Do you still have Faith in the FDA after Reading This???

Grokette

First the FDA declares Pizza the equivalent of a vegetable serving...............now they are calling Walnuts drugs??????

Please wake up people, we have got to stand together on this. People that are heading up and advisers to the FDA making the government policy are previous Monsanto attorneys and Execs.

As a matter of Fact, Michael Taylor, former attorney for the FDA has stated that we Americans do not have an inherit right to choose the food we eat for ourselves or for our families.

http://www.thenewamerican.com/usnews/health-care/8294-walnuts-are-drugs-says-fda

Walnuts Are Drugs, Says FDA

Seen any walnuts in your medicine cabinet lately? According to the Food and Drug Administration, that is precisely where you should find them. Because Diamond Foods made truthful claims about the health benefits of consuming walnuts that the FDA didn’t approve, it sent the company a letter declaring, “Your walnut products are drugs” — and “new drugs” at that — and, therefore, “they may not legally be marketed … in the United States without an approved new drug application.” The agency even threatened Diamond with “seizure” if it failed to comply.

Diamond’s transgression was to make “financial investments to educate the public and supply them with walnuts,” as William Faloon of Life Extension magazine put it. On its website and packaging, the company stated that the omega-3 fatty acids found in walnuts have been shown to have certain health benefits, including reduced risk of heart disease and some types of cancer. These claims, Faloon notes, are well supported by scientific research: “Life Extension has published 57 articles that describe the health benefits of walnuts”; and “The US National Library of Medicine database contains no fewer than 35 peer-reviewed published papers supporting a claim that ingesting walnuts improves vascular health and may reduce heart attack risk.”

This evidence was apparently not good enough for the FDA, which told Diamond that its walnuts were “misbranded” because the “product bears health claims that are not authorized by the FDA.”

The FDA’s letter continues: “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.” Furthermore, the products are also “misbranded” because they “are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.” Who knew you had to have directions to eat walnuts?

“The FDA’s language,” Faloon writes, “resembles that of an out-of-control police state where tyranny [reigns] over rationality.” He adds:

This kind of bureaucratic tyranny sends a strong signal to the food industry not to innovate in a way that informs the public about foods that protect against disease. While consumers increasingly reach for healthier dietary choices, the federal government wants to deny food companies the ability to convey findings from scientific studies about their products.

Walnuts aren’t the only food whose health benefits the FDA has tried to suppress. Producers of pomegranate juice and green tea, among others, have felt the bureaucrats’ wrath whenever they have suggested that their products are good for people.

Meanwhile, Faloon points out, foods that have little to no redeeming value are advertised endlessly, often with dubious health claims attached. For example, Frito-Lay is permitted to make all kinds of claims about its fat-laden, fried products, including that Lay’s potato chips are “heart healthy.” Faloon concludes that “the FDA obviously does not want the public to discover that they can reduce their risk of age-related disease by consuming healthy foods. They prefer consumers only learn about mass-marketed garbage foods that shorten life span by increasing degenerative disease risk.”

Faloon thinks he knows why this is the case. First, by stifling competition from makers of more healthful alternatives, junk food manufacturers, who he says “heavily lobb[y]” the federal government for favorable treatment, will rake in ever greater profits. Second, by making it less likely that Americans will consume healthful foods, big pharmaceutical companies and medical device manufacturers stand to gain by selling more “expensive cardiac drugs, stents, and coronary bypass procedures” to those made ill by their diets.

But people are starting to fight back against the FDA’s tactics. “The makers of pomegranate juice, for example, have sued the FTC for censoring their First Amendment right to communicate scientific information to the public,” Faloon reports. Congress is also getting into the act with a bill, the Free Speech About Science Act (H.R. 1364), that, Faloon writes, “protects basic free speech rights, ends censorship of science, and enables the natural health products community to share peer-reviewed scientific findings with the public.”

