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September 2003

The White House Urges Greater Omega-3 Consumption
William Faloon

There once was a time when the U.S. Government stated that there was no relationship between dietary fat intake and artery disease. Not only did the government publish their proclamation, but enforced it at gunpoint.

The basis for censoring this dietary information was an edict by the FDA that made it illegal to even imply that fats and oils had a relationship to diseases of the heart and arteries. According to the FDA, to make any statement about fat consumption and heart attack risk constituted “misbranding,” a serious criminal offense. An excerpt of the FDA’s misguided prohibition statement appears on the next page.

How times have changed! On May 27, 2003, The White House urged health agencies of government to encourage Americans to increase their consumption of foods rich in omega-3 fatty acids and decrease their intake of trans fatty acids. The release issued by the Executive Office of The President stated:

“Health researchers have found that Americans can significantly reduce the risk of heart disease with a modest change in their diets. The government should make this life-saving information as widely available as possible.”

A basis for The White House’s initiative are new guidelines by the American Heart Association that recommends consuming cold-water fish at least twice a week and other oils and food sources high in omega-3 fatty acids. The Office of The President also cited the “growing body of scientific evidence, both experimental and epidemiological, that suggests that consumption of trans fatty acids increases the risk of coronary heart disease.”

The FDA’s Previous Ban On Dietary Fat and Heart Disease Claims

“The advisability of making extensive changes in the nature of the dietary fat intake of the people of this country has not been demonstrated. It is therefore the opinion of the Food and Drug Administration that any claim, direct or implied, in the labeling of fats and oils or other fatty substances offered to the general public that they will prevent, mitigate or cure diseases of the heart or arteries is false or misleading, and constitutes misbranding within the meaning of the Federal Food, Drug and Cosmetic Act.”*

*Federal Register: December 12, 1959. Reaffirmed by the FDA in the Federal Register: May 18, 1965.

The political battle over what Americans eat
Junk food is big business in the United States. Historically, processed food companies used their political clout to persuade the Federal government to defend the safety of dangerous food products. The medical costs of treating diseases caused by poor diet have become so staggering, however, that even The White House is recommending that Americans eat healthier.

For nearly two decades, the FDA protected the economic interests of companies selling high fat and high cholesterol foods by making it illegal to promote healthy diet as a way of preventing heart disease. Heart attack rates were three times higher in the 1950’s than in the 1990’s. The FDA’s censorship of healthy dietary information caused millions of Americans to unnecessarily succumb to cardiovascular and other diseases.

For instance, it was long ago established that consumption of cold-water fish reduced the risk of heart attack.1 In fact, just two to three servings of fish a week can protect against many diseases including, arthritis, stroke, certain cancers and a host of inflammatory-related disorders.2-9

When scientists sought to discover what components of fish were responsible for preventing heart attacks, they found that the oil played a critical role. Cold-water fish oil is high in omega-3 fatty acids that function in multiple ways to reduce cardiovascular disease risk.10

Based on the published scientific evidence about fish oil, a lawsuit was filed in 1994 by Durk Pearson and Sandy Shaw against the FDA seeking to force the agency to allow the following health claim:

"Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.”

The FDA rejected this one sentence claim and a multi-year litigation battle erupted.

In their lawsuit, Durk and Sandy pointed out that consumers would benefit by learning of the value of fish oil in protecting against heart disease. On a legal basis, it was argued that the FDA lacked the constitutional authority to ban this truthful and non-misleading health claim.

The FDA contended that this health claim was not adequately backed by scientific studies and that the agency had the legal discretion to ban these kinds of health claims.

Seven years of expensive litigation ensued as the FDA asserted that it had the sole authority to dictate what Americans could read on the label of fish oil supplements. After an onslaught of irrefutable scientific evidence was presented, including articles published in the most prestigious scientific journals in the world, the FDA capitulated and said it would permit the following claim:

“Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease. FDA evaluated the data and determined that although there is scientific evidence supporting the claim, the evidence is not conclusive.”

