Generally Regarded As Safe status

GRAS (generally regarded as safe) status so far, only Bifidobacterium sp. and Lactobacillus sp. have received GRAS status from the US FDA to be used for human consumption. 

Synthetic sweeteners have had checkered careers as excipients. Cyclamate was banned in the United States following reports of carcinogenicity and withdrawal of generally regarded as safe (GRAS) status in 1969. It remains banned despite additional studies to clarify safety and attempts at reinstatement. It remains acceptable in Europe. 

Both chitosan and COS are covered by the same regulatory status and are approved for use as a dietary supplement in most of the countries. However, only in certain countries it is allowed to be used as a food additive. In the United States presently, neither chitosan nor COS have generally regarded as safe (GRAS) status. On the other hand, in Korea and Japan it is accepted as a certified functional food ingredient for cholesterol control [190]. Chitosan has been sold as a weight-loss dietary supplement for over 20 years in Europe, Japan, and Korea, but has entered the U S. market only 10 years ago [190]. Recently, a trend of substitution of chitosan market with COS has been observed, mainly in the chitosan mature markets, such as Japan and Korea. The main producers of chitosan and COS are Japan and Korea followed by China and the United States. Smaller operations can be foimd in India,... 

Currently plant sterols are derived on a commercial scale from vegetable oils and from wood. Sterol blends from both these sources have been extensively studied regarding their safety parameters and their cholesterol-lowering efficacy, both in animals and in humans. Free and esterified soy sterols, free tall oil sterols, and stanol esters from both sources have obtained GRAS ( generally recognized as safe ) status in the USA. 

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