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 Mr.Al
Alphabet soup
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 The FDA Proving themselves to be terrorists fighting against the American People AGAIN 
#10331765 - 05/13/09 10:49 AM (14 years, 11 months ago) |
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The Food and Drug Administration slapped General Mills Inc. with a warning over its Cheerios cereal, saying the box's claims about heart benefits contain "serious violations" of federal law.
In a May 5 warning letter sent to the company and posted on the FDA's Web site Tuesday, the agency said statements that the product is "clinically proven to help lower cholesterol" make the product a drug under federal law.
[cheerios and FDA and heart claim]
More
* FDA warning letter to General Mills
Stephen Sundlof, the director of the FDA's food-safety center, said the agency has noticed a tendency by food companies to cross the line into the drug category by making specific health claims on packaging.
He said the FDA is ready to send out more warning letters if it finds more violators, although it has "no specific campaign" to go after food manufacturers.
General Mills spokesman Tom Forsythe said the Cheerios box's message saying the cereal can "lower your cholesterol 4% in six weeks" has been used for more than two years. The box cites a clinical study involving Cheerios as part of a diet low in saturated fat and cholesterol.
Mr. Forsythe said the broader claims on the box about heart health have been permitted by the FDA for 12 years. "The clinical study supporting Cheerios' cholesterol-lowering benefit is very strong," he said.
The FDA said such specific cholesterol-lowering claims can be made only for drugs, and it suggested that if General Mills wants to keep the box labeling as is, it should file a new-drug application for Cheerios.
Mr. Forsythe said the company would work with the agency to reach a "resolution" on the Cheerios labeling.
"We try to make a bright line here between what can be said about a drug and what can be said about a food," said Dr. Sundlof. He said a more general claim about reduction in heart-disease risk from eating whole-grain foods may be permissible as long as specific language is used.
The FDA also took issue with a company-sponsored Web site mentioned on the Cheerios box. The Web site discusses the benefits of eating whole grains, but the FDA said some of the health claims about reducing cancer and heart-disease risk don't comply with agency rules.
The FDA said General Mills must "promptly" correct the violations outlined in the letter or the agency could take enforcement action, such as seizing products.
Dr. Sundlof said the FDA's review of Cheerios was prompted by a September 2008 letter from the National Consumers League that expressed concerns about the labeling on Cheerios.
The FDA isn't the only Washington agency in the Obama administration taking a close look at food makers' health claims. Last month the Federal Trade Commission settled a complaint with Kellogg Co. involving claims that its Frosted Mini-Wheats cereal was clinically shown to improve children's attentiveness by nearly 20%.
FTC Chairman Jon Leibowitz said the commission would start paying more attention to national advertisers.
The FDA is showing signs of taking a more aggressive stance toward the companies it regulates under acting Commissioner Joshua Sharfstein, who is slated to become principal deputy commissioner once President Barack Obama's nominee for commissioner, Margaret Hamburg, is confirmed.
Dr. Sharfstein wrote a letter to lawmakers released this week saying he wants to review the agency's approval in the final days of the Bush administration of a knee device. The device was cleared over the objections of several scientists and managers at the agency.
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MrBump
Third prize is you're fired
Registered: 10/01/02
Posts: 4,263
Loc: Denver, Colorado
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 Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: Mr.Al]
#10333881 - 05/13/09 06:11 PM (14 years, 11 months ago) |
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Why can't they just put an * on the box that states "The cholostorol lowering statements made on the packaging have not been evaluated by the FDA.
This bland, tasteless breakfast food is not intended to diagnose, treat, cure, or prevent any diseases." like they do on all these so-called dietary supplements?
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If it weren't for the bloody corpses, I wouldn't have any corpses at all.
There are two ways to get to the top of an oak tree: start climbing or sit on an acorn.
Are you a carrot, an egg, or a coffee bean?
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Redstorm
Prince of Bugs
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: MrBump]
#10333926 - 05/13/09 06:19 PM (14 years, 11 months ago) |
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An alternative take.
Quote:
Defending Cheerios, Cereal of Liberty
By dan.mitchell
Created 05/13/2009 - 1:06pm
An FDA action has conservatives crying over spilled milk.
Daily Bread [1]
Disputes over food-label claims are always political. But the current, insane iteration of the American right has walked several steps past the crazy line with its collective reaction to the Food and Drug Administration's demand that General Mills [2] (GIS) tone down its health claims for Cheerios [3].
"It's fairly obvious to me why the Obama administration is going after Cheerios over possible deceptive advertising," says the Deadenders blog [4]. "Babies love them more then him."