The White House’s new position on heart disease
The Office of The President states in its official position paper, “Since coronary heart disease kills over 500,000 Americans each year, even a small improvement in dietary habits could save thousands of lives.”

The Life Extension Foundation believes The White House is understating the number of lives that could be saved. According to an article published in The Lancet,3 men who consume the most trans fatty acids have twice the risk of developing heart disease compared to their counterparts who consumed the least. The American Heart Association recently published a study of 11,323 heart attack patients showing that those who took a 1000 mg fish oil supplement every day were 45% less likely to be dead at the end of 3.5 years.

The White House is not emphasizing the enormity of human suffering that would be eliminated if Americans were better educated about what foods they should eat. While it is true that 500,000 Americans die from heart disease annually, there are about one million people who suffer heart attacks each year. The economic costs of open-heart surgeries, cardiac rehabilitation, cardiac drugs and emergency room visits is bankrupting the health care system of this nation. Aggressive government action to better educate consumers about healthier diets could dramatically postpone the date when Medicare becomes insolvent.

Approximately 300,000 of the annual heart attack fatalities are of the “sudden death” variety. The omega-3 fatty acids (found in cold water fish oils) are particularly protective against these “sudden death” heart attacks. Studies show that as few as two fish meals a week reduce heart attack risk by half.11

If all Americans regularly took fish oil supplements or ate about two cold-water fishmeals a week, it could prevent about 150,000 sudden death heart attacks a year. During the seven years it took to litigate the fish oil health claim against the FDA, over one million preventable sudden death heart attacks were suffered by American citizens.

FDA Approval Sought For New Omega-3/Heart Disease Health Claim

Based on overwhelming documentation that greater consumption of omega-3 fatty acids reduce cardiovascular disease risk, Life Extension Buyers Club and Wellness Lifestyles, Inc. filed a new health claim petition with the FDA. The petition urges the FDA to reconsider the currently permitted health claim for omega-3 fatty acids and coronary heart disease risk. The FDA says the scientific evidence regarding omega-3 consumption and heart disease is “not conclusive.” The petitioners argue that there is sufficient published evidence to allow the following new claim: 

“Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.”

To substantiate this position, attorney Jonathan Emord filed a massive document that enumerates the scientific studies backing the benefits of omega-3 fatty acids, argues the Constitutional right to disseminate this information and calculates how many American lives are being lost because the FDA has denied this claim. Review this enormous petition filed on June 23, 2003.

FDA reform urgently needed
The cardio-protective effects of cold-water fish have been known to scientists for over 20 years,12 yet the FDA actively tried to censor this information from the public. Clearly the regulatory system in this country has to be changed, as the number of years of life lost on the fish oil issue alone is incalculable.

The effects of fish oil on cardiovascular health have been consistently unambiguous, i.e., those who eat cold-water fish have fewer heart attacks. The FDA took this easy-to-understand fact and turned it into a complex legal morass that took seven years to resolve.

There are many promising lifesaving drugs bogged down in the FDA’s regulatory quagmire. The safety and efficacy of these drugs is far more difficult to comprehend than ascertaining whether fish oil is beneficial. Yet the FDA still retains absolute authority to decide if and when these drugs will ever be approved. Meanwhile, those whose lives could be saved by these yet-to-be-approved therapies perish every day.

The chilling effects of censorship
Scientific disagreement can only be resolved when sufficient evidence manifests to prove one side right (and the other wrong). In the case of dietary fat and heart attack risk, history has proven the FDA absolutely wrong. There is nothing immoral about being wrong about new scientific concepts, as no one can expect perfection in these novel areas.

What is genocidal about the FDA being wrong, however, is their police-state power to suppress opposition. Those who don’t agree with the FDA are subject to criminal indictment, forfeiture and imprisonment. This kind of draconian authority has a chilling effect on the dissemination and implementation of new scientific principles. Under today’s totalitarian system, creative solutions to life-threatening diseases are stifled not only because of direct FDA actions, but also by the fear of becoming the next victim of a FDA witch-hunt.