FDA Says Walnuts Are Illegal Drugs

[Bim]

What? http://www.lef.org/magazine/mag2011/aug2011_FDA-Says-Walnuts-Are-Illegal-Drugs_01.htm


FDA Says Walnuts Are Illegal Drugs


Life Extension® has published 57 articles that describe the health benefits of walnuts.

Some of this same scientific data was featured on the website of Diamond Foods, Inc., a distributor of packaged walnuts.

Last year the FDA determined that walnuts sold by Diamond Foods cannot be legally marketed because the walnuts “are not generally recognized as safe and effective” for the medical conditions referenced on Diamond Foods’s website.

According to the FDA, these walnuts were classified as “drugs” and the “unauthorized health claims” cause them to become “misbranded,” thus subjecting them to government “seizure or injunction.”

Diamond Foods capitulated and removed statements about the health benefits of walnuts from its website.

Let’s take a look at the science supporting the consumption of walnuts to see what the FDA censored…and what you can do to stop it in the future!
Eating Walnuts Cuts Heart Disease Risk

Ingesting nuts used to be considered unhealthy because of their high fat content. This misconception has changed over the past 18 years as human studies have revealed sharply reduced incidence of heart disease in those who consume walnuts.1-12
Unlike some nuts, walnuts provide a unique blend of polyunsaturated fatty acids (including omega-3s), along with nutrients like gamma-tocopherol that have demonstrated heart health benefits.13-24

The March 4, 1993, issue of the New England Journal of Medicine published the first clinical study showing significant reductions in dangerous LDL and improvement in the lipoprotein profile in response to moderate consumption of walnuts.14 Later studies revealed that walnuts improve endothelial function in ways that are independent of cholesterol reduction.1, 25-27

One study published by the American Heart Association journal Circulation on April 6, 2004, showed a 64% improvement in a measurement of endothelial function when walnuts were substituted for other fats in a Mediterranean diet.1

As most Life Extension members are aware, the underlying cause of atherosclerosis is progressive endothelial dysfunction.28

Walnuts contain a variety of nutrients including arginine, polyphenols, and omega-3s that support the inner arterial lining and guard against abnormal platelet aggregation.2,13,29-31 These favorable biological effects explain why walnut consumption confers protection against coronary artery disease.

The US National Library of Medicine database contains no fewer than 35 peer-reviewed published papers supporting a claim that ingesting walnuts improves vascular health and may reduce heart attack risk.

FDA Ignores the Science

The federal agency responsible for protecting the health of the American public views this differently.

On our website, we reprint the FDA’s entire warning letter to Diamond Foods. Nowhere in this bureaucratic albatross is there any discussion of the science cited by Diamond Foods to support their health claims.

Instead, the FDA’s language resembles that of an out-of-control police state where tyranny reins over rationality. To enable you to recognize the absurdity of all of this, I excerpted a few paragraphs from the FDA’s warning letter to Diamond Foods starting below.32

Excerpt from FDA Letter “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).

“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.

“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)].”

This verbiage makes it clear that the FDA does not even consider the underlying science when censoring truthful, non-misleading health claims. The chilling effect on the ability of consumers to discover lifesaving medical information is a wake-up call for all who recognize the ramifications of this latest act of FDA malfeasance.

What the FDA Allows You to Hear

The number of people logging on to the website of Diamond Foods was miniscule. I suspect that before the FDA took this draconian action, hardly anyone even knew this website existed.

What the public hears loud and clear, however, are endless advertisements for artery-clogging junk foods. Fast food chains relentlessly promote their 99-cent double-cheese burger as being bigger than their rivals. These advertisements induce many consumers to salivate for these toxic calories that are a contributing cause of coronary artery disease. Yet the FDA does not utter a peep in suggesting that their advertising be curtailed.

On the contrary, the FDA has issued waves of warning letters to companies making foods (pomegranate juice, green tea, and walnuts) that protect against atherosclerosis.1,32-36 The FDA is blatantly demanding that these companies stop informing the public about the scientifically validated health benefits these foods provide.
The FDA obviously does not want the public to discover that they can reduce their risk of age-related disease by consuming healthy foods. They prefer consumers only learn about mass-marketed garbage foods that shorten life span by increasing degenerative disease risk.

FDA Allows Potato Chips to Be Advertised as “Heart Healthy”

Frito-Lay® is a subsidiary of the PepsiCo, Inc., makers of Pepsi-Cola. Frito-Lay® sells $12 billion a year of products that include:
Lays® Potato Chips Doritos® Tostitos® Cheetos® Fritos®

You might not associate these mostly-fried snack foods as being good for you, but the FDA has no problem allowing the Frito-Lay® website to state the following:
“Frito-Lay® snacks start with real farm-grown ingredients. You might be surprised at how much good stuff goes into your favorite snack. Good stuff like potatoes, which naturally contain vitamin C and essential minerals. Or corn, one of the world’s most popular grains, packed with thiamin, vitamin B6, and phosphorous—all necessary for healthy bones, teeth, nerves and muscles.

