United States without an approved new drug application.
 

Sun Vaporer

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Diamond Food Inc. 2/22/10

It's another, I Kid You Not.

Based on claims made on your firm's website, we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease. The following are examples of the claims made on your firm's website under the heading of a web page stating "OMEGA-3s ... Every time you munch a few walnuts, you're doing your body a big favor.":
• "Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses."

• "[O]mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats ... "

• "n treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring neurons."

• "The omega-3s found in fish oil are thought to be responsible for the significantly lower incidence of breast cancer in Japanese women as compared to women in the United States."

Because of these intended uses, your walnut products are drugs within the meaning of section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(B)]. Your walnut products are also new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for the above referenced conditions. Therefore, under section 505(a) of the Act [21 U.S.C. § 355(a)], they may not be legally marketed with the above claims in the United States without an approved new drug application.



Claims were made on their website Janet---Every doctor I know tells me to eat nuts for the reasons stated by Diamond. Again this just points out the fact that there is simply no logic in play here with the FDA.

Sun
 
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kristin

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Because of these intended uses, your walnut products are drugs within the meaning of section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(B)]. Your walnut products are also new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for the above referenced conditions. Therefore, under section 505(a) of the Act [21 U.S.C. § 355(a)], they may not be legally marketed with the above claims in the United States without an approved new drug application.

Un - freaking - believable. :nah:
 

yanks21

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I think my point is that they took something that was perfectly legal, not causing any harm to anyone and banned it because a drug company wanted it. That has to be illegal.

Not to stray too far OT but since Diamond Walnuts was brought up I figured I would bring up Stevia.

Stevia - Wikipedia, the free encyclopedia

Basically Stevia is a natural herbal sweetener that has been used in other countries FOREVER - Japan has been using it for decades as a sweetener. Not only is not bad for you (as sugar substitutes such as Sweet & Low seem to be) some studies actually show health benefits and Diabetes is an epidemic in this country so a product like Stevia is a no-brainer . . .

The wiki page is worth reading if you're interested but for the sake of brevity I will just quote a bit of it:

Political controversy

In 1991, the United States Food and Drug Administration (FDA) labeled stevia as an "unsafe food additive" and restricted its import. The FDA's stated reason was "toxicological information on stevia is inadequate to demonstrate its safety."[53] This ruling was controversial, as stevia proponents pointed out that this designation violated the FDA's own guidelines under which natural substances used prior to 1958, with no reported adverse effects, should be generally recognized as safe (GRAS) as long as the substance was being used in the same way and format as prior to 1958.


Stevia occurs naturally, requiring no patent to produce it. As a consequence, since the import ban in 1991, marketers and consumers of stevia have shared a belief that the FDA acted in response to industry pressure.[27] Arizona congressman Jon Kyl, for example, called the FDA action against stevia "a restraint of trade to benefit the artificial sweetener industry."[54] To protect the complainant, the FDA deleted names in the original complaint in its responses to requests filed under the Freedom of Information Act.[27]
Stevia remained banned until after the 1994 Dietary Supplement Health and Education Act forced the FDA in 1995 to revise its stance to permit stevia to be used as a dietary supplement, although not as a food additive — a position that stevia proponents regard as contradictory because it simultaneously labels stevia as safe and unsafe, depending on how it is sold.[55]

. . .

In December 2008, the FDA gave a "no objection" approval for GRAS status to Truvia (developed by Cargill and The Coca-Cola Company) and PureVia (developed by PepsiCo and the Whole Earth Sweetener Company, a subsidiary of Merisant), both of which use rebaudioside A derived from the Stevia plant.[57]

Isn't it funny that Stevia wasn't approved as a food additive until a large company like Coca-Cola decided they wanted to use it?

If any mod feels this doesn't add to the discussion please feel free to delete. ;)
 
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Sun Vaporer

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Not to stray too far OT but since Diamond Walnuts was brought up I figured I would bring up Stevia.

Stevia - Wikipedia, the free encyclopedia

Basically Stevia is a natural herbal sweetener that has been used in other countries FOREVER - Japan has been using it for decades as a sweetener. Diabetes is an epidemic in this country and a product like Stevia is a no-brainer . . .

The wiki page is worth reading if you're interested but for the sake of brevity I will just quote a bit of it:



Isn't it funny that Stevia wasn't approved as a food additive until a large company like Coca-Cola decided they wanted to use it?

If any mod feels this doesn't add to the discussion please feel free to delete. ;)


Yanks--to the contrary, you advance another good example of the fine work the FDA does.


Sun
 
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