"This is the kind of irritating, intrusive nonsense that makes people weary of their government and every smarmy bureaucratic microbe in it," writes David Crocker of the Behind Blue Lines blog [5].
The FDA wants General Mills to reel back its claim that Cheerios can "lower your cholesterol 4 percent in 6 weeks." Such a claim is not backed up by science, according to a letter sent to the company by the FDA [6]. The agency says that General Mills is making claims for its cereal that more properly, and according to federal law, should apply only to drugs designed to cure disease. The claims amount to a "serious violation" of laws governing label claims, according to the letter.
That's true, of course. But it hasn't stopped critics from characterizing the situation as President Obama yet again attacking a venerable American institution. Never mind that Obama almost certainly had no idea that his FDA was planning to go after Cheerios.
Food seems to be a common theme among crazy conservatives. For them, wholesome, "American" foods are a-OK. Eurocommie foods are right out. "Washington raised ciggie taxes to pay for SCHIP expansion and are [sic] gearing up to raise soda taxe [7]s [7] to pay for Obamacare," writes the reliably nutty Michelle Malkin [8]. "No vice is safe from the health police. Dijon mustard and arugula exempted, of course."
"So I guess now the Communist-in-Chief will declare a War on Cereal," rants Ed Anger of the Weekly World News [9], proving the increasing irrelevance of old-school parody. You can't tell it from the real thing.
Even in generally saner conservative quarters, marketing Cheerios as medicine is being defended as a matter of liberty. According to David Theroux [10], stopping General Mills from making questionable health claims is just another of the Obama administration's " 'progressive' (i.e., authoritarian) absurdities."
Theroux [11] is the founder and head of the Independent Institute, a libertarian-leaning think tank that opposes the "wars" on terror and drugs and is skeptical on global warming.
The Institute's mission is "to transcend the all-too-common politicization and superficiality of public policy research and debate," according to its Web site [12]. "The Institute’s program is pursued to rigorous standards without regard to any political or social biases."
How about starting with not equating progressive and authoritarian? From there, we can talk about how best to regulate label claims. Would corporate freedom be similarly compromised if, say, Anheuser-Busch InBev [13] started marketing Bud Light as "learning juice," a la Homer Simpson [14]? Or if Kraft [15]'s Nabisco started claiming that Oreos bestow the power of flight?
Note, by the way that none of these critics actually addresses the substance of the FDA's argument.
Admittedly, it would have helped if the FDA's letter had been a bit less strident. "Enforcement action" the agency wrote, "may include seizure of violative products." That's the kind of thing that's bound to startle not only the wingnuts but all of us.
image/jpeg icon
TBM_090513_cheerios.jpg [16]
dan.mitchell [17]
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© 2008-2009 Washington Post.Newsweek Interactive • All rights reserved.
Source URL: http://www.thebigmoney.com/blogs/daily-bread/2009/05/13/defending-cheerios-cereal-liberty
Links:
[1] http://www.thebigmoney.com/blogs/daily-bread
[2] http://www.thebigmoney.com/search/quotemedia/gis
[3] http://www.bloomberg.com/apps/news?pid=20601087&sid=akLaZ4Zwx6g0&refer=home
[4] http://deadenders.wordpress.com/2009/05/13/obama-extorts-cheerios/
[5] http://www.behindbluelines.com/2009/05/13/now-theyre-picking-on-cheerios/
[6] http://www.fda.gov/foi/warning_letters/s7188c.htm
[7] http://www.thebigmoney.com/blogs/daily-bread/2009/05/12/should-we-tax-sugary-drinks
[8] http://michellemalkin.com/2009/05/12/first-they-came-for-the-cheerios/
[9] http://weeklyworldnews.com/opinion/ed-anger/8204/ed-anger-says-hands-off-my-cheerios/
[10] http://www.independent.org/blog/?p=2154
[11] http://www.independent.org/aboutus/person_detail.asp?id=531
[12] http://www.independent.org/aboutus/
[13] http://www.thebigmoney.com/search/quotemedia/abi
[14] http://wordlust.blogspot.com/2005/11/learning-juice.html
[15] http://www.thebigmoney.com/search/quotemedia/kft
[16] http://www.thebigmoney.com/sites/default/files/TBM_090513_cheerios.jpg
[17] http://www.thebigmoney.com/users/danmitchell
http://www.thebigmoney.com/blogs/daily-bread/2009/05/13/defending-cheerios-cereal-liberty?page=full
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 Prisoner#1
Even Dumber ThanAdvertized!
