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.
Choline bitartrate, Choline chloride
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21 CFR Section
Despite the significant endogenous synthesis of choline, it is an important dietary constituent for normal growth and well-being in all of the species that have been studied. Its metabolic role in fat transport is established. In addition, it is a contributor of methyl groups in essential transmethylation reactions in the animal body. However, the precise nutritional significance of dietary choline for man is not clear.
In evaluating the possible effects of choline salts as added food ingredients, particularly on the infant which is the largest consumer of these supplements, the Select Committee recognizes the approximate nature of current estimates of total daily intake and the scarcity of chronic toxicity data. The latter information might be supplied by studies on preweanling animals. However, the available evidence raises no suspicion that choline chloride and choline bitartrate have harmful effects at dosage levels that are several orders of magnitude greater than the most generous current estimates of human intake.
The Select Committee has weighed the foregoing and concludes that:
There is no evidence in the available information on choline chloride and choline bitartrate 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.
*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.