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Group Files Suit Over FDA’s Claim About Soy Protein’s Effect on Heart Disease

Weston A. Price Foundation filed a lawsuit today against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia.  The lawsuit seeks to compel the FDA to provide a substantive response to the Citizen Petition filed by Weston A. Price Foundation on August 8, 2008, which challenged the FDA’s Final Rule that allows health claims to be made about soy protein’s effect on coronary heart disease. 

The FDA’s “Final Rule on Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease” (effective on October 26, 1999), allowed foods containing soy protein to make advertising and labeling claims that 25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.

In its Citizen Petition, Weston A. Price Foundation raised concerns based on the large body of scientific evidence that fails to support the soy protein health claim permitted by the FDA’s Final Rule.  The Citizen Petition also discusses scientific evidence showing that soy protein consumption may have adverse health consequences, due to the presence of antinutrients, including protease inhibitors, phytates, lectins, saponins and oxalates, as well as phytoestrogens, in soy protein.  To prevent consumers from continuing to be misled about the connection between soy protein and heart health, the Citizen Petition requested revocation of the FDA’s Final Rule.

Under FDA regulations, within 180 days of the filing of a citizen petition, the FDA is required to either approve or deny the petition, or provide a tentative response indicating why the FDA has been unable to reach a decision.  To this date, the FDA has not approved, denied, or provided a tentative response to the Citizen Petition filed by Weston A. Price Foundation in 2008.

The lawsuit today is part of Weston A. Price Foundation’s continuing effort to bring truthful information to the public to enable consumers to make informed decisions about the food they eat.  The Foundation is additionally working to end the feeding of soy to prisoners.  The Foundation currently supports a lawsuit by Illinois prisoners, who allege health problems resulting from the large amounts of soy in the meals fed to them by the state.  For more details about that lawsuit, see the Foundation’s press release at http://www.westonaprice.org/press/experts-denounce-high-soy-diet-of-illinois-prisoners-2/.

The Weston A. Price Foundation is a 501(c)(3) nutrition education foundation with the mission of disseminating accurate, science-based information on diet and health. Named after nutrition pioneer Weston A. Price, DDS, author of Nutrition and Physical Degeneration, the Washington, DC-based Foundation publishes a quarterly journal for its 15,000 members, supports 600 local chapters worldwide and hosts a yearly international conference.  The Foundation phone number is (202) 363-4394, www.westonaprice.org, info@westonaprice.org.

Chicago Conference Covers Latest Research on Natural Products for Women’s Health

By James J. Gormley

On October 20th, 2012, the Natural Health Research Institute (NHRI) held its 8th Annual NHRI Scientific Symposium, entitled, “The Effectiveness of Natural Products for Women’s Health.”

Presented by the University of Illinois (UIC) College of Pharmacy and the American Nutrition Association (ANA), the UIC College of Pharmacy auditorium was attended by a students and practicing pharmacists, nurses, chiropractors and Certified Nutrition Specialists.

The event featured a stellar line-up of world-class experts in natural products and women’s health. The speakers were:

Tori Hudson, N.D., Clinical Professor at the National College of Naturopathic Medicine and Medical Director of A Woman’s Time.

Richard B. van Breemen, Ph.D., Professor of Medicinal Chemistry & Pharmacognosy and Director of the UIC/NIH Center for Botanical Dietary Supplements Research.

Harry G. Preuss, M.D., CNS, Professor of Biochemistry, Medicine and Pathology at Georgetown University Medical Center.

Dennis B. Lubahn, Ph.D., Professor of Biochemistry & Child Health and Director of the NIH Botanical Center, University of Missouri-Columbia.

William Helferich, Ph.D., Professor of Nutrition, Diet, Women’s Health & Aging, University of Illinois at Urbana-Champaign.

Liz Lipski, Ph.D., CCN, Director of Doctoral Studies & Educational Director, Hawthorn University.

Dr. Hudson’s presentation, entitled “Evidence-based Natural Solutions to Symptoms of Perimenopause and Menopause” busted some media-fed myths regarding black cohosh, in which she detailed its strong safety record and efficacy for peri-menopause and menopause symptoms.

She also outlined the benefits of ginseng, hops, kava, kudzu, maca, red clover, Pycnogenol, Sibiric rhubarb, St. John’s wort, valerian, omega-3 fats, multi-ingredient combinations and specific treatment protocols she uses for specific symptoms.

Dr. van Breemen’s talk was entitled: “Safety and Efficacy of Botanical Dietary Supplements As Alternatives to Hormone Replacement Therapy.” His presentation detailed research into botanical alternatives to HRT, including promising studies on hops, red clover and black cohosh.

Dr. Preuss’ presentation, entititled “Managing Obesity With Natural Dietary Supplements: Lessons Learned From Clinical Research Studies,” emphasized the importance of reduced body fat, not just overall weight, in improving body composition, and looked at research into chromium, carb blockers, green tea extract, and conjugated linoleic acid.

Dr. Lubahn’s talk was entitled “Using Botanicals, Hedgehogs, and Estrogens in the Prevention of Human Disease,” in which he outlined studies showing experimental benefits against prostate cancer  with high concentrations of genistein from soy, EGCG from green tea, curcumin and resveratrol, and low concentrations with the new botanicals under study, like sutherlandia (Lessertia frutescens), and how these plant compounds are able to hold back unwanted signaling in mouse and human prostate cancer cell lines, which researchers link to estrogen and which may point to benefits for cancers in women.

Dr. Helferich’s presentation, entitled Isoflavones and Breast Cancer Growth and Progression: Insights From Pre-Clinical Models,” pointed to a potentially better safety profile for soy genistein-containing diets (for example, from fermented foods) than from isolated extracts of genistein.

Dr. Lipski’s entertaining talk was entitled “Women and Digestive Issues: Focus on IBS, Constipation and Leaky Gut.” She gave a detailed discussion of the intestine’s impact on virtually every single health area, and covered such as topics as small intestinal bacterial overgrowth (SIBO), dysbiosis and depression, psychiatric symptoms and irritable bowel syndrome (IBS), fibromyalgia, leaky gut and associated conditions, the benefits of bone broths and gut-healing foods, and supplements and dietary approaches to all of these conditions.

With the event having been organized by the NHRI and the American Nutrition Association, and hosted by the University of Illinois at Chicago College of Pharmacy, support for the conference was provided by the NOW® Health Group and Kabco Pharmaceuticals. The conference proceedings are available here.

About the NHRI

The NHRI is an independent, non-profit organization that supports science-based research on natural health and wellness.  It is committed to informing consumers, scientists, the media, policymakers and legislators about scientific evidence on the usefulness and cost-effectiveness of diet, supplements and a healthy lifestyle to improve health and wellness, and reduce disease around the world.