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

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.

UsedToBeHusky

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.

Good luck with that. Kellogg's is owned by Haliburton (Richard Cheney's company). Haliburton and Big Pharma have a whole lot more money than you. And money is what matters when it comes to lobbying.

I feel like the FDA fulfills a certain need and is necessary. However, I do agree that politics and money can easily corrupt the purpose of the FDA. At the same time, however, we need the FDA to put a stop to companies that market harmful substances in the US as well, such as the HCG crap! You have to consider all sides to a story. If you really want to make a difference with the FDA, then you need to motivate a politician to make FDA reform a pet project. Then, find voting citizens to rally behind that idea and that politician. Then, you MIGHT be able to make a difference.

skir927

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.

Actually, it is. If a company is telling the public that a product lowers cholesterol, what does it matter if that product is Lipitor or breakfast cereal? Both products are regulated by the FDA and both need to bring evidence to support their claims. I have worked for several medical device companies, getting products approved/cleared by FDA and other regulatory bodies around the world, specifically focusing on advertising claims for part of that time. It is a complicated and sometimes frustrating process, but the people in these agencies are not unreasonable idiots who serve a mindless bureaucracy - they are scientists, engineers, and doctors who really do have the public health in mind.

kingkong123

...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.

hahahahahahahahaha

ARDuBaie

You are correct in stating that the members of the FDA previously held positions elsewhere, usually with food, agricultural, or pharmaceutical industries. They are basically wringers for these industries who have never lost their allegiance to the companies where they were employed.

Monsanto has been the main developer of genetically modified food, henceforth called GMOs. GMOs have been touted as being equal to their non-GMO cousins. Research is now showing that they are not equal. GMO foods often are less nutritious and lack the same taste as their non-GMO cousins. That means that the body is not being satisfied nutritionally or regarding taste, possibly leading people to overeat.

Research is also showing that GMO foods may actually increase the risk for certain types of cancer. British research has revealed that infants raised on soy-based formula have a higher risk for peanut allergies than those not raised on soy-based formulas or breast-fed. This is because the gene used to develop GMO soy came from peanuts.

Ninety percent of soy is now GMO. GMO soy is less nutritional than non-GMO soy. Vegetarians often use soy for their protein, but the protein content of GMO soy is less than non-GMO soy and it also may not be digested by the human body.

GMO corn also was made using peanut genes. Monsanto made GMO corn to be drought resistant and amenable to their Round-up herbicide. The drought resistant corn has been proven to be a dud and the use of Round-up herbicide has caused the introduction of a new fungus into the food chain.

In spite of all the problems with GMOs, the FDA has not pulled them from the shelves. Despite consumers demanding that GMOs be labeled, the FDA has sided with the agricultural industry's desires not to be forced to label GMO containing products. What are they afraid of?

Europe will not allow GMO food. What do they know that we don't know?

The FDA has been on the side of pharmaceuticals for a long time now. There is so much that I know that it makes me want to barf.

Over 100 girls have died from the Gardisil vaccination. Over 1,000 girls have suffered some sort of nerve damage from the Gardisil vaccination. Yet the FDA has not removed it from the market. The CDC, another corrupt agency, has even extended the use of the Gardisil vaccination to boys. This is a vaccination that was never really tested on humans. It was fast-tracked through the FDA approval process in order to get it on the market. Will these children be sterile when they get older? We don't know and only time will tell.

Cervical cancer is the most curable cancer. It is caught when women get a PAP smear. The Gardisil vaccination only protects against some of the forms of genital warts which may cause cervical cancer. There are others that can cause cervical cancer for which the person is not protected. So why the fast track? Money.

Hepatitis B vaccinations are given to infants as soon as they are born to protect them from medical staff who may be carrying it around on their hands. The thought is that since the staff will not get the vaccination, let's protect the child. The vaccination is very hard on the liver. Infants do not have a very developed liver, so they have trouble clearing the toxins in the vaccination. Yet the FDA allows Hepatitis B vaccinations to be given to infants.

For the life of me, we, the consumer, must be vigilant. We must educate ourselves about what we are putting into our bodies. We must voice our concerns and demand our rights in regards to labeling. In some places, organic food can be GMO food. Organic only applies to the way they are produced, not what they are produced from.

It does not surprise me at all that the FDA is threatening diamond walnuts about the omega vitamins. Look at Quaker and their oatmeal claims. If a food is helpful in preventing disease, and it is well substantiated, then the company should be able to use such in advertising.

Some books to read are Food Politics by Marion Nestle, anything by Michael Pollard. Educate yourselves and really understand what is going on.

Beezil

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.

Good luck with that. Kellogg's is owned by Haliburton (Richard Cheney's company). Haliburton and Big Pharma have a whole lot more money than you. And money is what matters when it comes to lobbying.

I feel like the FDA fulfills a certain need and is necessary. However, I do agree that politics and money can easily corrupt the purpose of the FDA. At the same time, however, we need the FDA to put a stop to companies that market harmful substances in the US as well, such as the HCG crap! You have to consider all sides to a story. If you really want to make a difference with the FDA, then you need to motivate a politician to make FDA reform a pet project. Then, find voting citizens to rally behind that idea and that politician. Then, you MIGHT be able to make a difference.

I_get_fit

I have no faith in the FDA... whatsoever!

RobynC79

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

There is a difference - you can say 'ingredient x has been shown to lower cholesterol'. You cannot say 'cheerios treat high cholesterol!'. The first is stating a known health benefit of an ingredient - even if that ingredient appears in what is otherwise a very unhealthy food product, it is a legitimate claim. The second is claiming the product treats a specific disease. Unless this is proven in a clinical trial, the FDA prevents you from stating it. Because it's untrue. Statins - shown in clinical trials to treat high cholesterol. Walnuts - have not been shown to treat high cholesterol in clinical trials. Maybe one day they will be - but until that happens, you cannot claim walnuts act as a drug (i.e., a substance treating a defined disease)

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.

There is a big difference between something being 'common sense' and something being tested and demonstrated to treat a defined disease. Natural foods do not, on their own, treat diseases. Deficiencies, in some cases, yes. Diseases, no.

Sorry.

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. ]

I think you may be slightly paranoid. There are drugs that have been tested and approved by the FDA for that.

ResilientWoman

Suziq2you

Now I want Cheerios. And walnuts.

HerbieSue

Now I want Cheerios. And walnuts.

Me too!!