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FDA Says Walnuts Are Illegal Drugs

By Faloon

Faloon

Faloon

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

What the FDA Allows You to Hear

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

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

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

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.

Chilling Effect on Innovation

Chilling Effect on Innovation

Headquartered in Stockton, California, Diamond Foods is a processor and

marketer of nuts, with distribution in over 80% of US supermarkets. Most

of Diamond’s 1,700 walnut growers are family farmers with orchards in

the heartland of California’s Central Valley. Their association with

Diamond guarantees a market for their crops and provides the company

with high-quality walnuts.

In response to independent scientific studies validating the health

benefits of walnuts, Diamond Foods made financial investments to educate

the public and supply them with walnuts. With one misguided letter

issued by the FDA, all of Diamond Foods’s good work was undone.

This kind of bureaucratic tyranny sends a strong signal to the food

industry not to innovate in a way that informs the public about foods

that protect against disease. While consumers increasingly reach for

healthier dietary choices, the federal government wants to deny food

companies the ability to convey findings from scientific studies about

their products.

Companies That Sell Healthy Foods Try to Fight Back

Companies That Sell Healthy Foods Try to Fight Back

The combined sales of the companies attacked by the FDA are only a

fraction of those of food giant Frito-Lay®. Yet some of these companies

are fighting back against the FDA’s absurd position that it is illegal

to disseminate scientific research showing the favorable effects these

foods produce in the body. The makers of pomegranate juice, for example,

have sued the FTC for censoring their First Amendment right to

communicate scientific information to the public.

As a consumer, you should be outraged that disease-promoting foods are

protected by the federal government, while nutritious foods are

censored. There is no scientific rationale for the FDA to do this. On

the contrary, the dangerous foods ubiquitously advertised in the media

are replacing cigarettes as the leading killers in modern society.

The federal government is heavily lobbied by companies selling processed

foods. As Life Extension revealed long ago, an insidious activity of

lobbyists is to incite federal agencies and prosecutors to eliminate

free competition in the marketplace.

The simple fact is that walnuts are healthy to eat, while carbohydrates

fried in fat are not. The FDA permits companies selling

disease-promoting foods to deceive the public, while it suppresses the

dissemination of peer-reviewed scientific information about healthy foods.

Now the Good News…

Now the Good News…

On April 5, 2011, a bipartisan bill was introduced into the House of

Representatives called the Free Speech About Science Act (H.R. 1364).

This landmark legislation protects basic free speech rights, ends

censorship of science, and enables the natural health products community

to share peer-reviewed scientific findings with the public.

The Free Speech About Science bill has the potential to transform

medical practice by educating the public about the real science behind

natural health.

For this very reason, the bill will encounter opposition. It will be

opposed by the FDA since it restricts their ability to censor the

dissemination of published scientific data. It will be opposed by drug

companies fearing competition from natural health approaches based on

diet, dietary supplements, and lifestyle.

The public, on the other hand, wants access to credible information they

can use to make wise dietary choices. Please don’t let special interests

stop this bill.

I ask that each of you log on to our Legislative Action Website

(www.lef.org/lac) that enables you to conveniently email and ask your

Representative to co-sponsor the Free Speech About Science Act (H.R. 1364).

Passage of the Free Speech About Science Act will stop federal agencies

from squandering tax dollars censoring what you are allowed to learn

about health-promoting foods.

Our Legislative Action Website provides you direct contact with your

Representative to let them know that you want H.R. 1364 (Free Speech

About Science Act) enacted into law.

Take Action

The letter on the next page is what you can easily send to your

Representative by logging on to www.lef.org/lac.

For longer life,

For Longer Life

Faloon

“When the people fear their government, there is tyranny; when the

government fears the people, there is liberty.”

— Jefferson

http://www.lef.org/magazine/mag2011/aug2011_FDA-Says-Walnuts-Are-Illegal-Drugs_0\

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