Ten years post-GAO assessment, FDA remains uninformed of potentially harmful GRAS substances in foods

Faustman, C.; Aaron, Daniel; Negowetti, Nicole E.; Leib, Emily Broad

doi:10.1080/10408398.2020.1756217

Cited by 13 publications

(5 citation statements)

References 23 publications

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“…The agreement between USDA and FDA ( USDA, 2019 ) currently calls for the latter to “Conduct premarket consultation processes to evaluate production materials/processes and manufacturing controls, to include oversight of tissue collection, cell lines and banks, and all components and inputs.” This would appear to parallel the process used for new bioengineered plant varieties ( Watson, 2019 ). As such, the differentiation of cell-based meat as a food additive or generally recognized as safe (GRAS) substance as previously hypothesized ( Liu and Gasteratos, 2019 ), and the expected controversy that would surround such a debate ( Faustman et al, 2020 ) does not appear likely to occur. More specific details of how each agency will apply its regulatory authority within their scope of responsibility for cell-based meat manufacture and processing remain to be communicated but there is likely to be some controversy that develops ( Johnson, 2019 ; Sachs and Kettenmann, 2019 ; Watson, 2019 ).…”

Section: Regulation As a Foodmentioning

confidence: 96%

Cell-based meat: the need to assess holistically

Faustman

Hamernik

Looper

et al. 2020

Journal of Animal Science

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Proof-of-principle for large-scale engineering of edible muscle tissue, in vitro, was established with the product’s introduction in 2013. Subsequent research and commentary on the potential for cell-based meat to be a viable food option and potential alternative to conventional meat have been significant. While some of this has focused on the biology and engineering required to optimize the manufacturing process, a majority of debate has focused on cultural, environmental, and regulatory considerations. Animal scientists and others with expertise in muscle and cell biology, physiology, and meat science have contributed to the knowledge base that has made cell-based meat possible and will continue to have a role in the future of the new product. Importantly, the successful introduction of cell-based meat that looks and tastes like conventional meat at a comparable price has the potential to displace and/or complement conventional meat in the marketplace.

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Section: Regulation As a Foodmentioning

confidence: 96%

Cell-based meat: the need to assess holistically

Faustman

Hamernik

Looper

et al. 2020

Journal of Animal Science

Self Cite

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“…Intriguingly, a recent call was to reevaluate the GRAS definition allocated to various processed food additive ingredients. More reliable and updated approaches are offered to enzyme and other food nutritional categories for a more scientifically rigorous, sound and transparent application of the GRAS concept [ 27 , 28 , 29 , 30 , 31 , 32 ]. Moreover, a call to label, declare utilization and ensure consumer transparency regarding GEM enzymes is expressed in multiple scientific publications [ 28 , 33 , 34 , 35 ].…”

Section: Numerous Harmful Mobile Genetic Elements (Mges) Can Be Trans...mentioning

confidence: 99%

The Potential Harmful Effects of Genetically Engineered Microorganisms (GEMs) on the Intestinal Microbiome and Public Health

Lerner,

Benzvi,

Vojdani

2024

Microorganisms

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Gut luminal dysbiosis and pathobiosis result in compositional and biodiversified alterations in the microbial and host co-metabolites. The primary mechanism of bacterial evolution is horizontal gene transfer (HGT), and the acquisition of new traits can be achieved through the exchange of mobile genetic elements (MGEs). Introducing genetically engineered microbes (GEMs) might break the harmonized balance in the intestinal compartment. The present objectives are: 1. To reveal the role played by the GEMs’ horizontal gene transfers in changing the landscape of the enteric microbiome eubiosis 2. To expand on the potential detrimental effects of those changes on the human genome and health. A search of articles published in PubMed/MEDLINE, EMBASE, and Scielo from 2000 to August 2023 using appropriate MeSH entry terms was performed. The GEMs’ horizontal gene exchanges might induce multiple human diseases. The new GEMs can change the long-term natural evolution of the enteric pro- or eukaryotic cell inhabitants. The worldwide regulatory authority’s safety control of GEMs is not enough to protect public health. Viability, biocontainment, and many other aspects are only partially controlled and harmful consequences for public health should be avoided. It is important to remember that prevention is the most cost-effective strategy and primum non nocere should be the focus.

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“…They followed the manufacturers' declarations on mTG being non-toxic, safe, non-allergenic, non-immunogenic and non-pathogenic for public health [3,12,28]. The topic of industrial enzyme production, usage and safety of genetically modified microorganisms is the subject of intense debate, while continental and national discrepancies are wide [93][94][95][96][97][98][99][100][101]. Multiple issues are raised and the antibiotic resistance gene is of concern [85,[94][95][96].…”

Section: Should Mtg Usage Be Labeled and Declared On Food Products?mentioning

confidence: 99%

“…The FDA's GRAS category has evolved during the last decades [97,98] and attracted quite a lot of attention from scientists, regulators, policy-makers, professional and social media, and non-governmental organizations [99]. Critical opinions were expressed, including a recent one on the lack of a "master list of all GRAS chemicals used in food, nor did the FDA request the authority to do so from Congress" [100]. Another suggested inadequate "scientifically sound, rigorous, and transparent application of the GRAS concept" [101].…”

Section: Should the Customers Be Warned For A Potential Health Risk Of Mtg Consumption?mentioning

confidence: 99%

Microbial Transglutaminase Is a Very Frequently Used Food Additive and Is a Potential Inducer of Autoimmune/Neurodegenerative Diseases

Lerner

Benzvi

2021

Toxics

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Microbial transglutaminase (mTG) is a heavily used food additive and its industrial transamidated complexes usage is rising rapidly. It was classified as a processing aid and was granted the GRAS (generally recognized as safe) definition, thus escaping full and thorough toxic and safety evaluations. Despite the manufacturers claims, mTG or its cross-linked compounds are immunogenic, pathogenic, proinflammatory, allergenic and toxic, and pose a risk to public health. The enzyme is a member of the transglutaminase family and imitates the posttranslational modification of gluten, by the tissue transglutaminase, which is the autoantigen of celiac disease. The deamidated and transamidated gliadin peptides lose their tolerance and induce the gluten enteropathy. Microbial transglutaminase and its complexes increase intestinal permeability, suppresses enteric protective pathways, enhances microbial growth and gliadin peptide’s epithelial uptake and can transcytose intra-enterocytically to face the sub-epithelial immune cells. The present review updates on the potentially detrimental side effects of mTG, aiming to interest the scientific community, induce food regulatory authorities’ debates on its safety, and protect the public from the mTG unwanted effects.

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Ten years post-GAO assessment, FDA remains uninformed of potentially harmful GRAS substances in foods

Cited by 13 publications

References 23 publications

Cell-based meat: the need to assess holistically

Cell-based meat: the need to assess holistically

The Potential Harmful Effects of Genetically Engineered Microorganisms (GEMs) on the Intestinal Microbiome and Public Health

Microbial Transglutaminase Is a Very Frequently Used Food Additive and Is a Potential Inducer of Autoimmune/Neurodegenerative Diseases

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