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Well the Food and Drug Administration has really made a name for themselves this time. In response to claims by a company named Diamond Foods that walnuts possess health benefits, the FDA sent the company a letter informing them of their wrongdoing. What did Diamond Foods do wrong? According to the FDA, claims made by Diamond Foods that omega-3′s found in walnuts produce health benefits make their walnuts "drugs". As far as the FDA is concerned, these "drugs" can not be legally marketed in the United States without an approved new drug application.
FDA Actions Portray Government Lunacy at its Best
It seems bureaucratic tyranny is really taking shape in America. Despite 35 peer-reviewed published papers showing that walnuts improve vascular health and promote heart function being held in the US National Library of Medicine database, the FDA refuses to allow Diamond Foods to make such claims. The evidence revolving around the benefits of walnuts evidently must be authorized by the FDA before those benefits can even be marketed. A letter sent to the company from the FDA states:
"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."
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.
Originally posted by Narcissous
at first i thought it was a typo, since nutmeg is the one which causes hallucinations, but this is crazy.