“And it’s not just the obvious ingredients. Our all-natural sunflower, corn and soybean oils contain good polyunsaturated and monounsaturated fats, which help lower total and LDL ‘bad’ cholesterol and maintain HDL ‘good’ cholesterol levels, which can support a healthy heart. Even salt, when eaten in moderation as part of a balanced diet, is essential for the body.”37

Wow! Based on what Frito-Lay® is allowed to state, it sounds like we should be living on these snacks. Who would want to ingest walnuts, pomegranate, or green tea (which the FDA is attacking) when these fat calorie-laden, mostly-fried carbohydrates are so widely available?

According to the Frito Lay® website, Lays® potato chips are “heart healthy” because the level of saturated fat was reduced and replaced with sunflower oil.38 Scientific studies do show that when a polyunsaturated fat (like sunflower oil) is substituted for saturated fat, favorable changes in blood cholesterol occur.39

Fatally omitted from the Frito-Lay® website is the fact that sunflower oil supplies lots of omega-6 fats, but no omega-3s.40 The American diet already contains too many omega-6 fats and woefully inadequate omega-3s.

Excess omega-6 fats in the diet in the absence of adequate omega-3s produce devastating effects, including the production of pro-inflammatory compounds that contribute to virtually every age-related disease, including atherosclerosis.41-45

For the FDA to allow Frito-Lay® to pretend there are heart benefits to ingesting their unhealthy snack products, while censoring the ability of walnut companies to make scientifically substantiated claims, is tantamount to treason against the health of the American public.

Don’t Forget the Acrylamides

When carbohydrate foods are cooked at high temperature (as occurs when potatoes are fried in sunflower oil to make potato chips), a toxic compound called acrylamide is formed.46

According to the National Cancer Institute, “acrylamide is considered to be a mutagen and a probable human carcinogen, based mainly on studies in laboratory animals. Scientists do not yet know with any certainty whether the levels of acrylamide typically found in some foods pose a health risk for humans.”47

In response to these kinds of concerns, the FDA funded a massive study to ascertain the acrylamide content of various foods. The FDA found that potato chips and other fried carbohydrate foods were especially high in acrylamides.48

The FDA, however, has not stopped companies selling high acrylamide–containing fried carbohydrates from promoting these foods as “healthy.”

Pharmaceutical Companies Benefit From FDA’s Misdeeds

As the aging population develops coronary atherosclerosis, pharmaceutical companies stand to reap tens of billions of dollars each year in profits. An obstacle standing in their way is scientific evidence showing that a healthy diet can prevent heart disease from developing in many people.

It is thus in the economic interests of pharmaceutical giants that the FDA forcibly censor the ability of companies making heart healthy foods to inform the public of the underlying science. The fewer consumers who know the facts about walnuts, pomegranate, and green tea, the greater the demand will be for expensive cardiac drugs, stents, and coronary bypass procedures.

Once again, the FDA overtly functions to enrich Big Pharma, while the public shoulders the financial burden of today’s health care cost crisis.

In this particular case, however, processed food companies also stand to profit from the FDA’s attacks on healthy foods as competition from walnut growers is stifled.

FDA/FTC Wants More Control Over What You Are Allowed to Learn

The FDA and FTC (Federal Trade Commission) are proposing new regulations that will stifle the ability of natural food companies to disseminate scientific research findings.
One proposal being discussed within the FTC would require that supplement companies conduct studies analogous to what the FDA requires to approve new drugs. In a perfect world, Life Extension would agree with some of the FTC’s objectives. As far as we are concerned, the more scientific research to validate a health claim, the better.

The reality is that natural foods do not carry high prescription drug price markups, so it would be economically impossible to conduct the same kinds of voluminous clinical studies as pharmaceutical companies do. As readers of this column know, many of the clinical studies the FDA relies on to approve new drugs are fraudulent to begin with. So even if it were feasible to conduct more clinical research on foods and supplements, that still does not guarantee the precise accuracy the FTC is seeking.

If these agency proposals are enacted, consumers will be barred from learning about new ways to protect their health until a food or nutrient meets stringent new requirements. A look at the warning letter the FDA sent to Diamond Foods is a frightening example of how scientific information can be harshly censored by unelected bureaucrats.

If anyone still thinks that federal agencies like the FDA protect the public, this proclamation that healthy foods are illegal drugs exposes the government’s sordid charade.

 

[munchie64]

I was originally going to say this:

... but after skimming through I decided to read the whole thing, and now my reaction is this:

Seriously... What? Very odd indeed.

