Generally recognized safe

Generally Recognized Safe and Effective Over4fie-Counter Drugs... 

Glycerol, since 1959, is generally recognized as safe (GRAS) as a miscellaneous or general-purpose food additive (qv) under the CFR (20), and it is permitted in certain food packaging (qv) materials. 

The conditions whereby dandmff, seborrheic dermatitis, and psoriasis dmg products are generally recognized as safe and effective and are not misbranded is available (70). Specific active iagredients that can be used as well as the statement of identity, iadications for use, and required warnings, are identified. Products that do not meet all of these requirements are considered new dmgs and must have an approved NDA for the nonmonograph conditions. 

Lactic acid is generally recognized as safe (GRAS) for multipurpose food use. Lactate salts such as calcium and sodium lactates and esters such as ethyl lactate used in pharmaceutical preparations are also considered safe and nontoxic (7). The U.S. Food and Dmg Administration fists lactic acid (all isomers) as GRAS and sets no limitations on its use in food other than current good manufacturing practice (46). 

Health and Safety. The U.S. FDA has affirmed R%- and S(—)-maHc acid as substances that are generally recognized as safe (GRAS) as flavor enhancers, flavoring agents and adjuvants, and as pH control agents at levels ranging from 6.9% for hard candy to 0.7% for miscellaneous food uses (42). R%- and A(—)-maHc acid may not be used in baby foods. MaHc acid is also cleared to correct natural acid deficiencies in juice or wine (43). 

Health and Safety. The FDA affirmed (R-R, R -tartaric acid as a generally-recognized-as-safe (GRAS) food substance (88). 

Fermented Products. Fermented meat products such as semidried and dried sausages are generally recognized as safe, if critical points during processing are controlled properly. Some of the sausage processors use a small amount of fermented product as the starter for a new batch of product. 

An ingredient used in food prior to January 1, 1958 can be considered GRAS under the conditions of its intended use based on common use in food. PDA prior approval generally is not necessary. A post-1958 food ingredient that is generally recognized by qualified experts as safe, under the conditions of its intended use based on scientific tests, is GRAS by definition and therefore is not a food additive and does not require PDA approval prior to use. 

Potassium sorbate, but not sorbic acid, is generally recognized as safe for use in animal feeds (154) and in paper and paperboard products for food packaging (155). 

Sodium dithionite is considered only moderately toxic. The solution is reported to have an LD q (rat, oral) of about 5 g/kg. As with sulfites, fairly large doses of sodium dithionite can probably be tolerated because oxidation to sulfate occurs. However, irritation of the stomach by the Hberated sulfurous acid is expected. As a food additive, sodium dithionite is generally recognized as safe (GRAS) (367). 

Salt apphed as equal parts of unionised sodium chloride and calcium chloride at 20 g total per L for 1 h, three times a week, has also been used to control fungal infections on eggs. The salt combination is first appHed one day after fertilisation to the first pick of eggs. These compounds are categorized as generally recognized as safe (GRAS). 

Benzaldehyde is a synthetic flavoring substance, sanctioned by the U.S. Food and Dmg Administration (FDA) to be generally recognized as safe (GRAS) for foods (21 CFR 182.60). Both "pure almond extract" and "imitation almond extract" are offered for sale. Each contains 2.0—2.5 wt % benzaldehyde in an aqueous solution containing approximately one-third ethyl alcohol. 

Flavor. Dentifrices are used to refresh the oral cavity. Flavor oils and other flavoring materials are key to that function (see Flavors and spices). Generally recognized as safe (GRAS) flavors or flavors from approved lists are used. The most popular flavors are peppermint [8006-90-4], spearmint [8008-79-5], cinnamon [8006-79-9], and mixtures of these. Menthol is a principal constituent of the mint flavors and a source of refreshment and coolness. 

So when someone warns that there is antifreeze in your toothpaste, ask which antifreeze. Some are illegal adulterants added by criminal cost-cutters, and their products are quickly recalled. Others (like glycerin, propylene glycol, or salt) are generally recognized as safe and are reasonable household ingredients. 

Chitosan for oral administration to humans is generally recognized as safe. In vitro, chitosan has been reported to bind bile acids The role of the accompanying anion is important for instance chitosan orotate salt has enhanced capacity for bile acids [11,264-267]. 

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