The Weston A. Price Foundation has submitted a citizen petition asking FDA to revoke its regulation approving a health claim for soy protein and coronary heart disease.According to the petition, in light of studies published since the regulation was issued in 1999, “[t]he totality of the scientific evidence on soy protein and heart disease is contradictory and inconsistent” and no longer supports the claim approved by FDA.In addition, the petition questions whether soy protein isolates are GRAS.The citizen petition does not acknowledge that FDA already has announcedits intention to reconsider the health claim for soy protein.That claim was approved prior to the advent of qualified health claims.Thus, if the current supporting evidence does not meet the standard of significant scientific agreement, a qualifying statement could be added to the existing claim to more accurately reflect the strength of the supporting evidence.
In support of the requested relief, the petition cites a 2006 Science Advisory on Soy Protein, Isoflavones, and Cardiovascular Health issued by the Nutrition Committee of the American Heart Association, which concludes that “the direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best. Soy protein or isoflavones have not been shown to improve vasomotor symptoms of menopause, and results are mixed with regard to the slowing of postmenopausal bone loss. The efficacy and safety of soy isoflavones for preventing or treating cancer of the breast, endometrium, and prostate are not established; evidence from clinical trials is meager and cautionary with regard to a possible adverse effect. For this reason, use of isoflavone supplements in food or pills is not recommended.”However, the AGA science advisory also concludes that “soy products such as tofu, soy butter, soy nuts, or some soy burgers should be beneficial to cardiovascular and overall health because of their high content of polyunsaturated fats, fiber, vitamins, and minerals and low content of saturated fat. Using these and other soy foods to replace foods high in animal protein that contain saturated fat and cholesterol may confer benefits to cardiovascular health.”