The Safety and Regulation of Natural Products Used as Foods and Food Ingredients

Division of Dietary Supplement Programs, Office of Nutrition, Labeling, and Dietary Supplements, College Park, Maryland 20740, USA.
Toxicological Sciences (Impact Factor: 3.85). 08/2011; 123(2):333-48. DOI: 10.1093/toxsci/kfr198
Source: PubMed


The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements.

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    • "An interest in use of herbs, botanicals and botanical-derived products as food ingredients is rapidly increasing worldwide for the purported benefits of attenuating medical problems and improving overall health status (Abdel-Rahman et al., 2011; Poppenga, 2002). A safety assessment of these ingredients is often limited to the documented history of safe food use without any additional animal toxicity or human clinical data required (Abdel-Rahman et al., 2011). Thus, it would appear that safety screening methods could be improved by collecting data on characterization of chemical-and species-specific toxicity. "
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    ABSTRACT: In vitro cell culture systems are a useful tool to rapidly assess the potential safety or toxicity of chemical constituents of food. Here, we investigated oxidative stress and organ-specific antioxidant responses by 7 potential dietary ingredients using canine in vitro culture of hepatocytes, proximal tubule cells (CPTC), bone marrow-derived mesenchymal stem cells (BMSC) and enterocyte-like cells (ELC). Cellular production of free radical species by denatonium benzoate (DB), epigallocatechin gallate (EPI), eucalyptol (EUC), green tea catechin extract (GTE) and sodium copper chlorophyllin (SCC), tetrahydroisohumulone (TRA) as well as xylitol (XYL) were continuously measured for reactive oxygen/nitrogen species (ROS/RNS) and superoxide (SO) for up to 24 hr. DB and TRA showed strong prooxidant activities in hepatocytes and to a lesser degree in ELC. DB was a weak prooxidant in BMSC. In contrast DB and TRA were antioxidants in CPTC. EPI was prooxidant in hepatocytes and BMSC but showed prooxidant and antioxidant activity in CPTC. SCC in hepatocytes (12.5mg/mL) and CPTC (0.78mg/mL) showed strong prooxidant and antioxidant activity in a concentration-dependent manner. GTE was effective antioxidant only in ELC. EUC and XYL did not induce ROS/RNS in all 4 cell types. SO production by EPI and TRA increased in hepatocytes but decreased by SCC in hepatocytes and ELC. These results suggest that organ-specific responses to oxidative stress by these potential prooxidant compounds may implicate a mechanism of their toxicities.
    Full-text · Article · Nov 2015 · Toxicology Letters
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    • "Recently, there have been reports that some traditional medical plants cause genotoxicity or cancer. The botanicals and herbal food supplements, which are generally recognized as safe, need to be set up legislative frameworks and guidance for risk assessment forwardly [20]. Delightedly, several organizations have undertaken the work and achieved results [21] [22]. "
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    ABSTRACT: Tremendous attentions have been attracted to the foods labeled with natural, green, organic, and nuisanceless conception of healthy diet. Therefore, it is of great significance to establish relative defining guidance for safe assessment of botanicals. Cyclocarya paliurus (Batal.) Iljinsk (family Cyclocaryaceae), called sweet tea tree, is a well-known edible and medicinal plant, which has been widely used in China as drug formulation for the treatment of hypertension and diabetes. Despite its benefits, no reports have been described on the safe assessment of C. paliurus leaves aqueous extract. In this study, we have conducted the genotoxicity assay (including Ames test, bone marrow polychromatic erythrocyte micronucleus test, and sperm abnormality test in mice) and traditional teratogenicity assay in rats (maternal toxicity, embryo toxicity, and teratogenicity test) to assess the genetic and teratogenic safety of aqueous extracts from C. paliurus leaves. Results of each assay show that the highest dose of C. paliurus leaves aqueous extract is considered relatively nonmutagenic and nonteratogenic, revealing that C. paliurus leaves possess safety and quality as a functional additional ingredient in food.
    Full-text · Article · Mar 2014 · The Scientific World Journal
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    ABSTRACT: Walnuts contain several antioxidant compounds which are thought to contribute to their biological properties. The present work investigated the various antioxidative activities of walnut (Juglans regia L.) green husks hydroalcoholic extract (W) and its effect on oxidation of LDL induced by CuSO 4 in vitro by monitoring the formation of conjugated dienes and thiobarbituric acid reactive substances (TBARS). It was demonstrated that total antioxidant capacity of W was 307±30 nmol of ascorbic acid equivalents/g W. The W showed remarkable scavenging activity on 2,2-diphenyl-picrylhydrazyl (DPPH) (IC 50 1819 μg/ml). Total
    Full-text · Article · Jan 2012
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