Of course, if the Constitution were being followed as intended, none of this would be necessary. The FDA would not exist; but if it did, as a creation of Congress it would have no power to censor any speech whatsoever. If companies are making false claims about their products, the market will quickly punish them for it, and genuine fraud can be handled through the courts. In the absence of a government agency supposedly guaranteeing the safety of their food and drugs and the truthfulness of producers’ claims, consumers would become more discerning, as indeed they already are becoming despite the FDA’s attempts to prevent the dissemination of scientific research. Besides, as Faloon observed, “If anyone still thinks that federal agencies like the FDA protect the public, this proclamation that healthy foods are illegal drugs exposes the government’s sordid charade.”

Grokette

bump

just_a_southern_belle

Guess I need to Google Monsanto because I am clueless. But no I do not trust government agencies. There is always a political motive or a financial one or both

Grokette

Guess I need to Google Monsanto because I am clueless. But no I do not trust government agencies. There is always a political motive or a financial one or both

Monsanto is the company that make the poison Round Up, which is a herbicide. Monsanto is the main company behind GMO's and all the Genetically modified fruits and vegetables, grains out here that people are eating, which is not healthy.

Michael Taylor is a former Monsanto attorney who now makes the Policy for the FDA.

He has stated in the past this very statement: People have no inherent right to choose the food they eat or what they feed their children.

http://foodfreedom.wordpress.com/2010/05/09/fda-you-have-no-natural-right-to-food-health-or-private-contracts/

Coyla

I haven't listened to the FDA for awhile. I don't rely on a government agency to decide what to eat. I go with what works. We all need to be responsible for our own food choices.

jennajava

I don't have faith in any acronym that begins with the word "federal."

athensguy

You aren't allowed to make certain medical claims without FDA approval. I don't see a problem with that.

daphnegetnfit

Never trusted the FDA in the first place

adjones5

I've never had faith in the FDA.

rugbyphreak

i grow most of my own food without chemicals or additives, so i never listen to them. i eat what i want and i enjoy my freedoms. the government can't do what's right for every single citizen all the time.

Grokette

You aren't allowed to make certain medical claims without FDA approval. I don't see a problem with that.

Stating Health benefits of a food is not the same as making medical claims.

Grokette

i grow most of my own food without chemicals or additives, so i never listen to them. i eat what i want and i enjoy my freedoms. the government can't do what's right for every single citizen all the time.

The problem is, we are becoming a police state and I read some place a couple of weeks ago that they are going to make it illegal to grow your own food in the near future.

Grokette

i grow most of my own food without chemicals or additives, so i never listen to them. i eat what i want and i enjoy my freedoms. the government can't do what's right for every single citizen all the time.

This judge sided with the FDA..................And it is funny that Michael Taylor (former Monsanto) said nearly the same thing.

According to Wisconsin Judge Patrick J. Fiedler, you do not have a fundamental right to consume the food you grow or own or raise. The Farm To Consumer Legal Defense Fund, the pioneers in defending food sovereignty and freedom, recently argued before Judge Fiedler that you and I have a constitutional right to consume the foods of our choice. Judge Fiedler saw no merit to the argument and ruled against the FTCLDF. When they asked him to clarify his statement, these were his words:


“no, Plaintiffs do not have a fundamental right to own and use a dairy cow or a dairy herd;”
“no, Plaintiffs do not have a fundamental right to consume the milk from their own cow;”
“no, Plaintiffs do not have a fundamental right to produce and consume the foods of their choice…”

YassSpartan

I know some fans of mine in this website will probably respond to my reply, but whatever.

FDA is full of crap as many or most government agencies. They work based on the influence of lobbyist. They're a bunch of people who have no clue and do what they're told based on the amount of $ they receive.

Val_from_OH

I work for a company that is regulated by the FDA, and we have a lot of meetings that end with "You've got to be kidding! The FDA says that we can't say that?!!!"

In this case, I can't believe that they actually put into writing that Walnuts are a drug. Did anyone proof-read that letter?

On the other hand, I completely understand why the FDA prevents food companies from providing this type of labeling. MFP people are food-smart, but not everyone is. My MIL is convinced that she can eat high-saturated-fat, high-sodium foods all day, but as long as she is getting her Omega 3's, she will not get heart disease. I hate to tell you, but a handful of walnuts a day is not going to cancel out all that bacon.

