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Frameworks have been developed to standardize the assessment of carcinogenic potential in the pharmaceutical and agrochemical industries, building upon decades of research. Carcinogenicity is also evaluated during the safety evaluation of food substances, using a comprehensive approach unique to each substance. To better understand these approaches, a retrospective assessment was conducted on the publicly available database of substances notified to the United States Food and Drug Administration (US FDA) as being Generally Recognized As Safe (GRAS). The data contained within these GRAS notifications (GRNs) were reviewed for the methods used to evaluate carcinogenic potential (genotoxicity studies, 2-year bioassays, other pre-clinical animal studies) to identify patterns that could provide an understanding of how this assessment has been conducted for different categories of food substances. While different approaches to the safety evaluation were required to adapt to the unique food substances, the data in all notifications supported the conclusion of safety. The evaluation of food substances for carcinogenic potential must consider all available data, including identifying the need for when more data must be generated to support an evaluation. Due to the complexity of substances used in food, ranging from defined chemical entities to minimally processed agricultural commodities to live microorganisms, the approach to conducting the safety evaluation of food substances must be able to adapt to the most relevant scientifically supported approach. This paper illustrates the data commonly used to support the safety of different types of food substances and proposes an approach familiar to other product sectors. [ABSTRACT FROM AUTHOR]

Stevia rebaudiana (Bertoni) Bertoni, commonly known as stevia, is a plant native to South America that has been cultivated for hundreds of years. In 1995, FDA revised its import alert on stevia leaves and extracts to allow for their use as dietary ingredients in dietary supplements. In 2007, the Joint FAO/WHO Expert Committee on Food Additives established a safe level of intake and specifications for steviol glycosides that included a minimum purity of 95% of seven named steviol glycosides. In 2008, FDA responded without questions to a Generally Recognized as Safe (GRAS) notice for the use of highly purified steviol glycosides obtained from stevia leaves as a general purpose sweetener in food. Due to the existing import alert, FDA filed, evaluated, and has not objected to more than 50 GRAS notices for the use of various high-purity steviol glycosides as sweeteners in food. In this paper, we highlight FDA's practices for filing and evaluating GRAS notices for steviol glycosides. We also provide a summary of the data and information presented in GRAS notices for steviol glycosides in the GRAS Notification program. FDA has received a new wave of GRAS notices that include alternative biotechnological methods for production of steviol glycosides., (Published by Elsevier Ltd.)

In the United States, chemical additives cannot be used in food without an affirmative determination that their use is safe by FDA or additive manufacturer. Feeding toxicology studies designed to estimate the amount of a chemical additive that can be eaten safely provide the most relevant information. We analyze how many chemical additives allowed in human food have feeding toxicology studies in three toxicological information sources including the U.S. Food and Drug Administration's (FDA) database. Less than 38% of FDA-regulated additives have a published feeding study. For chemicals directly added to food, 21.6% have feeding studies necessary to estimate a safe level of exposure and 6.7% have reproductive or developmental toxicity data in FDA's database. A program is needed to fill these significant knowledge gaps by using in vitro and in silico methods complemented with targeted in vivo studies to ensure public health is protected., (Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.)