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Supplements are known globally by various names like Dietary Supplements (DS), Health Food (HF), Food Supplements (FS), Natural Health Products (NHP), and Complementary Medicines (CM). Each category must meet local market standards for compliance, leading to differing regulations based on product classification. This session will cover a case study on the challenges and gaps in the Nutritional Fact Panel (NFP) analysis of dietary supplements, with examples from Canada and Australia markets to illustrate issues in meeting international requirements. NFP (Nutritional Facts Panel) is an analysis that requires a combination of parameter assessment. For the dietary supplements, these details are required to report on the product label by regulation which again is classified by different terms from different regulatory bodies around the world. In Canada, this is referred to as NFT (Nutritional Fact Table) as classified by Health Canada and Canadian Food Inspection Agency (CFIA). In Australia, the authority known as Food Standards Australia New Zealand (FSANZ) refers to it as the Nutritional Information Panel (NIP). Part of this NFT disclosure, calorie estimation is a critical parameter required to indicate product/formula attributes. The standard methodology for calorie estimation, as outlined by the United States Department of Agriculture in the “Energy Value of Foods,” Agricultural Handbook, and FDA 21 CFR Part 101.9 for food versus 21 CFR 101.36 for supplements, involves analyzing carbohydrates, dietary fiber, fats, protein, cholesterol, ash, moisture, and iron in any product. This session will conduct a structured review to identify specific challenges associated with gaps in current analytical methods. It will also address how a product development approach may result in biased data interpretation to examine the regulatory requirements that impact accurate labeling.
