The Food and Drug Administration yesterday advised about its proposal to revoke—for the very first time—an “authorized” health claim, that is, a health claim authorized by the agency, for soy protein and a reduced risk of heart disease. If this rule is finalized, the agency would still allow for “qualified” health claims “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 requires a lower level of scientific standard of evidence.
You can read the full text of the proposed rule here (PDF).
The following is a statement issued by Susan Mayne, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition, regarding the agency’s reasonings for this action.
Note that a 75-day comment period will commence before final rulemaking by the agency. We will inform the membership about how and where to comment, along with any additional information, as we receive it.
Click here for coverage of this issue in foodnavigator-usa.com’s newsletter, with comments from industry groups on the proposal.
With warm regards,
by Susan Mayne, Ph.D., director, FDA’s Center for Food Safety and Applied NutritionWe’ve long recognized that some foods and nutrients can help reduce the risk of certain diseases or conditions. Since 1990, the FDA has been responsible for evaluating health claims on packaged foods to ensure that they are rooted in strong science. 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.
FDA-authorized health claims reflect well-established relationships based on the most robust level of scientific evidence. Today, we are proposing a rule to revoke a health claim for soy protein and heart disease. For the first time, we have 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.
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 – the totality of currently available scientific evidence calls into question the certainty of this relationship. For example, 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. Our review of that evidence has led us 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, 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. 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.
For consumers who have questions about eating soy products, we recommend 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. We note 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.