Heart Health Claims for Soy Protein Challenged

WASHINGTON (CN) - Soy protein may not have the heart health benefits the industry claims, according to a lawsuit filed against the Food and Drug and Administration.

The Weston A. Price Foundation sued the FDA, Commissioner Margaret Hamburg and Secretary of Health and Human Services Kathleen Sebelius in Federal Court, asking the judge to force the agency to answer a six-year-old citizen petition seeking to revoke an agency ruling that opened the door to the now nearly ubiquitous "heart healthy" claims bestowed on soy protein products.

"Soy protein is not soy in its natural form," the group says in its complaint. "Soy protein concentrate and soy protein isolate are highly processed products that are precisely manufactured under industrial conditions in chemical factories, not kitchens. The basic procedure begins with defatted soybean meal, which is mixed with a caustic alkaline solution to remove the fiber, then washed in an acid solution to coagulate the protein. The protein curds are then dipped into yet another alkaline solution and spray-dried at high temperatures."

The complaint adds: "Soy protein isolates are a component of numerous food products today, including energy bars, shake powders, pasta sauces, burgers and hot dogs. Soy protein isolate is also the major ingredient in most of today's soy infant formulas."

Despite the unappetizing picture painted by the foundation, the group claims the FDA passed a final rule in 1999 that allows companies peddling food products containing soy protein to advertise the products as being heart healthy alternatives to meat and dairy.

But the group points to numerous studies conducted after the 1999 rule that contradict the agency's findings.

"Studies cited in the Citizen Petition show that soy protein can actually contribute to or cause heart disease, including endothelial damage (especially in women), heart arrhythmias and cardiomyopathy, an increasingly prevalent condition that afflicts 1 in 500 Americans," the complaint states. "Soy protein isolate contains a number of toxins and carcinogens, which are introduced into the product through its manufacturing process using high temperatures, high pressures, and harmful chemicals. Additional recent studies have failed to demonstrate that soy has beneficial effects on heart disease factors."

The bad advice puts at risk vegetarians and vegans who eat the dangerous soy products as a replacement to meat and dairy products, , the foundation claims.

Infants fed soy formula are also at risk, the group says.

"Toxicologists, endocrinologists and other expert scientists have questioned the safety of soy protein because of the known presence of antinutrients (protease inhibitors, phytates, lectins, saponins and oxalates) as well as the plant hormones known as phytoestrogens," the group says in the complaint. "A large body of research exists, documenting these hazards and refuting industry claims that there are no known safety hazards associated with soy protein."

The group also cites studies claiming soy protein and soy isolates are rich in harmful nitrates.

The foundation says the FDA violated the Administrative Procedures Act when it ignored the group's citizen petition, and wants the judge to force the agency to respond.

It is represented by James Turner of Swankin Turner in Washington, D.C.

Subscribe to Closing Arguments

Sign up for new weekly newsletter Closing Arguments to get the latest about ongoing trials, major litigation and hot cases and rulings in courthouses around the U.S. and the world.

Email *

Submit