In order for supplements to really work, they must be taken in a controlled way, as part of a controlled diet, and generally, real people do not eat the same way as the people participating in a study. I do believe that walnuts are a healthier choice, than say, Fritos, and Diamond should be able to claim that. However, they should not be indicating that Walnuts prevent heart disease. That is just asking for a lawsuit....

LuckyLeprechaun

i grow most of my own food without chemicals or additives, so i never listen to them. i eat what i want and i enjoy my freedoms. the government can't do what's right for every single citizen all the time.

The problem is, we are becoming a police state and I read some place a couple of weeks ago that they are going to make it illegal to grow your own food in the near future.

You.....HEARD!????? OH GOD NO!!!!!!!!!!


SHE HEARD IT!!!!!


It must be true!!!!!!!!!!!!!!


Who told you!!!!!!????????????? It was THEM!!!! THEY said it!!!! OHHHHHHGOOOOOOOOOOOD the sky is falling...............

UsedToBeHusky

Ah... the fine lines of marketing...

The difference between what Lay's did and what Diamond did is simply about the wording. Lay's made a generic statement "heart-healthy." They did not describe what about their product was "heart-healthy" and so they can legally get away with that because they made no claim to how their product was "heart-healthy". On the other hand, Diamond was very specific about what elements of their products offered health benefit. The issue for the FDA is that they have not run their own study to investigate that claim, even though others have. This is more about the laws governing false claims in advertising more than anything else. If Diamond had simply put "heart-healthy" on their packaging, there would not have been a problem for the FDA.

As far as the reference to walnuts being described as drugs, I am thinking that someone somewhere screwed up and used the wrong form letter.

Lesa_Sass

Okay people before we take this kind of thing on blind faith, we need to do some investigation into the matter.


Actually, the issue is, that the company was trying to make claims on the packaging that walnuts can be used to prevent and cure illness.

YassSpartan

I know some fans of mine in this website will probably respond to my reply, but whatever.

FDA is full of crap as many or most government agencies. They work based on the influence of lobbyist. They're a bunch of people who have no clue and do what they're told based on the amount of $ they receive.

And I'm not trying to hijack your post, but to give you another example about how stupid agencies are, not only in United States but also around the world, did you ever hear that the EU banned claims that water can prevent dehydration?

http://www.telegraph.co.uk/news/worldnews/europe/eu/8897662/EU-bans-claim-that-water-can-prevent-dehydration.html

kingkong123

You aren't allowed to make certain medical claims without FDA approval. I don't see a problem with that.

Stating Health benefits of a food is not the same as making medical claims.

"...the company stated that the omega-3 fatty acids found in walnuts have been shown to have certain health benefits, including reduced risk of heart disease and some types of cancer."

That's a medical claim.

Also - the tomato sauce in pizza was determined to be a vegetable. Obviously, they didn't just deem pizza a vegetable. That would be ridiculous for various reasons, among which is the fact that it is comprised of various ingredients...sauce, dough, cheese, etc. But I'm sure that topic got drilled on here.

kelseyhere

I ate walnuts with my oatmeal this morning at breakfast, does that mean I'm high?

Lesa_Sass

http://www.fda.gov/iceci/enforcementactions/warningletters/ucm202825.htm


Diamond Food Inc. 2/22/10

Department of Health and Human Services logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration
College Park, MD 20740


FEB 22 2010



WARNING LETTER


VIA OVERNIGHT MAIL


Michael J Mendes, President and Chief Executive
Diamond Food, Inc.
1050 S. Diamond St.
Stockton, California 95201


Re: CFSAN-OC-10-11


Dear Mr. Mendes:


The Food and Drug Administration (FDA) has reviewed the label for your "Diamond of California Shelled Walnuts" products and your website at www.diamondnuts.com. Based on our review, we have concluded that your walnut products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA's home page at http://www.fda.gov.


Website


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. Additionally, your walnut products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your walnut products are also misbranded under section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].


