i- Since 1990, the U.S. Food and Drug Administration (FDA) has evaluated health claims on packaged foods to ensure that they are adequately substantiated. A health claim characterizes the relationship between a substance and its ability to reduce the risk of a disease or health-related condition (see 21 CFR 101.14). A health claim must contain the elements of a substance and a disease or health-related condition. In addition, health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease. Health claims are required to be reviewed and evaluated by FDA prior to use via a petition process. There are two types of health claims: (1) health claims that meet the standard of significant scientific agreement (SSA) and (2) qualified health claims. To date, FDA has authorized 12 SSA 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.
- Today, FDA released a rule proposing to revoke its regulation authorizing the use of a health claim on the relationship between soy protein and coronary heart disease (21 CFR 101.82) on the label or in the labeling of foods. In developing the proposed rule, the Agency reviewed more than 700 publications identified through literature searches, comments and other information, including information solicited by the FDA in 2007.
- In a statement announcing the release of the proposed rule, Dr. Susan Mayne of FDA’s Center for Food Safety and Applied Nutrition noted that this action represents the first time FDA has considered it necessary to propose a rule to revoke a health claim. FDA indicates that it is basing this decision on its view that the totality of publicly available scientific evidence currently available calls into question the Agency’s previous determination that there is significant scientific agreement (SSA) among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease. Importantly, the Agency notes that some evidence continues to suggest a relationship between soy protein and a reduced risk of heart disease.
- The FDA plans to publish the proposed rule in the Federal Register and solicit public comments and scientific information concerning the proposal for 75 days following its imminent publication. During the rulemaking process, food manufacturers may continue to use the authorized health claim.
- If the FDA ultimately finalizes this rule, the Agency intends to allow the use of a qualified health claim provided that 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 permit industry to use qualifying language that explains the limited evidence linking consumption of soy protein with heart disease risk reduction.
FDA Releases Proposed Rule Seeking to Revoke Health Claim that Soy Protein Reduces Risk of Heart Disease
Monday, October 30, 2017
