title: The safety and regulation of natural products used as foods and food ingredients.
abstract: 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.
authors.affiliation: Division of Dietary Supplement Programs, Office of Nutrition, Labeling, and Dietary Supplements, College Park, Maryland 20740, USA.
authors.forename: Ali
authors.initials: A
authors.lastname: Abdel-Rahman
authors.forename: Njwen
authors.initials: N
authors.lastname: Anyangwe
authors.forename: Louis
authors.initials: L
authors.lastname: Carlacci
authors.forename: Steve
authors.initials: S
authors.lastname: Casper
authors.forename: Rebecca P
authors.initials: RP
authors.lastname: Danam
authors.forename: Evaristus
authors.initials: E
authors.lastname: Enongene
authors.forename: Gladys
authors.initials: G
authors.lastname: Erives
authors.forename: Daniel
authors.initials: D
authors.lastname: Fabricant
authors.forename: Ramadevi
authors.initials: R
authors.lastname: Gudi
authors.forename: Corey J
authors.initials: CJ
authors.lastname: Hilmas
authors.forename: Fred
authors.initials: F
authors.lastname: Hines
authors.forename: Paul
authors.initials: P
authors.lastname: Howard
authors.forename: Dan
authors.initials: D
authors.lastname: Levy
authors.forename: Ying
authors.initials: Y
authors.lastname: Lin
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Moore
authors.forename: Erika
authors.initials: E
authors.lastname: Pfeiler
authors.forename: T Scott
authors.initials: TS
authors.lastname: Thurmond
authors.forename: Saleh
authors.initials: S
authors.lastname: Turujman
authors.forename: Nigel J
authors.initials: NJ
authors.lastname: Walker
mesh_terms: D000818:Animals; D001688:Biological Products / Q000592:standards / Q000633:toxicity*; D005502:Food / Q000592:standards; D005503:Food Additives / Q000009:adverse effects* / Q000592:standards; D059022:Food Safety / Q000379:methods*; D005523:Food Supply; D006801:Humans; D007881:Legislation, Food; D051379:Mice; D011640:Public Policy / Q000331:legislation & jurisprudence*; D051381:Rats; D012926:Social Control, Formal
chemical_list: D001688:Biological Products; D005503:Food Additives