 

[Duke]

The only "nuts" are the people at the FDA who posted such comments or article/s.

 

[Manic]

I remember the FDA causing a fuss over Cheerios cereal as well. The cereal was advertised as helping lower cholesterol, and the FDA threatened to label it as a drug. I'm starting to get the impression that there are a few underhanded companies throwing money at the FDA to either besmirch the competition or exaggerate the benefits of their junk food.

 

[Hotwire]

I remember the FDA causing a fuss over Cheerios cereal as well. The cereal was advertised as helping lower cholesterol, and the FDA threatened to label it as a drug. I'm starting to get the impression that there are a few underhanded companies throwing money at the FDA to either besmirch the competition or exaggerate the benefits of their junk food.

Just a few?

 

[SuperFerret]

That's the thing, if you want to promote your product as having some sort of health benefit beyond "food", it's likely going to be classified as a drug. Even nutritional supplements are considered "drugs".

It's all wishy-washy due to inconsistent terminology.

 

[Manic]

That strikes me as being the FTC's territory, though. The FDA should classify this stuff as either food or drugs based on the facts, while the FTC should regulate how it's promoted.

 

[Destructus86]

I'm surprised the FDA bothered to even look into things like this...what with them being so busy being bought off by every other company out there.

 

[Shemtov]

This is violating Diamond Foods Free Speech rights.

 

[Spider-Vader]

Why is our money getting wasted on stupid research like this again?

 

[chaseter]

Because it's the government that people wants more of.

 

[bored]

If you're going to market something, even something as mundane as walnuts, as having a particular health benefit, it's going to be scrutinized. They need to deal with it.

 

[THE MR. TERRIFIC]

I remember the FDA causing a fuss over Cheerios cereal as well. The cereal was advertised as helping lower cholesterol, and the FDA threatened to label it as a drug. I'm starting to get the impression that there are a few underhanded companies throwing money at the FDA to either besmirch the competition or exaggerate the benefits of their junk food.

This!

 

[BrollySupersj]

Why is our money getting wasted on stupid research like this again?

Because interstellar travel is lame.

 

[Bim]

Well apparently walnuts are bad, but pesticides are good! lol

http://gma.yahoo.com/orange-juice-safe-fda-says-carbendazim-causes-no-084405730--abc-news.html

Is Your Orange Juice Safe?: FDA Says Carbendazim Causes No Safety Concern

Low levels of a banned pesticide found in orange juice imported from Brazil is safe for sale in the domestic supply, says the Food and Drug Administration after conducting new tests.

The juice, which is stored in huge, three-story high tanks in Florida, is tainted with the fungicide carbendazim, and will soon reach American grocery stores.

"In this case, we've been really cautious in working with EPA to insure that these residues are posing no safety concern," Michael Taylor, deputy director of the FDA, said Thursday.

The FDA has said that the juice is entirely safe to drink and that the amount of the fungicide in the contaminated OJ is far below unsafe levels. To test positive for the pesticide, orange juice samples had to contain at least 10 parts per billion of the pesticide.

Carbendazim has been found to cause birth defects in rodents and some chromosome problems in human cells in laboratories. However, it hasn't been found to have any health effects for humans. Carbendazim is a pesticide used to kill fungus and fungal spores. It is not approved for use on oranges in the U.S., but is lawful in other countries.

Studies show no risks of consuming carbendazim at up to 80 parts per billion, and that actual levels of danger are thousands of times higher, the Environmental Protection Agency said.

"FDA is confident that orange juice in the United States may be consumed without concerns about its safety due to the possible presence of such residues," said a statement on the agency's website.

News that government inspectors have found the banned fungicide in the domestic supply sounds alarming to some shoppers, who have already wary of drinking processed juice.

"I'll probably squeeze my own a little bit more and probably not drink as much bottled orange juice," one shopper told ABC News. "We haven't purchased orange juice since these stories came out."

Still the FDA, which began testing all orange juice on U.S. shelves and entering the country earlier this month, maintains that no serious threat is posed and that neither the contaminated OJ held at the border, nor the juice in the contaminated tanks, is dangerous.

"We think it would be unduly disruptive of the food supply to try to withdraw that product from the market," Taylor said.

But critics say the orange juice contamination does show the system is vulnerable to imported food supplies.

"For this orange juice, we're really lucky," Caroline Smith Dewall of the Center for Science in the Public Interest said. "The real concern is the next hazard that's going to enter through imported products."

The American juice processors are not being asked to clean the tanks, as the FDA says it will let the fungicide wash its way out of the storage system, along with the orange concentrate and onto store shelves over next few weeks.

 

[Destructus86]

the FDA swings to whatever direction they are paid from.