Table of Contents
FDA Consumer magazine
July-August 2000

Letters to the Editor

Safety of Soy

As the organization representing the infant formula industry, the International Formula Council is concerned that the FDA Consumer's discussion about potential effects of soy isoflavones on infants is unbalanced and may mislead consumers. (May-June 2000 FDA Consumer, "Soy: Health Claims for Soy Protein, Questions About Components.")

In particular, the article does not emphasize that isoflavones in soy foods are thousands of times weaker than natural estrogens. There is no reference to the fact that there is no evidence, in the millions of infants who have consumed soy formula for over 60 years, that isoflavones have any estrogenic or other adverse effects. Additionally, extensive scientific data has demonstrated that infants fed soy-based infant formulas grow and develop normally.

Also, the American Academy of Pediatrics (AAP) position statement on the use of soy infant formula was misleadingly qualified in the article. The article incorrectly paraphrases the AAP statement by stating that only "in some cases" are soy formulas appropriate for use when cow's milk is not tolerated. The AAP statement clearly states: "In term infants whose nutritional needs are not being met from maternal breast milk or cow milk-based formulas, isolated soy protein-based formulas are safe and effective alternatives to provide appropriate nutrition for normal growth and development."

An infant's health may be put at risk if parents change the feeding regimen because of unwarranted concern over the safety of soy-based infant formula.

Your article on soy spoke of the possible risks of plant estrogens, but made no mention of the carcinogenic effects of protease inhibitors found in soy. McGuinness et al. report rats fed raw soya flour develop cancer of the pancreas ("The effects of long-term feeding of soya flour on the rat pancreas," Scandinavian Journal of Gastroenterology, 1980; 15:497-502). They say that preheating the flour protected the animals, but others have said that the high heat required (130 degrees Celsius) to deactivate the carcinogenic trypsin inhibitors in soya flour denatures the soy proteins to the point that they become virtually useless. If this is so, one either chooses less heating, resulting in more surviving trypsin inhibitors, or more heating, resulting in useless protein.

Labeling Genetically Engineered Foods

FDA has stated that it doesn't have the authority to require labeling of genetically engineered food based solely on the consumer's "right-to-know." (January-February 2000 FDA Consumer, "Are Bioengineered Foods Safe?") FDA has taken this position even though the Federal Food, Drug, and Cosmetic Act says it's meant to promote honest and fair dealing in the interest of consumers. In my view, refusing to label food as genetically engineered is not honest, is not fair, and is not in the interest of consumers.

To say that genetically engineered food needn't be labeled is like saying that ignorance is better than information. The Genetically Engineered Food Right-to-Know bills now in Congress, H.R. 3377 and S. 2080, are needed to do what FDA has never done: make sure that genetically engineered food isn't imposed on people without their knowledge or consent.

Misleading Health Fraud Example

In the November-December 1999 issue of FDA Consumer, the article "How to Spot Health Fraud" used the claims of an anonymous emu oil producer as an example of health fraud.

As president of the American Emu Association, representing more than 1,000 emu producers, I know that the company making these claims is not a member of the American Emu Association and your example is certainly not representative of our industry. In fact, our producers take every precaution against making claims about any emu product. We see the claims you used--of curing a wide range of unrelated diseases--as irresponsible, and the personal testimonial about Alzheimer's disease is abhorrent to us.

Our members understand that emu oil has not been evaluated by the FDA and they cannot print unsubstantiated claims on product labels. And the board of directors of AEA continues to convey this, both verbally and in written form, to each and every new member.

Our concern is that the examples you provided your readers painted a shoddy picture of a group of hard-working and conscientious professionals and presented only a portion of the picture of this industry as it exists today.

We see the behavior of the emu products company owner you quoted as irresponsible, negligent, and definitely not representative of our industry, as your article implies. Your readers should not take your article as an indictment of our entire industry.

Correction

The chart of newly approved medical products that appeared in the May-June issue of FDA Consumer contained an incorrect statement about the uses of Vioxx (rofecoxib). The drug is approved for the treatment of osteoarthritis, not rheumatoid arthritis, and for menstrual pain and acute pain in adults.

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