June 28, 2010 Author: Susan Anderson
My Confession
I am not one to describe myself as an illegal drug user, so you can just imagine how horrified I was to learn that I have been concealing and using an illegal substance in my home for years. On top of that I have also turned my beloved family members - my husband and two daughters- into drug users as well! Come to think of it I have even given some of our contraband to my elderly parents, as well as to unsuspecting guests who have visited our home. In regard to my family, their addictions can be directly traced back to me. And the biggest kicker-- I had no idea I was involved in such unlawful behavior.
Violation of the RICO Act
The past few nights have been especially difficult. Unable to sleep, tossing and turning, breaking out into night sweats, and once even scurrying under the bed to hide when an unfamiliar sound rattled loudly below the bedroom window. Why you might ask? My mind has been working overtime, probably from watching too many Lifetime Movies-- I am expecting at any minute that the FBI will come busting onto our property and arrest me for violation of the RICO Act (Racketeer Influenced and Corrupt Organizations).
Ignorance is No Excuse
One of the offenses included under the RICO Act is drug trafficking- and for that my dear friends, I figure I can be punished to the full extent of the law. Although it is taking great courage for me to write this article, I feel it is my duty to inform you, that you too most likely, are as guilty as I am. Therefore let me remind everyone out there " Ignorantia legis neminem excusat " (Latin for "ignorance of the law excuses no one") is a legal principle in our country which holds that a person who is unaware of a law may not escape liability for violating that law merely because he or she was unaware of its content. And as far as criminal law goes, ignorance on our part is not likely to relieve us of a guilty verdict, but the good news is-- the judge may take this into consideration at sentencing. A little bit of hope lights the way before us!
FDA Issues Warning to Diamond Food
So by now you must be wondering what drug I am referring to, that would have each of us teetering on the brink of arrest? Why it is the our addictive cravings for the mighty, all powerful WALNUT! Although, at this point, the only individuals breaking the law are the users of Diamond Brand Walnuts. On February 22, 2010 the FDA issued a warning letter to Michael J Mendes, President and Chief Executive of Diamond Food, Inc. After reviewing their product label and website regarding Diamond Shelled Walnuts they were found in violation of the Federal Food, Drug and Cosmetic Act.
FDA: Walnuts Are Drugs
The FDA stated that "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 specific law breaking violations mentioned by the FDA that were found on Diamond Foods packaging labels or website, included:
" 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 ... "
FDA: "Walnuts- This Drug is NOT Generally Recognized as Safe"
"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)]."
Hmm, how many walnuts have I consumed lately in one sitting? I consider myself extremely lucky for not overdosing. The fact is- due to my addiction to this drug, I may have as many as a cup full of them at one time. Can anyone out there recommend a good 12-step program for Walnut addiction?
More Health Claim Violations
The FDA warning letter continues "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 Mislabeling
"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."
Whew! I'm Glad the FDA is Looking Out For Us
Can you imagine what danger we would all be in if the FDA did not do this important work of protecting us against unscrupulous companies such as Diamond Food! We just might be forced to reduce the use of legalized, prescription medications endorsed by the pharmaceutical companies. Instead we could be backed into a corner and have to use more unproven, unrecognized as safe, natural substances such as, well, dare I say it- that four letter word that begins with an F.... FOOD.
More Illegal Drugs
As I explored the FDA's website section for Inspections, Compliance, Enforcement, and Criminal Investigations, I was dumbfounded at the some of the other products I am currently using in an unlawful way, in particular homeopathic remedies and supplements. Guess I am going to need to put this website on my favorites list so I can check out the new warning letters regularly issued. Now that my criminal activity is out in the open for all to read about, I want to make sure I do not repeat the same crimes over and over again, because I know that my ignorance of the law will not save me.
Don't Believe Me?
Well if you think I am making this all up, check out the letter sent to Diamond Foods yourself. Then go to the left side of the page and begin to check out the warning letters under the Enforcement Actions column. All kidding aside, although I have tried to put a humorous slant to this article, in a nutshell, it really is no laughing matter. We need to be aware of what is going on, stand up for our beliefs and support those who are taking a proactive approach to protecting our rights.
So What Can I Do?
Participate in the various action alerts that are available on the internet letting your voice be heard. One organization working diligently and effectively to protect our natural health rights including health freedom threats from Codex, the FDA, vaccinations, and GMO is the Natural Solutions Foundation.
1. Visit their website to become familiar with the issues.
2. Sign the Citizens Petition- Read what it is about here.
So in conclusion, I would like to end with the words regularly spoken by Jeff Frank, Director of the Nature Lyceum : "We are all in this together."
