The GRAS Substances (SCOGS) Database allows access to opinions and conclusions from 115 SCOGS reports published between 1972-1980 on the safety of over 370 Generally Recognized As Safe (GRAS) food substances. The GRAS ingredient reviews were conducted by the Select Committee in response to a 1969 White House directive by President Richard M. Nixon.
- SCOGS-Report Number: 51*
- Type Of Conclusion: 1
- ID Code: 87-89-8
- Year: 1975
- 21 CFR Section: 184.1370
Inositol is a naturally-occurring substance that is widely distributed in plant and animal tissues and synthesized in animals and man. Orally administered inositol is absorbed slowly and is metabolized. The available information form toxicological studies in animals suggests no adverse effects associated with consumption of inositol at levels considerably in excess of those now consumed by humans.
Despite the demonstration of signs of inositol deficiency in several animal species, no requirement for dietary inositol in man has been established. The high inositol concentration of human milk, and the relatively low concentration in cow's milk, together with the inadequate understanding of inositol metabolism and utilization during neonatal development in animals and man, suggest the possibility that basic infant formulas, particularly milk-free preparations, may contain less inositol than is necessary for optimal growth and development. The rationale for adding inositol to certain infant formulas is based on an assumption that the greater intake insures against a possible deficiency of inositol during early growth and development, when the need for dietary sources of inositol might be maximal. However, if future investigations should clearly demonstrate a need for additional inositol in infant formulas, and if that need should be greater than the amount now added, it is unlikely that the recommended level of intake would exceed that supplied by human milk.
The Select Committee has considered the foregoing and concludes that:
There is no evidence in the available information on inositol that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when it is used at levels that are now current or that might reasonably be expected in the future.
*Complete reports containing details of the safety studies that formed the basis of the opinions and conclusions and are available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (703) 605-6000.