Registered: 01/22/03
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Loc: Pvt. Pubfag NutSuck
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: Redstorm]
#10334197 - 05/13/09 07:15 PM (14 years, 11 months ago) |
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Quote:
Redstorm said:
An alternative take.
Quote:
Defending Cheerios, Cereal of Liberty
The FDA wants General Mills to reel back its claim that Cheerios can "lower your cholesterol 4 percent in 6 weeks." Such a claim is not backed up by science
there's a statement on the front and back of the box that states
"a study showed 2 11/2 cup servings daily for 6 weeks reduced
bad cholesterol about 4% as part of a diet low in saturated fat
and cholesterol", I'm looking at the box right now, I see
nothing false or grossly misleading in that
why'd they approve the heart/cholesterol drugs, Vytorin and
Zetia again? they didnt work, not risk reduction, no reduced
cholesterol, nothing... out of 500 studies only one cast a
positive light on the drug so the FDA approved it and here they
are cracing down on a breakfast cereal... fuck a buncha
uninformed, uneducated, alternative views
http://www.newser.com/story/36414/scientists-still-question-popular-drugs-zetia-vytorin.html
http://www.newser.com/story/22986/2-top-cholesterol-drugs-vytorin-and-zetia-dont-work.html
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MrBump
Third prize is you're fired
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Posts: 4,263
Loc: Denver, Colorado
Last seen: 4 years, 9 months
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: Prisoner#1]
#10334786 - 05/13/09 09:05 PM (14 years, 11 months ago) |
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looks like the FDA did the same thing to cherries back in 2006:
In a warning letter to Friske Orchards of Ellsworth, MI, the FDA recites the following information contained on this orchard’s website:38
“Tart cherries may reduce the risk of colon cancer because of the anthocyanins and cyanidin contained in the cherry.”
The FDA goes on to say in its warning letter:
“These claims cause your product to be a drug as defined in section 201(g) . . . Because this product is not generally recognized as safe and effective when used as labeled, it is also defined as a new drug in section 201(p) . . . Under section 505 of the Act (21 USC 355), a new drug may not be legally marketed in the United States without an approved New Drug Application . . .”
link
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If it weren't for the bloody corpses, I wouldn't have any corpses at all.
There are two ways to get to the top of an oak tree: start climbing or sit on an acorn.
Are you a carrot, an egg, or a coffee bean?
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Prisoner#1
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: MrBump]
#10334889 - 05/13/09 09:33 PM (14 years, 11 months ago) |
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wow, so when used as directed cherries and cheerios are a dangerous drug
if I owned these general mills I'd file suit and demand proof that
making these claims makes them a drug and unsafe.
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MrBump
Third prize is you're fired
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Last seen: 4 years, 9 months
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: Prisoner#1]
#10335056 - 05/13/09 10:04 PM (14 years, 11 months ago) |
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according to an article on yahoo, The FDA's quibble is not about whether Cheerios cereal is good for you but over "how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website," said General Mills.
now, we've all seen those pharmaceutical commercials on tee vee where some woman is running through a rolling field of wheat under a deep purple sky while a voice over lists a multitude of side effects, that leave us asking "wtf exactly does this drug do, again?"
however, simply stating on the side of a box that a few studies showed some positive effects on cholesterol is irresponsible marketing?
apparently the FDA thinks good health can only come from a pill.
--------------------
If it weren't for the bloody corpses, I wouldn't have any corpses at all.
There are two ways to get to the top of an oak tree: start climbing or sit on an acorn.
Are you a carrot, an egg, or a coffee bean?
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Prisoner#1
Even Dumber ThanAdvertized!
Registered: 01/22/03
Posts: 193,665
Loc: Pvt. Pubfag NutSuck
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: MrBump]
#10335186 - 05/13/09 10:27 PM (14 years, 11 months ago) |
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Quote:
MrBump said:
apparently the FDA thinks good health can only come from a pill.
I wonder why that is....
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zouden
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: Prisoner#1]
#10336643 - 05/14/09 07:29 AM (14 years, 10 months ago) |
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Yeah, seems like some priorities are messed up there.
Over here it's okay to make a claim like "lowers cholesterol reabsorption" if it's true. I saw that claim on a packet of oats today. And on the other hand, advertising prescription drugs is banned. I think it's better this way. Incidentally, there are only two developed countries that allow direct-to-consumer advertising of prescription drugs: USA and NZ.
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I know... that just the smallest
part of the world belongs to me
You know... I'm not a blind man
but truth is the hardest thing to see
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gluke bastid
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: Mr.Al]
#10336794 - 05/14/09 08:47 AM (14 years, 10 months ago) |
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I've gotten used to thinking of the FDA as something that needs to be scaled down and drastically restructured. I like some of what they do but I am very frustrated with the rest.
