Dr. Johanna Budwig’s Healing Diet & Protocol

"Qualified Health Claim" for omega-3 essential fatty acids

FDA announcement re EPA and DHA

This page discusses the encouraging "Qualified Health Claim" status for omega-3 EFAs granted by the FDA in 2004.

The following is excerpted by HealingCancerNaturally.com from U.S. Food and Drug Administration, P04-89, September 8, 2004 formerly published at www.fda.gov/bbs/topics/news/2004/new01115.html

The Food and Drug Administration (FDA) today announced the availability of a qualified health claim for reduced risk of coronary heart disease (CHD) on conventional foods that contain eiscosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids.

Typically, EPA and DHA omega-3 fatty acids are contained in oily fish, such as salmon, lake trout, tuna and herring. These fatty acids are not essential to the diet; however, scientific evidence indicates that these fatty acids may be beneficial in reducing CHD.

"Coronary heart disease is a significant health problem that causes 500,000 deaths annually in the United States," said Dr. Lester M. Crawford, Acting FDA Commissioner. "This new qualified health claim for omega-3 fatty acids should help consumers as they work to improve their health by identifying foods that contain these important compounds."

A qualified health claim on a conventional food must be supported by credible scientific evidence. Based on a systematic evaluation of the available scientific data, as outlined in FDA's "Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements", FDA is announcing a qualified health claim for EPA and DHA omega-3 fatty acids. While this research is not conclusive, the FDA intends to exercise its enforcement discretion with respect to the following qualified health claim:

"Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.]

In 2000, FDA announced a similar qualified health claim for dietary supplements containing EPA and DHA omega-3 fatty acids and the reduced risk of CHD. FDA recommends that consumers not exceed more than a total of 3 grams per day of EPA and DHA omega-3 fatty acids, with no more than 2 grams per day from a dietary supplement.

The EPA and DHA omega-3 fatty acid qualified health claim is the second qualified health claim that FDA has announced for conventional food. For additional information about QHC visit: www.cfsan.fda.gov/~dms/lab-qhc.html.

Comment on Implications of "Qualified Health Claim" Status For Omega-3 EFA
by C.C., Long Beach, CA
"Most people don't fully appreciate the implications of so-called FDA Qualified Health Claim status granted to common foods. For adherents to the Budwig Diet, however, this is BIG NEWS.
In my opinion, after researching FDA actions, past and present, this seemingly innocuous announcement absolutely vindicates Dr. Budwig's work. The only problem--if indeed it can be considered a problem--is that the research done to grant QHC status to Omega-3 EFA was not done relative to cancer, nor did it highlight flaxseed as a source of Omega-3 EFA. Oh, well...Rome wasn't built in a day."

New Information On Omega-3 Fatty Acids

by Jon Barron. Excerpted from Baseline of Health newsletter, September 13 , 2004

What's the inspiration for today's newsletter? Two things.

An FDA announcement on September 8th
The results of a new medical study on Alzheimer's and Omega-3 fatty acids released on September 2nd.

The FDA Speaks Up

On September 8th, the FDA announced the availability of a new "approved" qualified health claim for Omega-3 fatty acids... as found in food.

"Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease." [Note: the Omega-3 fatty acids are DHA (Docosahexaenoic acid), EPA (Eicosapentaenoic acid), and alpha-linolenic acid (which is broken down by the body into DHA and EPA).]

Isn't that wonderful? Qualified support for something that people in the alternative health community have known conclusively for over 30 years. Who says you can't teach an old dog new tricks?

It should be noted that in 2000, the FDA announced a similar qualified health claim for dietary supplements containing Omega-3 fatty acids. What they're saying now, four years later, and I know this probably comes as a big shock to most of you, is that foods containing Omega-3 fatty acids are just as healthy as supplements that contain them.

On a more serious note, this actually is a big deal. As logically simple as it might seem, it represents a seismic position change for the FDA. As they said in their announcement, "The EPA and DHA Omega-3 fatty acid qualified health claim is the second qualified health claim that FDA has announced for conventional food." [To put it in English, the FDA is saying that this is just the 2nd time in their history that they have allowed a health claim to be made for a conventional food.]

Acknowledgement from the FDA that the phytochemicals found naturally in food actually represent healing agents with medicinal properties, is a big, big deal and represents a stunning precedent available for use in future legal battles. We're talking about legally being able to state that food is medicine!! That's huge.

On the other hand, the overall official position is still totally out to lunch when it comes to fats in general, and Omega-3 fatty acids in particular, and the importance of maintaining the proper ratio between Omega-6 and Omega-3 fatty acids. Once you get past trans fatty acids, it's that unbalanced ratio that represents the single biggest health problem that the western diet faces today -- in my humble opinion.

The Study

As reported in the September 2nd issue of Neuron, scientists from UCLA and the Laval University Medical Center in Quebec City have shown for the first time that a diet high in the Omega-3 fatty acid DHA helps protect the brain against the memory loss and cell damage caused by Alzheimer's disease. The study shows that a DHA-rich diet may lower one's risk of Alzheimer's disease and help slow progression of the disorder in its later stages. ''This is the first proof that our diets affect how our brain cells communicate with each other under the duress of Alzheimer's disease,'' said Greg Cole, senior author and a professor of neurology at the David Geffen School of Medicine at UCLA. ''We saw that a diet rich in DHA, or docosahexaenoic acid, dramatically reduces the impact of the Alzheimer's gene."

And according to Frederic Calon, a molecular endocrinology researcher at Laval and a co-author of the study, "What the public needs to take from this is that diet matters to your brain. If you have a diet that is poor in Omega-3s, that will accelerate the process of Alzheimer's, especially if you're genetically predisposed."


Before you go running out to buy DHA supplements, keep in mind that EPA is equally important. Make sure that you get a supplement that contains a balanced amount of both. The importance of supplementing with Omega-3 fatty acids is only partially related to the value of the Omega-3s themselves. The ratio of Omega-6 to Omega-3 (although not addressed by either the FDA or the Study) is even more important. In current western diets it runs as high as 30:1 in favor of Omega-6. Ideally, it should be 1:1. Bottom line: as you supplement with Omega-3 fatty acids, it is vital that you also cut way back on Omega-6 fatty acids that now so dominate the western diet. Sources of Omega-6s include:

  • Virtually every bottled oil that you buy in the supermarket other than olive oil
  • Virtually every bottled salad dressing that you buy
  • Virtually every processed food that you buy
  • Virtually all fried food that you eat (unless it's cooked in lard or hydrogenated oil)
  • Virtually all of the grain-fed beef and poultry that you buy. (The animals pick up the Omega-6s from the grains they eat and store it in their flesh.
    Grass-fed beef on the other hand is low in omega-6 fatty acids.

Sources of omega-3 fatty acids include cold-water fish, like salmon, halibut, mackerel, sardines and herring. These fish consume algae, which is high in DHA. Unfortunately, these fish also absorb significant amounts of mercury, dioxin, PCP and heavy metals. A less risky strategy is to consume fish oil or purified DHA/EPA supplements made from algae. Another option includes omega-3-rich eggs laid by chickens that eat supplemented feed. And still another option is flaxseed and/or oil, which contains alpha-linolenic acid (not to mention cancer preventing lignans), which is converted by the body into DHA and EPA.

And, please while focusing on omega-3 fatty acids, don't forget the importance of monosaturated fats (as found in olive oil) and lauric acid (as found in virgin coconut oil).

(c) 2004 by The Baseline of Health Foundation.

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