.
Read more!
My Confession
I am not one to describe myself as an illegal drug user, so you can just imagine how horrified I was to learn that I have been concealing and using an illegal substance in my home for years. On top of that I have also turned my beloved family members - my husband and two daughters- into drug users as well! Come to think of it I have even given some of our contraband to my elderly parents, as well as to unsuspecting guests who have visited our home. In regard to my family, their addictions can be directly traced back to me. And the biggest kicker-- I had no idea I was involved in such unlawful behavior.
Violation of the RICO Act
The past few nights have been especially difficult. Unable to sleep, tossing and turning, breaking out into night sweats, and once even scurrying under the bed to hide when an unfamiliar sound rattled loudly below the bedroom window. Why you might ask? My mind has been working overtime, probably from watching too many Lifetime Movies-- I am expecting at any minute that the FBI will come busting onto our property and arrest me for violation of the RICO Act (Racketeer Influenced and Corrupt Organizations).
Ignorance is No Excuse
One of the offenses included under the RICO Act is drug trafficking- and for that my dear friends, I figure I can be punished to the full extent of the law. Although it is taking great courage for me to write this article, I feel it is my duty to inform you, that you too most likely, are as guilty as I am. Therefore let me remind everyone out there " Ignorantia legis neminem excusat " (Latin for "ignorance of the law excuses no one") is a legal principle in our country which holds that a person who is unaware of a law may not escape liability for violating that law merely because he or she was unaware of its content. And as far as criminal law goes, ignorance on our part is not likely to relieve us of a guilty verdict, but the good news is-- the judge may take this into consideration at sentencing. A little bit of hope lights the way before us!
FDA Issues Warning to Diamond Food
So by now you must be wondering what drug I am referring to, that would have each of us teetering on the brink of arrest? Why it is the our addictive cravings for the mighty, all powerful WALNUT! Although, at this point, the only individuals breaking the law are the users of Diamond Brand Walnuts. On February 22, 2010 the FDA issued a warning letter to Michael J Mendes, President and Chief Executive of Diamond Food, Inc. After reviewing their product label and website regarding Diamond Shelled Walnuts they were found in violation of the Federal Food, Drug and Cosmetic Act.
FDA: Walnuts Are Drugs
The FDA stated that "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 specific law breaking violations mentioned by the FDA that were found on Diamond Foods packaging labels or website, included:
" 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 ... "
FDA: "Walnuts- This Drug is NOT Generally Recognized as Safe"
"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)]."
Hmm, how many walnuts have I consumed lately in one sitting? I consider myself extremely lucky for not overdosing. The fact is- due to my addiction to this drug, I may have as many as a cup full of them at one time. Can anyone out there recommend a good 12-step program for Walnut addiction?
More Health Claim Violations
The FDA warning letter continues "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 Mislabeling
"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."
Whew! I'm Glad the FDA is Looking Out For Us
Can you imagine what danger we would all be in if the FDA did not do this important work of protecting us against unscrupulous companies such as Diamond Food! We just might be forced to reduce the use of legalized, prescription medications endorsed by the pharmaceutical companies. Instead we could be backed into a corner and have to use more unproven, unrecognized as safe, natural substances such as, well, dare I say it- that four letter word that begins with an F.... FOOD.
More Illegal Drugs
As I explored the FDA's website section for Inspections, Compliance, Enforcement, and Criminal Investigations, I was dumbfounded at the some of the other products I am currently using in an unlawful way, in particular homeopathic remedies and supplements. Guess I am going to need to put this website on my favorites list so I can check out the new warning letters regularly issued. Now that my criminal activity is out in the open for all to read about, I want to make sure I do not repeat the same crimes over and over again, because I know that my ignorance of the law will not save me.
Don't Believe Me?
Well if you think I am making this all up, check out the letter sent to Diamond Foods yourself. Then go to the left side of the page and begin to check out the warning letters under the Enforcement Actions column. All kidding aside, although I have tried to put a humorous slant to this article, in a nutshell, it really is no laughing matter. We need to be aware of what is going on, stand up for our beliefs and support those who are taking a proactive approach to protecting our rights.
So What Can I Do?
Participate in the various action alerts that are available on the internet letting your voice be heard. One organization working diligently and effectively to protect our natural health rights including health freedom threats from Codex, the FDA, vaccinations, and GMO is the Natural Solutions Foundation.
1. Visit their website to become familiar with the issues.
2. Sign the Citizens Petition- Read what it is about here.
So in conclusion, I would like to end with the words regularly spoken by Jeff Frank, Director of the Nature Lyceum : "We are all in this together."
.