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Society in every form is a blessing,
but government at its best is but a necessary evil
- Thomas Paine
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Seuss
Error: divide byzero
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: zouden]
#10336862 - 05/14/09 09:17 AM (14 years, 10 months ago) |
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> Yeah, seems like some priorities are messed up there.
The FDA is horridly corrupt. It is a close call between them and Congress taking the top seat for the most corrupt organization in the US government with military procurement being a close third. One of the primary reasons why healthcare is so expensive in the US is because the FDA protected the profit margins of Big Pharm and the medical industry.
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Just another spore in the wind.
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gluke bastid
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: Seuss]
#10336877 - 05/14/09 09:23 AM (14 years, 10 months ago) |
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Quote:
Seuss said:
> Yeah, seems like some priorities are messed up there.
The FDA is horridly corrupt. It is a close call between them and Congress taking the top seat for the most corrupt organization in the US government with military procurement being a close third. One of the primary reasons why healthcare is so expensive in the US is because the FDA protected the profit margins of Big Pharm and the medical industry.
With a specific nod to the unbelievable inflation on the price of drugs bought in America.
I can get a 1 month supply of insulin for $25 in Canada, even less if I hop the border to Mexico. In the US its more like $350.
Thanks FDA!
--------------------
Society in every form is a blessing,
but government at its best is but a necessary evil
- Thomas Paine
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badchad
Mad Scientist
Registered: 03/02/05
Posts: 13,378
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: Seuss]
#10336879 - 05/14/09 09:23 AM (14 years, 10 months ago) |
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I think the issue at hand is whether or not you can make random claims about a particular product or not.
"a study showed 2 11/2 cup servings daily for 6 weeks reduced bad cholesterol about 4% as part of a diet low in saturated fat and cholesterol".
Who is to say the Cheerios had anything to do with the drop in cholesterol?
I could add millions of products (or behaviors) to "a diet low in saturated fat and cholesterol" and I bet bad cholesterol would decrease.
Is it fair to deceive the public into thinking a specific product at hand was responsible?
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...the whole experience is (and is as) a profound piece of knowledge. It is an indellible experience; it is forever known. I have known myself in a way I doubt I would have ever occurred except as it did.
Smith, P. Bull. Menninger Clinic (1959) 23:20-27; p. 27.
...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely.
Osmond, H. Annals, NY Acad Science (1957) 66:418-434; p.436
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gluke bastid
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: badchad]
#10337037 - 05/14/09 10:12 AM (14 years, 10 months ago) |
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Quote:
badchad said:
Is it fair to deceive the public into thinking a specific product at hand was responsible?
It is an issue. I was pretty livid when I discovered the tricky ways in which products that were labelled as whole wheat products were in fact filled with bleached flour and then added honey/molasses to them to appear as dark whole wheat.
This may seem trivial to some, but as a diabetic who has to be really intentional about his diet, there is a huge difference between plain whole wheat and white flour with added sugars.
Basically, I totally ignore any shit is says on the front of the box and go straight to the FDA label. That is one thing I am glad they do.
--------------------
Society in every form is a blessing,
but government at its best is but a necessary evil
- Thomas Paine
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zouden
Neuroscientist
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: badchad]
#10338753 - 05/14/09 04:25 PM (14 years, 10 months ago) |
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Quote:
gluke bastid said:
With a specific nod to the unbelievable inflation on the price of drugs bought in America.
I can get a 1 month supply of insulin for $25 in Canada, even less if I hop the border to Mexico. In the US its more like $350.
And over here it's $25 for 75ml, which is about 7 months' supply for me 
Though I have 2 types of insulin of course, so it's $50. But still.
Quote:
badchad said:
I think the issue at hand is whether or not you can make random claims about a particular product or not.
Oh... is that the issue? I assumed that the claims were backed up (it said "a study"). I'm all for the FDA investigating fraudulent (or poorly-supported) claims. That just seems obvious. But I thought the issue is that even truthful claims aren't allowed on food because then it classifies it as a drug.
But I admit I haven't read anything apart from other comments in this thread 
--------------------
I know... that just the smallest
part of the world belongs to me
You know... I'm not a blind man
but truth is the hardest thing to see
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gluke bastid
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: zouden]
#10338942 - 05/14/09 04:58 PM (14 years, 10 months ago) |
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Quote:
zouden said:
Quote:
gluke bastid said:
With a specific nod to the unbelievable inflation on the price of drugs bought in America.
