Drugs are Nuts

Stefan Fincken
September 16th 2011

Thinking about Next Nature can sometimes result in a feeling of vertigo. Normal standards are eroded and slowly replaced by next natural ones. A bewildering example can be found in a letter the Food and Drug Administration (FDA) sent to a manufacturer of walnuts.

"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 claaims 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."

Diamond Foods Incorporated, who marketed the walnuts, apparently made some health claims the FDA didn't aprove of:

• "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."
• "Omega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats ... "
• "In 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."

Now here comes the kicker:

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)]..." You can read the full letter here.

Did you feel that? The world just turned upside down, leftside right and inside out. The FDA, which was signed into law in 1906 by Roosevelt, has, in a strange twist of logic, classified walnuts, which have been with us since 7000 B.C. acording to some sources, as an unlicensed drug.

The FDA argues that the health claims  that accompany the walnuts brand them as a drug. A drug that isn't aprroved by the FDA, and thus illegal to sell. Any sane human being knows that a walnut is nothing to fear, except maybe as a chocking hazard. And indeed some studies suggest they have beneficial effects on cognition:
"Diets containing two percent, six percent, or nine percent walnuts, when given to old rats, were found to reverse several parameters of brain aging, as well as age-related motor and cognitive deficits, says James Joseph, PhD, of the U.S. Department of Agriculture Human Nutrition Research Center at Tufts University in Boston."

Another article claims:
"Tests showed that both the olive oil and the walnuts helped to reduce the sudden onset of harmful inflammation and oxidation in arteries that follows a meal high in saturated fat... However, unlike olive oil, adding walnuts also helped preserve the elasticity and flexibility of the arteries, regardless of cholesterol level."

As a child, a friend of mine had a walnut tree in their garden. We used to climb it and play around it. We could spend whole days collecting the fallen nuts. Breaking the hard shells and eating the brainlike structures inside until we were full. I'm still standing, even though I ate a small mountain of the things. Labelling walnuts as a drug is nuts. Next nature can be nuts.

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john sucks
Posted 19/09/2011 – 22:25

No John, you're wrong. Well, you're right about them being annoyed. The fda is a revolving door for pharma industry board members. The health food industry is starting to become competition for the pharma industry. more people than ever are demanding organic and local foods, and holistic treatments. If you think I'm full of shit you haven't researched enough.

John
Posted 18/09/2011 – 05:08

It's not that they're drugs or not, it's that the FDA has ruled that that company was marketing them as a drug. The FDA was probably annoyed at them for making all those health claims; I've heard of them threatening health food makers in like manner.

Should men be able to give birth to children?


Lisa Mandemaker: Using an artificial womb could lead to more equality between sexes, but also between different family layouts. If men would be able to give birth to children, it would maybe be easier for male same-sex couples to have a child together.

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