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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Available from: Scott Thurmond, Jul 30, 2014
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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.
    The Scientific World Journal 03/2014; 2014(4):498134. DOI:10.1155/2014/498134 · 1.73 Impact Factor
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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
    01/2012; 2(6). DOI:10.1080/22311866.2012.10719141
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    ABSTRACT: Assessment of safety for a food or dietary ingredient requires determination of a safe level of ingestion compared to the estimated daily intake from its proposed uses. The nature of the assessment may require the use of different approaches, determined on a case-by-case basis. Natural products are chemically complex and challenging to characterize for the purpose of carrying out a safety evaluation. For example, a botanical extract contains numerous compounds, many of which vary across batches due to changes in environmental conditions and handling. Key components integral to the safety evaluation must be identified and their variability established to assure that specifications are representative of a commercial product over time and protective of the consumer; one can then extrapolate the results of safety studies on a single batch of product to other batches that are produced under similar conditions. Safety of a well-characterized extract may be established based on the safety of its various components. When sufficient information is available from the public literature, additional toxicology testing is not necessary for a safety determination on the food or dietary ingredient. This approach is demonstrated in a case study of an aqueous extract of cranberry (Vaccinium macrocarpon Aiton) leaves.
    Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 04/2012; 50(9):3150-65. DOI:10.1016/j.fct.2012.03.075 · 2.90 Impact Factor
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