The Scientific Basis for the Health Claim
Health Canada's Food Directorate reviewed scientific literature and conducted a meta-analysis of studies on soy protein and cholesterol. The evidence indicated that consuming soy protein can help reduce total and low-density lipoprotein (LDL) cholesterol. A statistically significant reduction in both total and LDL cholesterol was observed, with no negative impact on HDL cholesterol or triglycerides.
This health claim is considered relevant for the Canadian population due to prevalent unhealthy cholesterol levels. The assessment determined that 25 grams of soy protein daily is the minimum effective intake for the cholesterol-lowering effect. This amount is used to qualify foods and inform consumers.
Potential Mechanisms of Action
The exact ways soy protein lowers cholesterol are still being researched, but possible mechanisms include inhibiting cholesterol absorption, increasing bile acid excretion, or boosting LDL receptor activity. While isoflavones in soybeans have been studied, Health Canada and some studies suggest the cholesterol-lowering effect is primarily due to the protein itself.
Conditions for Using the Health Claim
Food products must meet specific criteria in the Food and Drug Regulations to use the health claim. These ensure that foods making the claim are generally healthy and provide a sufficient amount of soy protein. {Link: More details on these requirements can be found on the Lexology website https://www.lexology.com/library/detail.aspx?g=a8cf9c15-8c3e-4bb3-97c7-14063d976baa}.
Examples of Qualifying Foods
Qualifying foods include various soy products such as soy beverages, tofu, miso, tempeh, natto, soy nuts, and different forms of soy protein like isolate, concentrate, and flour. Certain soy products, like soy sauce and soybean oil, are excluded because they lack significant amounts of soy protein.
Labeling and Advertising Requirements
Health Canada mandates specific wording for labels and advertisements. {Link: The specific wording and other requirements for labels and advertisements are detailed on the Lexology website https://www.lexology.com/library/detail.aspx?g=a8cf9c15-8c3e-4bb3-97c7-14063d976baa}.
Health Canada's Assessment in Global Context
Comparing Health Canada's position to other international bodies provides perspective. The U.S. FDA historically authorized a similar claim, but the European Food Safety Authority (EFSA) rejected its application. These different outcomes stem from varying interpretations of scientific evidence and regulatory standards. Health Canada's approval was based on a thorough review of the totality of evidence.
| Feature | Health Canada (Canada) | European Food Safety Authority (EFSA) | U.S. Food and Drug Administration (FDA) (Historical) |
|---|---|---|---|
| Decision on Soy Protein Health Claim | Approved (2015) | Rejected (2012) | Approved (1999) |
| Primary Basis for Decision | Meta-analysis and totality of evidence supporting reduction in total and LDL cholesterol | Dismissed meta-analyses as inconclusive and requested additional data | Review of evidence indicating reduction in total and LDL cholesterol |
| Required Daily Intake | 25 grams of soy protein | Claim rejected, no intake established | 25 grams of soy protein |
| Labeling Requirements | Mandatory primary statement referencing 25g daily amount; specific wording for primary and secondary statements | No health claim permitted | Specific wording required, similar to Canada |
Conclusion: Navigating the Health Claim
Health Canada's comprehensive assessment, including a meta-analysis, provides a strong basis for the health claim linking soy protein to lower total and LDL cholesterol levels. This allows food manufacturers to use a regulated health claim on qualifying products, helping consumers make informed choices for heart health. The established criteria, such as the 25g daily intake and food composition standards, ensure responsible communication of this benefit. For more detailed information, the official Health Canada Summary of Assessment document is available.
