Generally recognized as safe (GRAS): history and description

Burdock, George A.; Carabin, Ioana G.

doi:10.1016/j.toxlet.2003.07.004

Cited by 173 publications

(95 citation statements)

References 2 publications

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“…'Redbook' (FDA, 1982), and the development of the Priority-based Assessment of Food Additives (PAFA) system (Smith and Rulis, 1981) that included a database with toxicological information on direct additives (those added directly to food)." Burdock and Carabin (2004) explained: "Generally recognized as safe (GRAS) is the self-determination of safety and regulatory compliance in an otherwise stringently regulated venue. GRAS is therefore unique in technologically advanced societies and is characteristic of American reliance on self-governance".…”

Section: Safety Is Defined As 'Reasonable Certainty In the Minds Of Cmentioning

confidence: 99%

“…In the scientific literature, however, there are many positive voices about the GRAS system (admitting that advocacy and watchdog groups rarely write scientific articles): Burdock and Carabin (2004): "The most resounding testimony to the viability of GRAS is the fact that few GRAS determinations by experts have been overturned and the number of GRAS substances found unsafe is vanishingly small when 10 https://www.snopes.com/quotes/berra/practicetheory.asp 11 http://www.gmaonline.org/file-manager/GRAS%20Code%20of%20Practice_1_091015.pdf 12 http://www.gmaonline.org/file-manager/GMA%20GRAS%20Modernization%20Initiative_1.pdf the standard. In the author's personal view, it is imperative that the standard must be committed to both sound and the most humane science.…”

Section: Summarize: "The So-called 'Gras Exemption' To the Statutory mentioning

confidence: 99%

“…These requirements change with concern level, which is based on chemical structure and exposure (notably, the tiered system applied for direct additives is separate from the tiered system used for indirect additives): − How to document, share and communicate such results − How to apply quality assurances such as Good Laboratory Practice and evidence-based principles − How and when to review an evaluation in the future − How to make older GRAS assessments and the revised GRAS ruling compliant with the standard − How to bridge this to international requirements, for example the process of the European Food Safety Authority (EFSA) Systematic evaluation of safety is key to the GRAS process. Burdock and Carabin (2004) remark: "Importantly, a substance must be found safe; it is insufficient to show only that there is no conclusive evidence that the use of a substance is unsafe" citing (Hutt and Merrill, 1991). This means that the substance of interest must be experimentally challenged to elicit possible adverse effects using scientific procedures known to do so.…”

Section: Safety Evaluations Under Gras Compliant With the Standard Tomentioning

confidence: 99%

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Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the US

Hartung

2018

ALTEX

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SummaryThe 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 21 st century movement and evidence-based toxicology approaches. Also, the growing understanding of the limitations of traditional tests needs to be considered.

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Section: Safety Is Defined As 'Reasonable Certainty In the Minds Of Cmentioning

confidence: 99%

Section: Summarize: "The So-called 'Gras Exemption' To the Statutory mentioning

confidence: 99%

Section: Safety Evaluations Under Gras Compliant With the Standard Tomentioning

confidence: 99%

See 1 more Smart Citation

Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the US

Hartung

2018

ALTEX

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“…376 GRAS is determined by experts qualified by scientific training and experience in evaluating safety. 377 The determination may be made by the manufacturer of the ingredient in question or by an independent laboratory. 378 Where a given GRAS Notice includes the notation, "FDA has no questions," this means that FDA does not have any problem with the premise and safety of the proposed use, and that the manufacturer may move forward with producing its product.…”

Section: Grasmentioning

confidence: 99%

Food and Dietary Supplement Package Labeling—Guidance from FDA's Warning Letters and Title 21 of the Code of Federal Regulations

Brody¹

2015

Comp Rev Food Sci Food Safe

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Package labels for foods and dietary supplements must conform with Title 21 of the Code of Federal Regulations. This review provides guidance for the content and format of labels, including for the Nutrient Facts panel and Supplement Facts panel, and for drafting structure/function claims, health claims, and nutrient content claims. Also provided is guidance on how to refrain from drafting disease claims. Inappropriate disease claims on a food or dietary supplement compels FDA to review the product as a drug. Disease claims is the most common source of complaint in FDA's warning letters. This review makes use of all of FDA's warning letters that were published over a 14-y span (2002to 2015). This is the first comprehensive review on package labels to make use of FDA's warning letters as a source document.

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“…Natural feed additives of plant origin, also referred to as phytogenic substances are healthier, less regarded as chemical hazards and generally regarded as safe (Burdock and Carabin, 2004;Hippenstie et al, 2011). Medicinal plants are incorporated in poultry diets to replace synthetic products in order to stimulate or promote the effective use of feed nutrients which may subsequently result in more rapid body weigh gain, higher production rates and improved feed efficiency (Hippenstie et al, 2011).…”

Section: Introductionmentioning

confidence: 99%

Mineral Profile Evolution of Some Medicinal Plants With Antibacterial Effects

et al. 2016

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Individual minerals and antibacterial activity were investigated in 5 medicinal plants (pot marigold -Calendula officinalis, burdock -Arctium lappa, celandine -Chelidonium majus, basil-Ocimum basilicum, thyme -Thymus vulgaris) using Atomic Absorption Spectroscopy (AAS) technique and antibiogram method. The antibacterial susceptibility has been evaluated over 12 strains isolated from milk microflora, belonging to Staphylococcus, Vibrio, Serratia and Bacillus genera. The obtained results show the best antibacterial effect with Arctium lappa ethanol extracts, having inhibition areas of 6.3 to 17.5 mm, with an average of 9.0 mm and the highest determined mineral being Calcium.The results obtained open the prospect of using these medicinal plants as an alternative to be used for the control and cure of some mineral deficiencies or for preventing various diseases of the animals.

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Generally recognized as safe (GRAS): history and description

Cited by 173 publications

References 2 publications

Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the US

Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the US

Food and Dietary Supplement Package Labeling—Guidance from FDA's Warning Letters and Title 21 of the Code of Federal Regulations

Mineral Profile Evolution of Some Medicinal Plants With Antibacterial Effects

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