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, email@example.com.