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Consumer Views on Health Issues Arising from Food Products
Published in Megh R. Goyal, Preeti Birwal, Santosh K. Mishra, Phytochemicals and Medicinal Plants in Food Design, 2022
Harita R. Desai, Murlidhar Meghwal
For evaluation of the general safety of such chemicals to be used as food additives, the Food and Drug Administration (US FDA) has defined certain assessment parameters. Two important parameters that aid to gauge the safety of food additives are: determination of Acceptable Daily Intake (ADI) and Estimated Daily Intake (EDI). These two assessments are affected by several factors, such as consumer preferences, changes in consumer choice over changing health conditions, growing technological advances on food processing industry, changing diet plan with age and region, advancement in toxicological studies [49]. The US Food and Drug Act of 1906 prohibits food adulteration by toxic unsafe products [11]. As per code of US Federal Regulations, safety is defined as “an assurance in the observation of food scientists that the food sample under study does not show any unwanted effects for the proposed use.”
The FDA New Animal Drug Approval Process
Published in Rebecca A. Krimins, Learning from Disease in Pets, 2020
Jacob Michael Froehlich, Alice Ignaszewski, Anna O’Brien
For drugs used in food-producing animals, the HFS technical section is comprised of three parts: toxicology; residue chemistry, which includes the analytical method for detecting residues; and microbial food safety. Toxicology generally evaluates a series of studies such as testing for systemic toxicity, developmental and reproductive toxicity, genotoxicity, and when applicable, carcinogenicity, effects on human intestinal flora, neurotoxicity, and immunotoxicity. Information from these studies is used to establish the acceptable daily intake (ADI), which most often will be set on the basis of the drug’s toxicological, microbiological, or pharmacological properties. This value, usually expressed in micrograms or milligrams of the total drug residues per kilogram of body weight per day, represents the daily intake of drug residue in animal tissue that may be consumed during the entire life of a human without adverse effects or harm to the health of the consumer. This ADI, together with food consumption values for edible tissues, is then used to determine safe concentrations. The safe concentration is the amount of total residue of a new animal drug that can be consumed from each edible tissue every day for up to the lifetime of a human without exposing the human to residues in excess of the ADI. Safe concentrations, expressed as parts per million (ppm) or parts per billion (ppb), are used for tolerance determinations.
Vitamin C (Ascorbic Acid)
Published in Luke R. Bucci, Nutrition Applied to Injury Rehabilitation and Sports Medicine, 2020
The results of recent studies have clarified the safety of ascorbate supplementation in humans.673–675 An acceptable daily intake (ADI) with no risk of harm for long-term ingestion is 1050 mg/70 kg/d, as determined by the Joint Expert Committee on Food Additives of the FAO/WHO.675 Consensus of recent reviews has found excellent safety from 1 to 5 g/d administered in divided doses. Even doses of 10 g ascorbate daily are not considered to be a serious health risk for humans. Previously, high doses of ascorbate were hypothesized to increase formation of oxalate stones in urine, destroy vitamin B12 in the gut, increase urine urate levels, increase toxicity of iron, increase mutagenicity, and induce rebound scurvy. There has been no human clinical evidence supporting these hypotheses, as determined by recent studies which have specifically addressed these concerns.673–675 The only practical safety concerns for ascorbate are gastrointestinal distress and diarrhea (osmotic) from very large single doses (ranges from 2 to 20 g among individuals) or very large daily doses (over 10 g daily). A possible concern is the coadministration of large doses of ascorbate with aluminum-containing products (antacids) in renal failure, since ascorbate may enhance intestinal uptake of aluminum, which is nephrotoxic.674 Otherwise, daily doses of 1 to 5 g of ascorbate should be considered for future clinical trials.
Prenatal exposure to artificial food colorings alters NMDA receptor subunit concentrations in rat hippocampus
Published in Nutritional Neuroscience, 2021
Duygu Kumbul Doguc, Firdevs Deniz, İlter İlhan, Esin Ergonul, Fatih Gultekin
Food colorings are added to food to restore the natural colors lost in processing and also to impart, preserve, or enhance the color of food to produce esthetically and psychologically attractive products [1,2]. Food colorings are classified as artificial (synthetic) and natural, depending on their source [2]. The synthetic colors widely used in the food industry, referred to as artificial food coloring additives (AFCAs), have been implicated in the development of neurobehavioral disorders in children [3,4]. The adverse effects of AFCAs on children’s behavior was first proposed in 1975 by Feingold, who theorized that hypersensitivity to food additives, especially AFCAs, may be the underlying cause of the hyperactivity observed in some children [5,6]. McCann et al. published a study in 2007 which brought about renewed interest in the hypothesis of AFCAs’ adverse effect on neurobehavior [7]. Other studies have supported a link between long-term or repeated ingestion of AFCAs and childhood behavioral hyperactivity [8–10]. However, none of these studies have led to a consensus on a particular AFCA or any other food additives, which are periodically re-evaluated by a scientific committee of the European Food Safety Authority (EFSA) to determine their safety and acceptable daily intake (ADI) values.
Relevance of animal studies in the toxicological assessment of oil and wax hydrocarbons. Solving the puzzle for a new outlook in risk assessment
Published in Critical Reviews in Toxicology, 2021
Juan-Carlos Carrillo, Dirk Danneels, Jan Woldhuis
The long history and use of petroleum-derived oils and waxes in the industry has generated a significant amount of data followed by a no less rigorous number of regulatory evaluations to ensure safe use. Although alkanes are relatively simple and non-reactive chemicals, their safety assessment as complex hydrocarbon products (i.e. oils and waxes) has not been without stumbling blocks and controversies, especially the discussion about the relevance of the F-344 rat for the assessment of mineral waxes and oils since the 90’s. This has led to the situation where acceptable daily intake – ADI – values have been set or revoked based on a complicated and puzzling data base of chemical compositions, toxicological endpoints, internal and external dose differences, rat strain differences and opinions on the relevance of these for human risk assessment. An extensive literature review on long-term toxicity of mineral waxes and oils has been recently published which provides a novel visualization of the data points and a general insight into two key points namely, hepatic granuloma and alkane accumulation (Pirow et al. 2019).
An overview of current practices for regulatory risk assessment with lessons learnt from cosmetics in the European Union
Published in Critical Reviews in Toxicology, 2021
Emma Arnesdotter, Vera Rogiers, Tamara Vanhaecke, Mathieu Vinken
For a toxicological response to occur following exposure to non-genotoxic compounds, the dose needs to exceed the capacity of homeostatic adaptive and cytoprotective processes (Dybing et al. 2002; Edler et al. 2002). It is assumed that there is a dose where non-genotoxic compounds are not likely to induce adverse effect(s), which constitutes the rationale for HBGV derivation. Different terminology is used depending on the chemical sector and the legislative framework (Table 2). However, the derivation is identical, whereby the HBGV is the ratio of the POD divided by the UFs (WHO/IPCS 2009c). Probably the most known HBGV is the acceptable daily intake (ADI), which is commonly used for food additives. The ADI was introduced in the late 1950s (Truhaut 1991) and defined as the dietary daily intake of a chemical which, during an entire lifetime, appears to be without considerable risk based on all known facts at the time. It should be stressed that HBGVs only consider health risks based on scientific data and are not legally binding, while limit values are specified in legislation and include both technical and economic aspects (WHO/IPCS 1994, 2009f).