Friday November 03 12:37 PM EST
FDA: Fish Oil (Sort Of) OK
By Adam Marcus
HealthScout Reporter


THURSDAY, Nov. 2 (HealthScout) -- The U.S. Food and Drug Administration thinks the fatty acids found in such foods as fish just might help prevent heart disease, but the agency is not absolutely sure.

This means that the FDA will let makers of omega-3 supplements tout their products as something that may protect the heart and vessels, but the labels and ads can't say it definitely does so.

At issue are polyunsaturated fatty acids, or PUFAs, like the omega-3 fatty acids found in plant oils such as flax seed and fish such as salmon, tuna and mackerel. Studies have shown that eating diets high in these foods can markedly lower total cholesterol levels, which in turn lowers the risk of coronary heart disease.

But the FDA, in its announcement this week, says the evidence for making such a claim is divided. It will therefore allow supplement companies to market their products with the following -- or similar -- qualifications:

"The scientific evidence about whether omega-3 fatty acids may reduce the risk of coronary heart disease (CHD) is suggestive, but not conclusive. Studies in the general population have looked at diets containing fish, and it is not known whether diets or omega-3 fatty acids in fish may have a possible effect on a reduced risk of CHD. It is not known what effect omega-3 fatty acids may or may not have on risk of CHD in the general population."

The American Heart Association's latest guidelines recommend that people consume at least two 4-ounce servings of fish a week. The AHA is not yet willing to say that it's the omega-3 fatty acids in fish that protect the heart. But Dr. Ronald Krauss, head of the department of molecular medicine at the University of California, Berkeley and an author of the latest AHA guidelines, says the possibility is worth exploring.

The FDA's equivocation in its latest ruling "is an absolutely fair reading of the science on this topic. I would agree that this is still a relatively incomplete story," says Krauss.

The FDA's ruling also put the brakes on more-is-better advertising. Supplement makers can't say that taking more than 2 grams per day of omega-3 will intensify the heart benefits.

Jonathan Emord, a Washington, D.C., lawyer who had sued the FDA on behalf of the supplement industry to act on PUFAs, says the agency's decision is imperfect but "adequate."

"Conclusive evidence is rarely ever found with nutrition studies," Emord says. "We accept it as a useful claim. It's not the best, but it's certainly not the worst."

Emord did criticize the claim's wording, which he said was redundant, too long and ultimately confusing for consumers. "I hope they would consider requests by the industry to modify the language," he says.

Al Czap, president of Thorne Research, a Dover, Idaho-based company that markets supplements to health-care professionals, agrees that the labeling caveats suggested by the FDA are onerous. The typical fish oil supplement bottle can handle a 12-word label, he says, but the FDA's proposed claim runs more than 80 words.

Omega-3 fatty acids were first found to protect the heart in Eskimos, whose diet consists largely of oil-rich fish. But subsequent research has shown PUFAs to reduce the risk of heart disease and strokes in people who consume more modest amounts of seafood.

For example, an Italian study last year reported that people with a history of heart attacks who ate at least a gram a day of fish oil -- about 3.5 ounces of fish -- for 3½ years had a 15 percent lower risk of death, heart attacks and strokes than those who did not.

Dr. William Connor, an expert in omega-3 acids at the Oregon Health Sciences University in Portland, says the molecules appear to work in several ways to promote good heart health. They reduce the ability of platelets in blood to clump together and thus stall the formation of clots; they lower the blood level of triglycerides, an important blood fat; and they help restore normal muscle and electrical function in heart muscle.

These desirable effects come both from fish meat or dietary supplements, notes Connor, who took part in a recent conference with reporters to discuss omega-3 fatty acids. Popular fish oil supplements include EPA and DHA.

However, Penny Kris-Etherton, a Pennsylvania State University nutritionist who also participated in the press conference, says the typical American diet is very low in omega-3 acids. Heart experts recommend eating at least three meals a week of fatty fish like mackerel, salmon or herring -- but most Americans consume only one fish meal a week.

What To Do

Eating several fish meals a week will not only help you get the benefits of omega-3 fatty acids, experts say, but it will also eliminate the less healthful saturated fats that come from red meat.

For more on fish oils, try the American Heart Association. The AHA also has comprehensive recommendations for a healthful diet. Also, try the Mayo Clinic and, for a survey of American eating habits, see The American Dietetic Association.

In addition, take a look at previous HealthScout stories on omega-3 fatty acids.


http://dailynews.yahoo.com/h/hsn/20...rt_of_ok_1.html

Hmmm
 

My take on the issue of political approval of health claims is that, as always, it is financially motivated. Big pharmaceutical conglomerates release new drugs every week, with clinical success rates often less than 10%, but billions of $$ invested. Natural treatments of course, can't be patented, so not much profit to be made. Yet gov't and public health agencies expect 100% proof of efficacy before official endorsement is given. Sickening, isn't it?

Einstein's theory of relativity has NEVER been proven by the standard "scientific" requirement of double-blind, peer-reviewed trial. That's why it's still called a theory. But we know that it works. Otherwise, the NASA space program would never have gotten off the ground!!

And in the face of mounting evidence that low-carb, high protein diets are effective at reducing many health risks, gov'ts and agencies still preach and endorse the old LOWFAT way, with 95% failure rate. Why?? $$$$$$$$$$$$

Just my opinion, of course.
Doreen

Re: Hmmm
 

What's interesting as well is endoresing the labeling of sacharine, aspartame and sucralose as "sweetners", while natural products like stevia, just a pure plant extract CANNOT be labeled as a sweetner even thought it's sweeter than sugar. The sugar loby is quite powerful, and often gets what it wants from the gov.

Wa'il

$$$$$$$
 

$$$$$$$$$$$$ etc. . . ..