Botanical dietary supplement use is widespread and growing, therefore, ensuring the safety of botanical products is a public health priority. This commentary describes the mission and objectives of the Botanical Safety Consortium (BSC) - a public-private partnership aimed at enhancing the toolkit for conducting the safety evaluation of botanicals. This partnership is the result of a Memorandum of Understanding between the US FDA, the National Institute of Environmental Health Sciences, and the Health and Environmental Sciences Institute. The BSC serves as a global forum for scientists from government, academia, consumer health groups, industry, and non-profit organizations to work collaboratively on adapting and integrating new approach methodologies (NAMs) into routine botanical safety assessments. The objectives of the BSC are to: 1) engage with a group of global stakeholders to leverage scientific safety approaches; 2) establish appropriate levels of chemical characterization for botanicals as complex mixtures; 3) identify pragmatic, fit-for-purpose NAMs to evaluate botanical safety; 4) evaluate the application of these tools via comparison to the currently available safety information on selected botanicals; 5) and integrate these tools into a framework that can facilitate the evaluation of botanicals. Initially, the BSC is focused on oral exposure from dietary supplements, but this scope could be expanded in future phases of work. This commentary provides an overview of the structure, goals, and strategies of this initiative and insights regarding our first objectives, namely the selection and prioritization of botanicals based on putative toxicological properties.
CoQ10 supplementation has been promoted to prevent and/or reduce symptoms of several degenerative diseases including arteriosclerosis and hypertension. Natural sources of CoQ10 include certain vegetable oils, meats, nuts, and fish. Marine oils derived from cod liver, tuna and calamari were investigated as unique natural sources of CoQ10; however, analysis was problematic due to the complex sample matrix. After unsuccessful attempts measuring CoQ10 using a method designed for vegetable oils, a HPLC‐UV method was developed to determine CoQ10 in marine oils. Sample preparation included saponification followed by solvent extraction. Of the seven commercially available marine oil supplements measured calamari oil had the highest levels of CoQ10 (>;200 mg/kg).These results were confirmed using a separately developed quantitative LC‐MS (Q‐TOF) method which utilized isotopically labeled CoQ10 as an internal standard. Our results demonstrate that a 5mL serving of calamari oil provides approximately 20% of the average daily intake of CoQ10.
Beets (Beta vulgaris) are large edible tap roots vegetables belonging to the chenopod family. In addition to being a good source of essential micronutrients and minerals, beets also contain high levels of nitrates. Diets high in beet and nitrates have been demonstrated to improve exercise capacity, muscle contractility, and blood pressure. While these results have been replicated several times little is known about the mechanism of action. In this study we investigated grip strength and metabolomic changes in response to diets containing sodium nitrate, and beets providing nitrates at 5.5, 2.75, 1.37 mmol/g BW/day. Grip strength studies demonstrated a dose response improvement in the mice eating the beet diet, with a statistically significant peak grip strength improvement of 25%. These results are consistent with previous reports that beet juice improves muscle contractility. Untargeted metabolomic analysis in two separate studies indicated an upward trend (p=0.06) of plasma sphingosine 1‐phospate (S1P) concentrations in mice fed a beet diet (5.5mmol/gBW/day) compared with mice fed a control diet. Increased S1P has been previously correlated with exercise performance, muscle repair and activation of muscle stem cells. Overall these results suggest that high‐nitrate foods such as beets may improve muscle contractility through a mechanism of action which may include S1P and targets under its influence.
Interest in botanicals, particularly as dietary supplement ingredients, is growing steadily. This growth, and the marketing of new ingredients and combination products as botanical dietary supplements underscores the public health need for a better understanding of potential toxicities associated with use of these products. This article and accompanying template outline the resources to collect literature and relevant information to support the design of botanical toxicity studies. These resources provide critical information related to botanical identification, characterization, pre-clinical and clinical data, including adverse effects and interactions with pharmaceuticals. Toxicologists using these resources should collaborate with pharmacognosists and/or analytical chemists to enhance knowledge of the botanical material being tested. Overall, this guide and resource list is meant to help locate relevant information that can be leveraged to inform on decisions related to toxicity testing of botanicals, including the design of higher quality toxicological studies.
