Generally regarded as safe GRAS

Chamomile appears very low in toxicity. It has been listed as Generally Regarded as Safe (GRAS) by the Food and Drug Administration (Tyler 1994). Adverse reactions may include allergic reactions to the pollen in the flowers (Kowalchick and Hylton 1987 Subiza et al. 1990). 

A recent publication by James A. Duke lists the phytochemical constituents of generally-regarded-as-safe (GRAS) herbs (Duke, 2000a). It is also available as a searchable database on disk (WordPerfect 5.1 macros). There is also a volume dealing with 365 herbs having medicinal or folklore medicinal properties (Duke, 2000b). 

They have a long history of industrial applications in brewing and baking, and many of them are generally regarded as safe (GRAS). 

Food items have contained a variety of artificial sweeteners (e.g., saccharin, sorbitol, cyclamate). These sweeteners are permitted for use by the United States Food and Drug Administration (USFDA) based on their grouping under generally regarded as safe (GRAS). However, reports and regulatory decisions on the use of artificial sweeteners are inconclusive and often contradictory, and therefore require reevaluation. 

Sections 182, 184, 185—Generally Regarded as Safe (GRAS) Lists... 

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. 

The United States. Ascorbic acid is generally regarded as safe, GRAS, for use in food as a nutrient or food processing aid provided that a standard has not been established by the Food and Drug Administration for the food wherein the use of ascorbic acid is excluded or permitted within the limitations specified by the standard. 

Criteria for selecting polymorphs and solvates are shown in Table 12.2. For drug substances, hydrates are preferred over solvates of organic solvents, due to toxicity considerations. The structural solvent in marketed crystalline drugs is almost invariably water [12] or a nontoxic substance such as EtOH that is generally regarded as safe (GRAS). 

Some spray-dried particles have been prepared using other generally regarded as safe (GRAS) substances such as lecithin, human serum albumin, polylysine, and polyarginine, but these have also not yet been included in approved products for delivery to the lungs. 

The selection of the components to be used in the microemulsion is a very critical step. The pharmaceutical acceptability of the components and their toxicity issues must be considered. A large number of oils and surfactants are available, but their use in the microemulsion formulation is restricted due to their toxicity, incompatibility, and stability. Components that are used for the formulation of microemulsion should be biocompatible, nontoxic, and clinically acceptable. Emulsifiers should be used in an appropriate concentration range that will result in mild and nonaggressive microemulsion. The selection of generally regarded as safe (GRAS) excipients should always be emphasised. " ... 

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