Abstract
The US Food and Drug Administration (FDA) has premarket review authority over food additives, but a food manufacturer may, according to the legislation, intentionally add a substance to human food or animal food without their premarket review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use. Generally recognized as safe (GRAS) implies that the current scientific community agrees on the adequacy of how data is generated. This system has come under public pressure because of doubts as to its efficiency and the FDA's recent GRAS rule is part of the response. The FDA guidance for testing food additives, known as the "Redbook", is about two decades old. Work toward a new "Redbook" is on the way, but the US Grocery Manufacturer Association (GMA) also has initiated the development of an independent standard on how to perform GRAS determinations. This review of the current guidance shows a very rigorous system for higher concern levels, but also many waiving options. Opportunities and challenges for safety evaluations of food additives are discussed. Where scientific progress has allowed improving existing and adapting new methods, these should be adopted to improve product safety and animal welfare. The continuous adaptation of such improved methods is therefore needed. Especially, there are opportunities to embrace developments within the toxicity testing for the 21st century movement and evidence-based toxicology approaches. Also, the growing understanding of the limitations of traditional tests needs to be considered.
Highlights
Food for thought... and vice versa this time
The GRAS process has come under recent criticism by the US Government Accountability Office (GAO)3: “The Food and Drug Administration (FDA), which is responsible for ensuring the safety of most of the U.S food supply, is not required to review substances, such as spices and preservatives, added to food that are generally recognized as safe (GRAS) for their intended use
Under the 1958 Food Additives Amendment to the Federal Food, Drug and Cosmetic Act (FFDCA) (Congress, 1958), any substance intentionally added to food is a food additive and subject to pre-market approval by FDA unless the use of the substance is generally recognized as safe (GRAS), or otherwise exempt from the definition of food additive, e.g., color additive
Summary
Food for thought... and vice versa this time. An earlier article in this series (Hartung and Koëter, 2008), on food safety, was written mainly from a European perspective – unavoidably as both authors were part of the European Commission: Herman Koëter, as acting head of the European Food Safety Authority (EFSA), and I, shortlisted to become possibly Director for Food Safety in what was the EC Directorate General Health and Consumers (DG SANCO, DG SANTE). A decade later, eight of these years spent in the US, this article addresses a key pillar of the US system, the generally recognized as safe (GRAS) provisions This is how the safety of most food additives is assessed in the US and one of the more contended aspects of US food law. An enormous number of chemicals are added either directly or indirectly (as contaminants such as pesticides or contact materials) to US food Many of these have no (public) data as to their safety; Neltner et al (2013a) report that “Less than 38% of FDA-regulated additives have a published feeding study. “The Food and Drug Administration (FDA), which is responsible for ensuring the safety of most of the U.S food supply, is not required to review substances, such as spices and preservatives, added to food that are generally recognized as safe (GRAS) for their intended use.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
