FDA statement explains decision to revoke soy protein heart health claim

07 Nov 2017 --- The FDA’s Director of the Center for Food Safety and Applied Nutrition, Susan Mayne, Ph.D., has issued a statement clarifying the organization’s decision to revoke the health claim that soy protein reduces the risk of heart disease.
The decision is a setback for a space that has recently had some good news with health claims. For example, it comes shortly after Bunge’s qualified soybean oil heart health claim was approved by the FDA. Soy protein was also noted to be a plant protein with 25 percent growth in sports nutrition launches tracked by Innova Market Insights (Global, 2016 vs. 2015).

Ensuring claims are rooted in strong science
The FDA has long recognized that some foods and nutrients can help reduce the risk of certain diseases or conditions, Mayne notes. “Since 1990, the FDA has been responsible for evaluating health claims on packaged foods to ensure that they are rooted in strong science,” she explains. “To date, we have authorized 12 such health claims, such as the effect of calcium and vitamin D in helping to lower the risk of osteoporosis or certain fruits and vegetables to lower the risk of cancer.”

Noting that FDA-authorized health claims reflect well-established relationships based on the most robust level of scientific evidence, Mayne points out that for the first time, the FDA has considered it necessary to propose a rule to revoke a health claim because numerous studies published since the claim was authorized in 1999 have presented inconsistent findings on the relationship between soy protein and heart disease.

“This proposed action, which has undergone a thorough FDA review, underscores our commitment to providing consumers with information they can trust to make informed dietary choices,” Mayne explains.

While some evidence continues to suggest a relationship between soy protein and a reduced risk of heart disease – including evidence reviewed by the FDA when the claim was authorized – Mayne suggests that the totality of currently available scientific evidence calls into question the certainty of this relationship.

Some studies, published after the FDA authorized the health claim, show inconsistent findings concerning the ability of soy protein to lower heart-damaging low-density lipoprotein (LDL) cholesterol. The FDA’s review of that evidence has led it to conclude that the relationship between soy protein and heart disease does not meet the “rigorous standard” for an FDA-authorized health claim.

Should the FDA finalize this rule, the agency intends to allow the use of a qualified health claim as long as there is sufficient evidence to support a link between eating soy protein and a reduced risk of heart disease. A qualified health claim like that of Bunge, which requires a lower scientific standard of evidence than an authorized health claim, would allow industry to use qualifying language that explains the limited evidence linking consumption of soy protein with heart disease risk reduction.

“We look forward to working with stakeholders and others interested in this topic throughout the rulemaking process and invite them to submit comments on the proposed rule,” Mayne adds. “The comment period will be open for 75 days, at which time we will consider the comments received along with the existing information we have to determine whether to proceed with final rulemaking. In the meantime, manufacturers will be allowed to keep the current authorized claim on their products until the agency makes a final decision.”

Further advice on soy products
For consumers who have questions about eating soy products, the FDA recommends they continue to follow advice from the 2015-2020 Dietary Guidelines, which state that a healthy eating pattern can include soy beverages and a variety of protein foods, including soy products.

The FDA also notes that the authorized health claim at issue addresses only soy protein and reduced risk of coronary heart disease. Other purported health benefits of soy or soy-derived food ingredients (such as soybean oil) are not addressed as part of this proposed rule.

By Paul Creasy