title: Safety assessment of mushrooms in dietary supplements by combining analytical data with in silico toxicology evaluation.
abstract: Despite growing popularity in dietary supplements, many medicinal mushrooms have not been evaluated for their safe human consumption using modern techniques. The multifaceted approach described here relies on five key principles to evaluate the safety of non-culinary fungi for human use: (1) identification by sequencing the nuclear ribosomal internal transcribed spacer (ITS) region (commonly referred to as ITS barcoding), (2) screening an extract of each fungal raw material against a database of known fungal metabolites, (3) comparison of these extracts to those prepared from grocery store-bought culinary mushrooms using UHPLCPDA-ELS-HRMS, (4) review of the toxicological and chemical literature for each fungus, and (5) evaluation of data establishing presence in-market. This weight-of-evidence approach was used to evaluate seven fungal raw materials and determine safe human use for each. Such an approach may provide an effective alternative to conventional toxicological animal studies (or more efficiently identifies when studies are necessary) for the safety assessment of fungal dietary ingredients.
authors.affiliation: Product Safety and Regulatory Affairs, New Chapter, Inc., 90 Technology Dr, Brattleboro, VT 05301, United States; Central Product Safety, The Procter and Gamble Company, Winton Hill Business Center, 6100 Center Hill Ave, Cincinnati, OH 45232, United States. Electronic address: vandermolen.k@pg.com.
authors.forename: Karen M
authors.initials: KM
authors.lastname: VanderMolen
authors.affiliation: Product Safety and Regulatory Affairs, New Chapter, Inc., 90 Technology Dr, Brattleboro, VT 05301, United States; Personal Health Care, The Procter and Gamble Company, Mason Business Center, 8700 Mason-Montogomery Rd, Mason, OH 45040, United States. Electronic address: little.j.6@pg.com.
authors.forename: Jason G
authors.initials: JG
authors.lastname: Little
authors.affiliation: Department of Chemistry and Biochemistry, University of North Carolina at Greensboro, Greensboro NC 27402, United States; Research and Development, Corporate Functions Analytical, The Procter & Gamble Company, Mason Business Center, 8700 Mason-Montogomery Rd, Mason, OH 45040, United States. Electronic address: sica.vp@pg.com.
authors.forename: Vincent P
authors.initials: VP
authors.lastname: Sica
authors.affiliation: Department of Chemistry and Biochemistry, University of North Carolina at Greensboro, Greensboro NC 27402, United States; Department of Medicinal Chemistry and Pharmacognosy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid 22110, Jordan. Electronic address: telimat@just.edu.jo.
authors.forename: Tamam
authors.initials: T
authors.lastname: El-Elimat
authors.affiliation: Department of Chemistry and Biochemistry, University of North Carolina at Greensboro, Greensboro NC 27402, United States. Electronic address: haraja@uncg.edu.
authors.forename: Huzefa A
authors.initials: HA
authors.lastname: Raja
authors.affiliation: Department of Chemistry and Biochemistry, University of North Carolina at Greensboro, Greensboro NC 27402, United States. Electronic address: nicholas_oberlies@uncg.edu.
authors.forename: Nicholas H
authors.initials: NH
authors.lastname: Oberlies
authors.affiliation: Research and Development, Corporate Functions Analytical, The Procter & Gamble Company, Mason Business Center, 8700 Mason-Montogomery Rd, Mason, OH 45040, United States. Electronic address: baker.tr@pg.com.
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Baker
authors.affiliation: Central Product Safety, Procter and Gamble Company Technical Centres Ltd, Egham, Surrey TW20 9NW, United Kingdom. Electronic address: mahony.c@pg.com.
authors.forename: Catherine
authors.initials: C
authors.lastname: Mahony
mesh_terms: D000363:Agaricales / Q000737:chemistry* / Q000235:genetics; D003198:Computer Simulation; D019587:Dietary Supplements / Q000009:adverse effects* / Q000633:toxicity; D006801:Humans; D014116:Toxicology / Q000379:methods*
keywords: Barcoding; Dietary ingredient; Fungi; Human safety; Supplements; UHPLC-HRMS