Select Committee on GRAS Substances (SCOGS) Opinion: D- or DL- Sodium pantothenate
D- or DL- sodium pantothenate
- SCOGS-Report Number: 93*
- Type Of Conclusion: 1
- ID Code: 867-81-2
- Year: 1978
- 21 CFR Section: There is no CFR citation.
Pantothenates occur in all tissues of the body and are essential for normal metabolic function. Daily consumption of calcium pantothenate added to foods by processors in the United States appears to be less than 0.08mg per capita (1.3mg per kg), a value that probably also represents total per capita daily consumption of pantothenates added to foods since sodium pantothenate and pantothenyl alcohol do not appear to be used by food processors.
It is estimated that the usual adult diet provides approximately 5 to 19mg (83 to 316mg per kg) of naturally occuring pantothenates daily. Animals of several species given 100 mg per kg or more of calcium pantothenate daily for several months showed no evidence of toxicity. Adult patients with disseminated or discoid lupus erythematosus receiving doses of 1g or more daily (16.6mg per kg) for several months manifested no evidence of toxicity. Although the evidence is scanty, there appears to be no reason to suspect teratogenicity, fetotoxicity or carcinogenicity from intakes considerably greater than those likely to be obtained from foods.
There is little information concerning the metabolism of L-pantothenic acid or its salts, although animals and human studies of administration of racemic mixtures of calcium or sodium pantothenate demonstrate no untoward effects at doses considerably higher than could be reasonably expected from pantothenates added to food.
There are no specifications listed for food grade sodium pantothenate. The Select Committee believes such specifications should be developed even though there appears to be no current use of sodium pantothenate.
The Select Committee has weighed the foregoing and concludes that: There is no evidence in the available information on D-pantothenyl alcohol, D- or DL- calcium pantothenate or D- or DL- sodium pantothenate that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current or that might reasonably be expected in the future.