Your walnut products are also misbranded under section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] because your firm's website also contains several additional unauthorized health claims. The following are examples of the claims made on your firm's website:


• "Studies have also shown that omega-3s may lower the risk of stroke ..."


• "[T]here's good evidence that omega-3s can increase HDL (good cholesterol), further reducing the risk of stroke and heart disease."


Product Label


Further, your "Diamond of California Shelled Walnut" product is misbranded under section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] in that your product bears health claims that are not authorized by the FDA. The front and back of your product label bears the phrase "OMEGA 3 2.5 g per serving." Within the context of this label, the heart symbols adjacent to information about the amount of omega-3 in the product, constitute implied health claims about consumption of omega-3 and a reduced risk of coronary heart disease [21 CFR 101. 14(a)].


The back of your product label also bears the following statement: "The omega-3 in walnuts can help you get the proper balance of fatty acids your body needs for promoting and maintaining heart health. In fact, according to the Food and Drug Administration, supportive but not conclusive research shows that eating 1.5 oz of walnuts per day, as part of a low saturated fat and low cholesterol diet, and not resulting in increased caloric intake, may reduce the risk of coronary heart disease. Please refer to nutrition information for fat content and other details about the nutritional profile of walnuts." Although FDA exercises enforcement discretion over the last two sentences of this statement, which meet the criteria for a qualified health claim for walnuts and coronary heart disease, the last two sentences read in conjunction with the first sentence makes the entire statement an unauthorized health claim.


The statement suggests that the evidence supporting a relationship between walnuts and coronary heart disease is related to the omega-3 fatty acid content of walnuts. There is not sufficient evidence to identify a biologically active substance in walnuts that reduces the risk of CHD. Therefore, the above statement is an unauthorized health claim. This letter is not intended to be an inclusive review of your products and their labeling. It is your responsibility to ensure that all of your products comply with the Act and its implementing regulations.


You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response documentation such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.


Your response should be directed to Latasha Robinson, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, you may contact Ms. Robinson at 301-436-1890.

Sincerely,

/S/

Roberta Wagner
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition

RobynC79

There is an important difference between claiming something has a health benefit and claiming that it can be used to treat, prevent or otherwise affect a medical condition. Apparently the walnuts were labeled in such a way as to imply the latter, hence the FDA's response - 'if you want to say that about walnuts, then you are effectively promoting them as a drug'. Which is and should be unallowable until whatever that product is has gone through clinical trials and completed the full approval process.

For everyone who mistrusts the FDA - who would you prefer to be approving your medical treatments? While the FDA is a target of lobbying and is certainly imperfect, it is at least not a profit-driven corporation.

As for the lengthy window-dressing of the unconstitutionality of the FDA and allowing the 'educated consumer' to correct false statements about health... I'm leaving that one well alone.

Slove009

Oh crap! I need to hide my stash now!!!

And no.... no more faith in them.

Grokette

It is still not making medical claims, it is saying hey, this may improve your health.

The whole point I am getting at is Kellogs, General Mills and a host of other companies (mostly grain companies) are all saying how their WHOLE GRAIN GOODNESS lowers cholesterol and such, but the FDA is not going after them.

See the double standard?

Why isn't the FDA going after these grain companies????????????

Because of Michael Taylor and his affiliations with Monsanto and now the FDA and the grain subsidies that is all mighty and powerful in this country.

If people can't see this, you are truly blind.

UsedToBeHusky

Well first off...

This is an old letter, and I would think by now that the issue has already been resolved. Secondly, all of those claims were in fact medical claims, and the FDA does reserve the right to challenge those claims, if the agency itself has not conducted its own studies and found support for those claims. The "drugs" aspect of this baffles me, but all I can think is that the comparison was made for impact.

Grokette

There is an important difference between claiming something has a health benefit and claiming that it can be used to treat, prevent or otherwise affect a medical condition. Apparently the walnuts were labeled in such a way as to imply the latter, hence the FDA's response - 'if you want to say that about walnuts, then you are effectively promoting them as a drug'. Which is and should be unallowable until whatever that product is has gone through clinical trials and completed the full approval process.

