FDA, healthy foods, new drugs, unapproved drugs, health claims, Sin Hang Lee, Diamond nut company, green tea, Beach-nut nutrition, Pompeian’s Extra Light Olive Oil

Let Your Food Be Your Medicine

Let Your Food Be Your Medicine

Hippocrates, who lived in Greece approximately 2,400 years ago is often quoted as saying, “Let your food be your medicine, and medicine be food.” Were Hippocrates living in the United States today he would undoubtedly be shocked to discover how literally his words are being taken by regulatory authorities.

Earlier this year the FDA sent out a number of warning letters to individuals and companies who distribute food products. In the letters the FDA declares certain foods to be “new and unapproved drugs” by virtue of the fact that the distributor has referenced studies that have shown that consuming the food has a beneficial effect on health. The FDA does not dispute the study findings; it simply states that the results cannot be made known to potential consumers of the product. Had I not found the actual letters on the official FDA website I would have assumed their purported existence to be a hoax.

On February 22, 2010 a letter was sent to Michael Mendes, President of the Diamond Food Company of Stockton, California, warning him that thewalnuts the company was selling were a "new and unapproved drug" by virtue of the fact that the company website provided evidence that consuming omega-3 oils is helpful in supporting the body’s ability to ward off disease.

It seems the Diamond Food Company had committed two grievous sins: It had pointed out that walnuts are rich in omega 3 fatty acids and it had referenced studies showing that omega 3 oils may help lower cholesterol, protect against heart disease, stroke, some cancers, ease arthritis and other inflammatory diseases, and fight depression and other mental illnesses.

Those studies exist, of course, but pointing out their results to the general public is not permissible in a society where pharmaceutical agents are the only acceptable tools in the battle against disease. The FDA letter pointed out that walnuts have not been shown to be safe and effective in the management of medical conditions, inferring that FDA approved drugs, which are known to cause tens of thousands of deaths and dramatically lower the quality of life in many who take them, are "safe and effective". Ironically, the FDA has approved Lovaza, a pharmaceutical strength omega 3 product, as "safe and effective". (Lovaza is approved for lowering of triglycerides, but not forprevention of heart disease.)

The FDA went on to state that "adequate directions for use of the walnuts cannot be written so that a layperson can use these drugs safely for their intended purposes." Yes, indeed, someone who does not possess a medical degree is not competent to follow directions such as 1) Open can. 2) Sprinkle some walnuts into your hand. 3) Place the walnuts in your mouth 4) Chew thoroughly 5) Swallow.

The pettiness of the FDA's declaration can be seen by the fact that the FDA itself has stated that studies suggest that eating 1.5 ounces of walnuts daily may reduce the risk of heart disease. Because Diamond Food Company attributed this benefit to the presence of omega-3 oils (on the basis of published omega 3 studies), they were charged with making an unsubstantiated health claim!

On that same date a letter was sent to Sin Hang Lee, MD, FRCP (C), who advocates drinking green tea as a protective strategy against the development of cancer and other health challenges. Dr. Lee is a highly respected cancer researcher. In 2005 Dr. Lee published a ten page article, Re-introducing Tea to the West - This Time to Fight Cancer in which he discussed twelve mechanisms by which green tea helps the body reduce cancer risk. His paper cited 100 references. Interestingly, Dr. Lee used the “Let food be your medicine” quote to introduce the article. Having lived in Hong Kong and attended medical school there, Dr. Lee credited Shennong with first offering that advice in 2737 BC.

The product in question was Dr. Lee’s Tea For Health, which is imported from China where it is grown organically and processed on site. Dr. Lee did not make health claims on the teaforhealth.com website where the tea is sold, but the site linked to a second site, greenteahaus.com, where 226 published scientific studies documenting the benefits of green tea are listed.

The FDA referred to the studies as “educational materials” (the quotes implying that the scientific articles were not, in fact, educational.) Although the site provided 130 studies showing a benefit in reducing the risk of cancer development and improvement in length of survival in cancer patients, these were declared to be “unauthorized health claims”.

The suggestion that green tea consumption might prevent cancer makes it, under FDA statute a “drug”. Because it has not been shown to be “safe and effective” green tea was also declared a new and unapproved drug. There is no longer any mention of the cancer protective benefits of green tea on the teaforhealth.com website and the link to greenteahaus.com has been removed.

Ken’s Foods ran afoul of the FDA because several of its “Healthy Options” salad dressings contained more than 3 grams of fat per serving. According to FDA regulations only low fat or no fat dressings can be labeled as “healthy”. It appears that no one has informed the regulators that fat soluble nutrients require the presence of fat in the meal to be optimally absorbed in the body or that a Mediterranean diet that is rich in oils has been shown to be the style of eating associated with the best health and greatest longevity.

Beach-Nut Nutrition was cited for, among other things, stating that its baby food had no added refined sugar – a claim not allowed on products intended for consumption by infants and children under two years of age. How notifying a parent that refined sugar has not been added to a baby food product will potentially cause harm to the infant or child escapes me. Perhaps we have come to the point where we believe infants are in danger of dying from a refined sugar deficiency. (More likely the rule is intended to protect baby food manufactures who do add refined sugar to their products.) Gerber’s Carrots were also found guilty of the offense of stating that no refined sugar had been added to the product. The company also erred by suggesting that carrots are an excellent source of vitamin A, as such claims are not allowed on a food product marketed for use by infants and children under the age of 2.

Pompeian’s Extra Light Olive Oil was declared a drug because of statements on the company’s website such as "Olive Oil is a major component of the Mediterranean diet, which protects the heart, may lower inflammation and coagulation, and may reduce mortality in the elderly." Because it may help prevent disease, olive oil is now a new and unapproved drug that has not been proven safe for consumption or effective for the conditions it is helpful in preventing.

I could go on, but I have already belabored the point. The health of our society is in serious danger when consumers cannot be told the benefits of including certain foods in their diet. Declaring foods that have been consumed for millennia new and unapproved drugs does not serve the interests of society or the individual. It only serves to keep people enslaved to foods and beverages loaded with refined sugars and laden with FDA approved additives and preservatives, few of which have ever been tested and shown to be safe for ongoing consumption.

In my opinion we are living in perilous times. Regulatory agencies such as the FDA are out of control and are establishing guidelines and making rulings that are completely out of touch with reality. My friends, the lunatics are definitely running the asylum!


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