. "Appendix A: Existing Frameworks or Systems for Evaluating the Safety of Other Substances." Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: The National Academies Press, 2005.
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Dietary Supplements: A Framework for Evaluating Safety
also clarify the types of evidence needed to establish GRAS status (Degnan, 2000).
GRAS DETERMINATION FOR FLAVOR INGREDIENTS: FLAVOR AND EXTRACT MANUFACTURERS ASSOCIATION EXPERT PANEL
Because flavor ingredients are a type of food additive, the flavor industry has to adhere to the requirements laid out in the 1958 FAA. To determine GRAS status for flavoring substances, the Flavor and Extract Manufacturers Association (FEMA), the trade organization of the flavor ingredients industry, created its own independent expert panel. The FEMA Expert Panel, which has been reviewing flavoring substances since soon after the passage of the FAA in 1958, includes qualified experts in toxicology, pharmacology, biostatistics, pharmacokinetics, biochemistry, pathology, nutrition, organic chemistry, medicinal chemistry, and metabolism (Woods and Doull, 1991). The panel evaluates the available data on safety and use of flavoring ingredients and assesses whether the ingredients meet the criteria for GRAS status.
The FEMA Expert Panel has developed a safety assessment evaluation process for determining GRAS status. Once an application for GRAS status is submitted to the panel with a complete literature search, the first step is preliminary assessment of the data for adequacy by FEMA staff. These data are then evaluated by the panel using the following criteria: (1) exposure to the substance in specific foods, (2) natural occurrence in foods, (3) chemical identity and chemical structure, (4) metabolic and pharmacokinetic characteristics, and (5) animal toxicity (Woods and Doull, 1991). The panel examines toxicity and metabolic data on structurally similar compounds and considers the history of use of the substance (Hallagan and Hall, 1995).
Based on the weight of the evidence and expert judgment, the panel reaches one of three conclusions: (1) GRAS, (2) not GRAS, or (3) insufficient data to determine GRAS status. If data are insufficient, the panel will reexamine the substance after more data are available. The designation of GRAS status on a flavor ingredient must be based on a unanimous decision by the panel.
COSMETICS INGREDIENT REVIEW
As is the case for dietary supplements, there is no premarket regulatory system for cosmetic ingredients other than color additives that are regulated directly by FDA. The Cosmetics Ingredient Review (CIR) Program was established in 1976 by the Cosmetic, Toiletry, and Fragrance Association