For everyone who mistrusts the FDA - who would you prefer to be approving your medical treatments? While the FDA is a target of lobbying and is certainly imperfect, it is at least not a profit-driven corporation.

As for the lengthy window-dressing of the unconstitutionality of the FDA and allowing the 'educated consumer' to correct false statements about health... I'm leaving that one well alone.

I want to see them go after General Mills then for claiming Cheerios lowers cholesterol then too. It is the same thing. The FDA is going after raw milk farmers, now nut companies, basically any company that is not affiliated with grains and Monsanto.

I wonder why they leave these grain companies alone???????????

And I don't see anything on Daimond of California website that says any such thing..........

http://www.diamondnuts.com/products/culinary/walnuts/

Under Benefits:

Benefits
Walnuts are full of healthy benefits: they are a great source of protein and fiber and contain significant amounts of thiamin, vitamin B6, folacin and vitamin E. Other mineral value comes from iron, zinc, copper, magnesium, phosphorus and potassium.

UsedToBeHusky

It is still not making medical claims, it is saying hey, this may improve your health.

What exactly is a medical claim then, in your opinion? Lay's generic statement "heart-healthy" is saying this may improve your health. Diamond specifically claimed that eating walnuts will shrink tumors!!

Grokette

I know some fans of mine in this website will probably respond to my reply, but whatever.

FDA is full of crap as many or most government agencies. They work based on the influence of lobbyist. They're a bunch of people who have no clue and do what they're told based on the amount of $ they receive.

Thank You. They are taking over our country with Monsanto leading the way for them. Many former Monsanto employees are heading up the FDA, USDA and making the policies for this country.

UsedToBeHusky

There is an important difference between claiming something has a health benefit and claiming that it can be used to treat, prevent or otherwise affect a medical condition. Apparently the walnuts were labeled in such a way as to imply the latter, hence the FDA's response - 'if you want to say that about walnuts, then you are effectively promoting them as a drug'. Which is and should be unallowable until whatever that product is has gone through clinical trials and completed the full approval process.

For everyone who mistrusts the FDA - who would you prefer to be approving your medical treatments? While the FDA is a target of lobbying and is certainly imperfect, it is at least not a profit-driven corporation.

As for the lengthy window-dressing of the unconstitutionality of the FDA and allowing the 'educated consumer' to correct false statements about health... I'm leaving that one well alone.

I want to see them go after General Mills then for claiming Cheerios lowers cholesterol then too. It is the same thing. The FDA is going after raw milk farmers, now nut companies, basically any company that is not affiliated with grains and Monsanto.

I wonder why they leave these grain companies alone???????????

And I don't see anything on Daimond of California website that says any such thing..........

http://www.diamondnuts.com/products/culinary/walnuts/

Under Benefits:

Benefits
Walnuts are full of healthy benefits: they are a great source of protein and fiber and contain significant amounts of thiamin, vitamin B6, folacin and vitamin E. Other mineral value comes from iron, zinc, copper, magnesium, phosphorus and potassium.

Well... General Mills paid lobbyists that elicited the FDA to study the potential "cholosterol lowering" effects of Cheerios.

Grokette

It is still not making medical claims, it is saying hey, this may improve your health.

What exactly is a medical claim then, in your opinion? Lay's generic statement "heart-healthy" is saying this may improve your health. Diamond specifically claimed that eating walnuts will shrink tumors!!

I want them to go after General Mills and Kelloggs and all these other companies making the same claims of lowering cholesterol and such.

They won't do it because Monsanto, The FDA, USDA and these grain companies are all lobbying for this stuff, so they won't be touched.

And I will believe the claims of many natural food companies over some government entity that wants to put every single person in this country on some type of prescription medication, make people sicker, fatter and more dependent on drugs.

Many natural foods, such as nuts, vegetables, fats (coconut oil), fruit truly have healing abilities - The FDA does not want people to know that. The writing is on the wall and it is very common sense.

I am standing up to this and I, along with a doctor of mine are forming a group to start lobbying for the stoppage of this nonsense.