Results from clinical studies reveal that pantethine is well tolerated although there are occasional reports of heartburn, mild pruritis, gastrointestinal discomfort and diarrhea, most frequently when administered in higher doses i.e. 350-1200 mg/day and higher. The Panel concludes that the bioavailability of pantothenic acid from pantethine upon oral intake might be comparable to or lower than that of pantothenic acid. Given the facts that: i) the bioavailability studies in rats indicate that part of the pantethine might be absorbed unmodified and that in first instance only part may be converted to pantothenic acid, ii) the metabolic fate of an oral dose of pantethine in humans has not been clearly described, iii) the margin of safety between the NOAELs from the animal studies and the exposure resulting from use levels of 500 to 900 mg/day of pantethine is less than 10 and, iv) results from clinical studies with pantethine indicate that at dose levels between 350-1200 mg/day, occasional cases of heartburn, mild pruritis, gastrointestinal discomfort and diarrhea occur, the Panel concludes that the safety in use of pantethine as a source for pantothenic acid in food supplements intended for the general population at levels of use of 500 to 900 mg pantethine/day is not demonstrated. The Panel also concludes that when use levels are 10 mg/day (0.167 mg/kg bw for a 60 kg person), as reported by the petitioner to be used typically in multivitamin/mineral supplements or vitamin B complex supplements in European food supplement products, the margin of safety would be 216 to 300. In view of this margin of safety, the Panel concluded that the use of pantethine as a source of pantothenic acid under these conditions would not be of safety concern.
Pantethine as source for pantothenic acid added as a nutritional substance in food supplements
GRILLI, SANDRO;
2008
Abstract
Results from clinical studies reveal that pantethine is well tolerated although there are occasional reports of heartburn, mild pruritis, gastrointestinal discomfort and diarrhea, most frequently when administered in higher doses i.e. 350-1200 mg/day and higher. The Panel concludes that the bioavailability of pantothenic acid from pantethine upon oral intake might be comparable to or lower than that of pantothenic acid. Given the facts that: i) the bioavailability studies in rats indicate that part of the pantethine might be absorbed unmodified and that in first instance only part may be converted to pantothenic acid, ii) the metabolic fate of an oral dose of pantethine in humans has not been clearly described, iii) the margin of safety between the NOAELs from the animal studies and the exposure resulting from use levels of 500 to 900 mg/day of pantethine is less than 10 and, iv) results from clinical studies with pantethine indicate that at dose levels between 350-1200 mg/day, occasional cases of heartburn, mild pruritis, gastrointestinal discomfort and diarrhea occur, the Panel concludes that the safety in use of pantethine as a source for pantothenic acid in food supplements intended for the general population at levels of use of 500 to 900 mg pantethine/day is not demonstrated. The Panel also concludes that when use levels are 10 mg/day (0.167 mg/kg bw for a 60 kg person), as reported by the petitioner to be used typically in multivitamin/mineral supplements or vitamin B complex supplements in European food supplement products, the margin of safety would be 216 to 300. In view of this margin of safety, the Panel concluded that the use of pantethine as a source of pantothenic acid under these conditions would not be of safety concern.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