Zusammenfassung Die Verwendung von pflanzlichen Heilmitteln und Nahrungsergänzungsmitteln ist weit verbreitet. In vielen Ländern der Welt weisen die Verkaufszahlen auf eine steigende Beliebtheit dieser Produkte hin. Daher ist die Gewährleistung der Sicherheit von pflanzlichen Produkten eine Priorität der öffentlichen Gesundheit. Dieser Artikel beschreibt die Aufgaben und Ziele des Botanical Safety Consortiums (BSC) – einer öffentlich-privaten Partnerschaft. Diese Partnerschaft ist das Ergebnis einer Absichtserklärung zwischen der Gesundheitsbehörde der USA (FDA), dem National Institute of Environmental Health Sciences (NIEHS, eine Unterabteilung des Ministeriums für Gesundheitspflege und Soziale Dienste der Vereinigten Staaten) und einer gemeinnützigen Organisation, dem Health and Environmental Sciences Institute (HESI). Das BSC dient als globales Forum für Wissenschaftler aus Regierungen, Hochschulen, Gesundheitsfürsorgegruppen, Industrie und gemeinnützigen Organisationen, um gemeinsam an der Anpassung und Integration neuer Ansatzmethoden (NAM) für routinemäßige Sicherheitsbewertungen von Pflanzenstoffen zu arbeiten. Die Ziele des BSC sind: 1) eine weltweite Zusammenarbeit, um existierende Sicherheitstests besser zu nutzen; 2) geeignete Methoden der chemischen Charakterisierung von Pflanzenstoffen festzusetzen; 3) pragmatische, zweckmäßige NAM zu identifizieren, um die Sicherheit von pflanzlichen Inhaltsstoffen und Fertigpräparaten zu bewerten; 4) eine Bewertung dieser Methoden mittels Vergleich mit derzeit verfügbaren Informationen zur Sicherheit von ausgewählten Pflanzenstoffen; 5) und die Integration dieser NAM in ein System, das die Bewertung von Pflanzenstoffen erleichtern kann. Der Schwerpunkt des BSC liegt zunächst auf Phytopharmaka und Nahrungsergänzungsmitteln, welche oral verabreicht werden, jedoch kann dieser Ansatz in zukünftigen Arbeitsphasen erweitert werden. Dieser Artikel beinhaltet einen Überblick über die Struktur, Ziele und Strategien dieser Initiative und erläutert die ersten Ziele, nämlich die Auswahl der Test-Pflanzenstoffe, basierend auf publizierten toxikologischen Daten.
Importance of the field: Disrupted l-methionine (Met) metabolism can lead to hepatic, neurological and cardiovascular dysfunction in humans. Aberrant methyl group flux likely contributes to the development of these pathologies, but when patients also become hypermethionemic, additional toxicological mechanisms may be relevant.
α‐carotene has been identified as having anti‐oxidant potential, anti‐carcinogenic properties, and associations with reduced allcause mortality. Pumpkins have been reported to have high concentrations of α‐carotene. To confirm this, we examined the α‐carotene concentration in five different colored varieties of pumpkins: Rouge Vif D'Etampes (red), Wolf (orange), Long Island Cheesewheel (Pink), Musque de Provence (Green), and Valenciano (white). The closer a pumpkins skin colors was to the red spectrum the greater their total carotenoid content. However, the further away pumpkins were from the red spectrum the higher their α‐carotene content. The green Musque de Provence and pink Cheesewheel pumpkins also appears to be a better sources for alpha‐carotene because of a higher ratio between α and β carotene, which means excessive amounts of β would not have to be consumed to achieve a good intake of α. Finally, the pumpkins highest in α‐carotenoids have greater potential for activation of ARE promoter elements which are known to control anti‐oxidant genes, is in‐line with other research reports of enhanced antioxidant potential for α‐carotene. These results suggest green Musque de Provence and pink Cheesewheel pumpkins are good sources for α‐carotene.
α‐Retinol (αR) is a structural analog of retinol that does not bind to serum retinol‐binding protein (RBP4). In this study, α‐retinyl acetate (αRA) was synthesized and given orally (35 μmol) to vitamin A (VA)‐deficient lactating sows (n = 11) as a tracer for RBP4‐independent retinol transport and tissue uptake. Serum αR concentrations peaked at 2 h (70 ± 23 nmol/L, mean ± SEM) primarily as four distinct α‐retinyl esters. Peak αR milk concentrations were detected at 7.5 h (371 ± 83 nmol/L). Sow livers collected 25 d post‐dose contained a high percentage of the αR dose (52 ± 15%, mean ± SD) likely due to the inability of RBP4 to transport αR from the liver. Nursing piglets (n = 17) killed 3 days after the αRA‐dosing of sows (n = 5) had 2.2 ± 0.7% of the αRA dose in their livers, which correlated to an estimated 15–26% transfer of the αRA dose from individual sows to their litters. Total liver retinol levels for all sows and piglets were <0.1 μmol/g liver confirming their VA‐deficient status. RBP4‐independent mechanisms play a significant role in the uptake of retinol into milk when single, large doses of retinyl acetate are given to VA‐deficient lactating women in developing nations. αR has great potential as a tracer for RBP4‐independent retinoid bioprocesses. Supported by USDA‐NRI 2007‐35200‐17729.
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