Evaluating health claims associated with natural product content of foods, such as effects of soy protein on blood cholesterol

A health claim on the label or advertising of a food states, suggests or implies that a relationship exists between consumption of the food and health. All food health claims are voluntary and must not be false, misleading or deceptive. Claims related to a list, set out in Canadian law, of serious diseases, disorders and abnormal states (e.g., diabetes) are prohibited unless an exemption has been granted based on a pre-market evaluation. While other health claims are subject to post-market federal compliance verification, stakeholders can make a voluntary submission for pre-market evaluation. Proposed health claims are evaluated in a systematic, comprehensive and transparent manner to ensure they are valid. For example, the Food Directorate recently completed evaluation of a voluntary submission for a food health claim regarding consumption of soy protein and cholesterol lowering. Systematic review and meta-analysis showed significant (P < 0.00001) reductions in total cholesterol (-0.15 mmol/L, 95% C.I. -0.21 to -0.08) and LDL-cholesterol (-0.15 mmol/L, 95% C.I. -0.19 to -0.11) levels (approximately 2.6% and 4%, respectively) with consumption of soy protein vs. non-soy controls. Epidemiological and intervention data suggest that for every 1% reduction in LDL-C there is a corresponding 1 – 2% reduction in cardiovascular events, making reduction of elevated LDL-cholesterol an important public health goal.