I can get a 1 month supply of insulin for $25 in Canada, even less if I hop the border to Mexico. In the US its more like $350.
And over here it's $25 for 75ml, which is about 7 months' supply for me
Though I have 2 types of insulin of course, so it's $50. But still.
We need to become pen pals.
--------------------
Society in every form is a blessing,
but government at its best is but a necessary evil
- Thomas Paine
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Prisoner#1
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Registered: 01/22/03
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: badchad]
#10339392 - 05/14/09 06:19 PM (14 years, 10 months ago) |
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Quote:
badchad said:
Who is to say the Cheerios had anything to do with the drop in cholesterol?
because numerous studies have been done regarding oats and
cholesterol, cheerios is made from oats, I eat shit loads of
fatty foods, 6 pieces of bacon and 3 eggs, bowl of oatmeal for
breakfast, fried foods galore because I'm in the south and
that's what we do, my triglycerides are at 97, they told me I'm
also a little low on my cholesterol and my liver is in better
shape than I am, it's shaped like cuba
genetics also plays a very large role
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Prisoner#1
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: gluke bastid]
#10339427 - 05/14/09 06:24 PM (14 years, 10 months ago) |
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gluke bastid
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Registered: 12/20/00
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: Prisoner#1]
#10340132 - 05/14/09 08:39 PM (14 years, 10 months ago) |
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Quote:
Prisoner#1 said:
Quote:
gluke bastid said:
Basically, I totally ignore any shit is says on the front of the box and go straight to the FDA label. That is one thing I am glad they do.
so you go to the FDA as opposed to the research
http://www.webmd.com/cholesterol-management/cholesterol-diet-8/oats
http://www.mayoclinic.com/health/cholesterol/CL00002
http://www.healthmad.com/Nutrition/Does-Oats-Reduce-Cholesterol.450743
http://www.healthcastle.com/oats-cholesterol.shtml
http://www.cbsnews.com/stories/2007/04/18/health/webmd/main2699311.shtml
I think you misunderstood what I said.
My point was that the FDA requires food products to list all of their ingredients in order of their percentage of the whole product and in a consistent manner. That way, you can actually know whether or not the food is made with primarily whole grains if that is the first ingredient listed.
For example if you go to the grocery store and pick up a loaf of bread that says "wheat bread" or "whole wheat bread," it may in fact be made primarily with refined or bleached wheat that only has the hull of the grain left. As your studies mentioned and as people have known for quite some time, only the whole grain has nutritional value, fiber, and can lower cholesterol.
The great thing about the FDA label on the back is that it tells you what the actual primary ingredient is. So if you turn a "whole wheat" loaf over and the first ingredient is enriched wheat flour and the second ingredient is whole wheat flower, as little as 1% of the bread could be whole wheat. But if the first ingredient is whole wheat flour and no other flour types are listed, you know you are getting the real deal.
I don't leave it to the FDA to do the research at all, I just leave it to them to ensure that companies have to tell me what is in their food.
--------------------
Society in every form is a blessing,
but government at its best is but a necessary evil
- Thomas Paine
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Prisoner#1
Even Dumber ThanAdvertized!
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Re: The FDA Proving themselves to be terrorists fighting against the American People AGAIN [Re: gluke bastid]
#10340324 - 05/14/09 09:13 PM (14 years, 10 months ago) |
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Quote:
gluke bastid said:
For example if you go to the grocery store and pick up a loaf of bread that says "wheat bread" or "whole wheat bread," it may in fact be made primarily with refined or bleached wheat that only has the hull of the grain left.
if it says whole wheat bread it has to have all parts of the
wheat kernel included, doesnt have to be the entire piece of
each as a kernel makes crappy bread, in fact it can have 10% of
the wheat germ, 6% of the endosperm, 28% of the bran and the
loaf be made almost entirely of hulls as long as theres a little
of everything included, I wonder of cockroaches and rat turds
are listed in many products, salmonella wasnt listed on the
peanut butter
FDA labeling is pretty close to pointless
Quote:
As your studies mentioned and as people have known for quite some time, only the whole grain has nutritional value, fiber, and can lower cholesterol.
so what you're saying is that the cheerios claim is accurate
then and the FDA is just targeting them in order to appease the
big pharma with their cholesterol meds
http://www.thedailyplate.com/nutrition-calories/food/general-mills/whole-grain-cheerios
Quote:
The great thing about the FDA label on the back is that it tells you what the actual primary ingredient is.
any part of the wheat can be listed as wheat, since wheat is 85%
endosperm it makes only a little difference as to whether it's
whole wheat or not
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