Substance/disease relationships that do not meet the standard of SSA may become qualified health claims through petitions to FDA that provide credible scientific support. Such claims require a disclaimer or other qualifying language on a product’s labeling that convey the level of scientific support for the relationship. Examples of qualified health claims include:
“Vitamin C may reduce the risk of colon cancer. The scientific evidence supporting this claim is persuasive, but not conclusive.”
“Although the evidence is not conclusive, tomato products, which contain lycopene, may reduce the risk of prostate cancer.”
“Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.”
Should FDA finalize this rule and a petition for the soy protein and CHD relationship provide sufficient scientific support, the Agency may consider it a qualified health claim. FDA issues Letters of Enforcement Discretion that outline specific language, similar to the examples above, for making qualified health claims on a product’s label. Food manufacturers who previously displayed the authorized claim may need to adjust their labeling to reflect potential changes.
While this proposed rule does not enact certain or immediate changes, food manufacturers should be conscious of health claims on their labeling, especially when updating to comply with FDA’s new label rules. Labels presenting claims that are not authorized or qualified are considered misbranded. Marketing a misbranded food product in the United States is a prohibited act that may be met with Warning Letters, detentions, or other enforcement actions.
