Generally recognized as effective

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. 

The two most important diphenylmethanes are phenolphthalein and bisacodyl. Senna and cascara are the sources of anthraquinone laxatives. However, although still available in some countries phenolphthalein is now removed from most markets because of concerns over carcinogenicity. As recent as 2006 the United States Food and Drug Administration (FDA) has categorized castor oil as generally recognized as safe and effective (GRASE) for over-the-counter use as a laxative. On the other hand, in 2002 cascara was banned by the FDA. 

A new drug application, described in part 314. Data and information regarding an over-the-counter drug for human use, submitted as part of the procedures for classifying such drugs as generally recognized as safe and effective and not misbranded. Described in part 330. 

In the field of muscle foods, the use of marination before irradiation reduced the dose necessary to eliminate Salmonella in poultry [113]. Some antimicrobial additives, especially the natural ones (e.g., bacteriocins) [94] and GRAS (generally recognized as safe) preservatives [114] can be usefully combined with irradiation to reduce dose requirements. Some antioxidants have also been used to prevent the undesirable oxidative effects in irradiated foods. 

Department of Health, Human Services, Food, Drug Administration. 21 CFR 330. Additional criteria and procedures for classifying over-the-counter drugs as generally recognized as safe and effective and not misbranded. Final Rule Fed Reg 2002 67(15) 3060-3076. 

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