Fat substitutes: a regulatory perspective

Fat substitutes, in theory, may provide special health benefits to certain population segments. The most probable benefits are a reduction in total fat intake and a subsequent reduction in intake of calories from fat. Whether individuals who consume high intakes of fat substitutes that are partially or totally nondigestible also benefit from lower calorie intake on a long-term basis is unknown. It is likely that many individuals will compensate by increasing total food intake to maintain calorie intake. Consumption of fat substitutes presents nutrition problems. Those fat substitutes that are partially or totally nondigested may reduce the bioavailability of other nutrients. Similarly, fat substitutes may have adverse effects on normal gastrointestinal tract function or intestinal tract flora. Unlike other functional food additives, fat substitutes can make up a significant portion of the total diet. For this reason, traditional safety factors cannot be applied. Consequently, more reliance on data from clinical studies involving human subjects and requirements for postmarket surveillance will be necessary as part of the approval process.