FDA declines petition, sticks with soy protein’s heart health claim

02-Feb-2016 - Last updated on 02-Feb-2016 at 16:46 GMT

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The FDA will not revoke soy protein's health claims, as requested by a citizen petition. But the agency also admits that there will still be ongoing review on the ingredient.

The Department of Health and Human Services recently wrote a response to a 2008 citizen petition filed against the FDA, declining the petition’s request to revoke soy protein’s health claims in food labelling.

“Not soy in its natural form”

The petition was filed by Weston A. Price Foundation, whose website describes it as a “non-profit, tax-exempt nutrition education foundation.” The Foundation’s website also hosts many content promoting raw milk consumption. Ricardo Carvajal, a lawyer in the foods and dietary supplements industry at Hyman, Phelps, & Mcnamara, blogged about the issue last year.

“The complaint alleges that '[t]he totality of scientific research shows that the benefits of consuming soy protein are putative and unproven,' and that soy protein actually poses certain risks to health,” Caravajal wrote. The foundation also wrote that soy protein is “not soy in its natural form.”

According to Caravajal, the FDA was already reevaluating the challenged claim of soy proteins in 2007, in response to new scientific evidence—the Foundation filed its petition seeking revocation of the claim while the claim was already under scrutiny.

The FDA was compelled to write a response after the foundation sued the agency in 2014.

‘Moderate quality’ research

In its response letter, the FDA described the studies cited by the Foundation as “moderate quality,” and wrote that the “relevant evidence submitted in the petition and the petition supplement does not provide sufficient grounds for the Agency to revoke the soy protein and coronary heart disease health claim at this time.” (The petition supplement was submitted on November 9, 2015).

“The petition failed to address the significant number of intervention studies that do show a reduced risk of CHD,” Caravajal wrote in another blog post, adding that the foundation’s failure to include such studies is “a critical deficiency.”

According to Caravajal, FDA’s response does not mean the health claim is in the clear. In FDA’s response, the agency wrote that it is “actively reviewing the entire body of scientific evidence to allow the Agency to make a more well-informed decision regarding next steps for this health claim.”

The FDA also assured the Foundation that the agency intends to “consider the six relevant studies [the Foundation] submitted—as part of an ongoing review.”