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Question Marks Over GRAS Status

Lurking in the background of industry hype for soy is the nagging question of whether it's even legal to add soy protein isolate to food. All food additives not in common use prior to 1958, including casein protein from milk, must have GRAS (Generally Recognized As Safe) status. In 1972, the Nixon administration directed a re-examination of substances believed to be GRAS, in the light of any scientific information then available.

This re-examination included casein protein that became codified as GRAS in 1978. In 1974, the FDA obtained a literature review of soy protein because, as soy protein had not been used in food until 1959 and was not even in common use in the early 1970s, it was not eligible to have its GRAS status grandfathered under the provisions of the Food, Drug and Cosmetic Act.71

The scientific literature up to 1974 recognized many antinutrients in factory-made soy protein, including trypsin inhibitors, phytic acid and genistein. But the FDA literature review dismissed discussion of adverse impacts, with the statement that it was important for "adequate processing" to remove them.

Genistein could be removed with an alcohol wash, but it was an expensive procedure that processors avoided. Later studies determined that trypsin inhibitor content could be removed only with long periods of heat and pressure, but the FDA has imposed no requirements for manufacturers to do so.

The FDA was more concerned with toxins formed during processing, specifically nitrites and lysinoalanine.72 Even at low levels of consumption - averaging one-third of a gram per day at the time - the presence of these carcinogens was considered too great a threat to public health to allow GRAS status.

Soy protein did have approval for use as a binder in cardboard boxes, and this approval was allowed to continue, as researchers considered that migration of nitrites from the box into the food contents would be too small to constitute a cancer risk. FDA officials called for safety specifications and monitoring procedures before granting of GRAS status for food.

These were never performed. To this day, use of soy protein is codified as GRAS only for this limited industrial use as a cardboard binder. This means that soy protein must be subject to premarket approval procedures each time manufacturers intend to use it as a food or add it to a food.

Soy protein was introduced into infant formula in the early 1960s. It was a new product with no history of any use at all. As soy protein did not have GRAS status, premarket approval was required. This was not and still has not been granted. The key ingredient of soy infant formula is not recognized as safe.

The Next Asbestos?

"Against the backdrop of widespread praise...there is growing suspicion that soy - despite its undisputed benefits - may pose some health hazards," writes Marian Burros, a leading food writer for the New York Times. More than any other writer, Ms Burros's endorsement of a low-fat, largely vegetarian diet has herded Americans into supermarket aisles featuring soy foods.

Yet her January 26, 2000 article, "Doubts Cloud Rosy News on Soy", contains the following alarming statement: "Not one of the 18 scientists interviewed for this column was willing to say that taking isoflavones was risk free." Ms Burros did not enumerate the risks, nor did she mention that the recommended 25 daily grams of soy protein contain enough isoflavones to cause problems in sensitive individuals, but it was evident that the industry had recognized the need to cover itself.

Because the industry is extremely exposed...contingency lawyers will soon discover that the number of potential plaintiffs can be counted in the millions and the pockets are very, very deep. Juries will hear something like the following: "The industry has known for years that soy contains many toxins.

At first they told the public that the toxins were removed by processing. When it became apparent that processing could not get rid of them, they claimed that these substances were beneficial. Your government granted a health claim to a substance that is poisonous, and the industry lied to the public to sell more soy."

The "industry" includes merchants, manufacturers, scientists, publicists, bureaucrats, former bond financiers, food writers, vitamin companies and retail stores. Farmers will probably escape because they were duped like the rest of us. But they need to find something else to grow before the soy bubble bursts and the market collapses: grass-fed livestock, designer vegetables...or hemp to make paper for thousands and thousands of legal briefs.

Extracted from Nexus Magazine, Volume 7, Number 3 (April-May 2000)

About the Authors:

Sally Fallon is the author of Nourishing Traditions: The Cookbook that Challenges Politically Correct Nutrition and the Diet Dictocrats (1999, 2nd edition, New Trends Publishing, tel +1 877 707 1776 or +1 219 268 2601) and President of the Weston A. Price Foundation, Washington, DC (www.WestonAPrice.org)

Mary G. Enig, Ph.D., a nutritionist widely known for her research on the nutritional aspects of fats and oils, is a consultant, clinician, and the Director of the Nutritional Sciences Division of Enig Associates, Inc., Silver Spring, Maryland.

She received her PhD in Nutritional Sciences from the University of Maryland, College Park in 1984, taught a graduate course in nutrient-drug interactions for the University's Graduate Program in Nutritional Sciences, and held a Faculty Research Associateship from 1984 through 1991 with the Lipids Research Group in the Department of Chemistry and Biochemistry.

Dr. Enig is a Fellow of the American College of Nutrition, and a member of the American Institute of Nutrition. Her many years of experience as a "bench chemist" in the analysis of food fats and oils, provides a foundation for her active roles in food labeling and composition issues at the federal and state levels.

Dr. Enig is a Consulting Editor to the "Journal of the American College of Nutrition" and formerly served as a Contributing Editor to "Clinical Nutrition." She has published 14 scientific papers on the subject of food fats and oils, several chapters on nutrition for books, and presented over 35 scientific papers on food and nutrition topics.

She is the President of the Maryland Nutritionists Association, past President of the Coalition of Nutritionists of Maryland and was appointed by the Governor in 1986 to the Maryland State Advisory Council on Nutrition and served as the Chairman of the Health Subcommittee until the Council was disbanded in 1988.

COMMENT:

Sally Fallon and Dr. Enig are to be highly commended for this much needed soy update. Together they have compiled the most definitive document to date on why one should avoid soy. This is a MAJOR work and I am hoping to promote it for the national media attention that it deserves.

Another article on How Much Soy Asians Actually Eat

ENDNOTES:

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