Comment from Luminary Medicine Company

Dear FDA Officials, I am writing to formally request reconsideration of the current Nutrition Facts labeling guidance regarding D-psicose (allulose), specifically its mandatory inclusion in the “Total Carbohydrate” line while being excluded from “Sugars” and “Added Sugars.” Allulose is a rare sugar with a near-zero caloric value (0.4 kcal/g) and no measurable glycemic or insulin impact, as recognized by the FDA in its April 2019 guidance. Yet, its inclusion in the "Total Carbohydrate" declaration creates a misleading picture for individuals with diabetes, who often use carbohydrate values to calculate insulin dosing or monitor blood glucose response. Including allulose as a standard carbohydrate, without further context or exemption, can result in: Overestimation of insulin needs Risk of hypoglycemia Inaccurate net carb reporting for low-glycemic formulations Many manufacturers are currently providing non-binding disclaimers (e.g., “Includes Xg allulose not counted toward net carbs”), but this practice is inconsistent and not always understood by consumers. In light of the metabolic behavior of allulose—and its relevance in diabetic and ketogenic nutrition—I respectfully request the FDA: 1. Reconsider the mandatory inclusion of allulose in Total Carbohydrates, or 2. Permit optional disclosure or footnoting, such as “Allulose: 8g – does not affect blood sugar,” and 3. Consider whether allulose qualifies for a fiber-like classification based on its physiological effects (e.g., lack of digestion, prebiotic properties under study, and absence of glycemic response) Additionally, clear public-facing guidance for diabetic consumers would be a welcome step toward transparency and safety in food labeling. Thank you for your time and consideration of this matter. I would welcome the opportunity to provide further commentary or participate in any relevant stakeholder discussions on this topic.