Sally Fallon & Mary G. Enig, Ph.D.

FDA Health Claim Challenged

On October 25, 1999 the US Food and Drug Administration (FDA) decided to allow a health claim for products "low in saturated fat and cholesterol" that contain 6.25 grams of soy protein per serving.

Breakfast cereals, baked goods, convenience food, smoothie mixes and meat substitutes could now be sold with labels touting benefits to cardiovascular health, as long as these products contained one heaping teaspoon of soy protein per 100-gram serving.

The best marketing strategy for a product that is inherently unhealthy is, of course, a health claim.

"The road to FDA approval," writes a soy apologist, "was long and demanding, consisting of a detailed review of human clinical data collected from more than 40 scientific studies conducted over the last 20 years.

Soy protein was found to be one of the rare foods that had sufficient scientific evidence not only to qualify for an FDA health claim proposal but to ultimately pass the rigorous approval process."

The "long and demanding" road to FDA approval actually took a few unexpected turns.

The original petition, submitted by Protein Technology International, requested a health claim for isoflavones, the estrogen-like compounds found plentifully in soybeans, based on assertions that "only soy protein that has been processed in a manner in which isoflavones are retained will result in cholesterol lowering".

In 1998, the FDA made the unprecedented move of rewriting PTI's petition, removing any reference to the phyto-estrogens and substituting a claim for soy protein - a move that was in direct contradiction to the agency's regulations.

The FDA is authorized to make rulings only on substances presented by petition.

The abrupt change in direction was no doubt due to the fact that a number of researchers, including scientists employed by the US Government, submitted documents indicating that isoflavones are toxic.

The FDA had also received, early in 1998, the final British Government report on phytoestrogens, which failed to find much evidence of benefit and warned against potential adverse effects.

Even with the change to soy protein isolate, FDA bureaucrats engaged in the "rigorous approval process" were forced to deal nimbly with concerns about mineral blocking effects, enzyme inhibitors, goitrogenicity, endocrine disruption, reproductive problems and increased allergic reactions from consumption of soy products.

One of the strongest letters of protest came from Dr Dan Sheehan and Dr Daniel Doerge, government researchers at the National Center for Toxicological Research.

Their pleas for warning labels were dismissed as unwarranted.

"Sufficient scientific evidence" of soy's cholesterol-lowering properties is drawn largely from a 1995 meta-analysis by Dr James Anderson, sponsored by Protein Technologies International and published in the New England Journal of Medicine.

A meta-analysis is a review and summary of the results of many clinical studies on the same subject. Use of meta-analyses to draw general conclusions has come under sharp criticism by members of the scientific community.

"Researchers substituting meta-analysis for more rigorous trials risk making faulty assumptions and indulging in creative accounting," says Sir John Scott, President of the Royal Society of New Zealand. "Like is not being lumped with like. Little lumps and big lumps of data are being gathered together by various groups."

There is the added temptation for researchers, particularly researchers funded by a company like Protein Technologies International, to leave out studies that would prevent the desired conclusions. Dr Anderson discarded eight studies for various reasons, leaving a remainder of twenty-nine.

The published report suggested that individuals with cholesterol levels over 250 mg/dl would experience a "significant" reduction of 7 to 20 per cent in levels of serum cholesterol if they substituted soy protein for animal protein. Cholesterol reduction was insignificant for individuals whose cholesterol was lower than 250 mg/dl.

In other words, for most of us, giving up steak and eating vegieburgers instead will not bring down blood cholesterol levels. The health claim that the FDA approved "after detailed review of human clinical data" fails to inform the consumer about these important details.

Research that ties soy to positive effects on cholesterol levels is "incredibly immature", said Ronald M. Krauss, MD, head of the Molecular Medical Research Program and Lawrence Berkeley National Laboratory.35 He might have added that studies in which cholesterol levels were lowered through either diet or drugs have consistently resulted in a greater number of deaths in the treatment groups than in controls - deaths from stroke, cancer, intestinal disorders, accident and suicide.

Cholesterol-lowering measures in the US have fuelled a $60 billion per year cholesterol-lowering industry, but have not saved us from the ravages of heart disease.

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