The use of botanical ingredients continues to increase across multiple commercial goods categories in large part due to consumer demand. Botanical ingredients and/or individual phytochemical constituents are added to foods and beverages, cosmetics, dietary supplements (including prebiotics and probiotics), and herbal medicines. Most natural ingredients are included in commercial products as complex mixtures; however, isolated individual constituents are sometimes used. Foods, cosmetics, dietary supplements, and herbal medicines are regulated very differently from conventional drugs; and pre-market review by regulatory agencies of these types of products is often not a requirement.

Additionally, there is an overwhelming perception by consumers that natural ingredients are inherently safe. Resource efficient in silico and in vitro tools are needed that can accommodate complex mixtures represented by botanical ingredients. The availability of in silico and in vitro models for predicting disposition (e.g. absorption, metabolism, bioavailability), and toxicity across biological endpoints could be incorporated into hazard identification and risk assessments of botanical ingredients. The availability of in vitro models with in vivo/clinical predictive power to manufacturers of such products, coupled with regulatory acceptance of the data generated from such systems would help ensure the safety of botanical-based products in the marketplace.

Papers Targeted (Topics will include):

• Use of in silico and in vitro tools and systems for assessing or predicting toxicity of botanical ingredients including food/beverage ingredients, cosmetics, botanicals, herbal medicines, etc.
• Use of in silico and in vitro tools and systems for evaluating the disposition of botanical ingredients/constituents including models for studying absorption, metabolism, botanical-drug or botanical-botanical interactions, and bioavailability
• In vitro models for studying toxicity MoA of botanical ingredients
• Utility of in vitro models for studying complex mixtures represented by botanical extracts
• Application of next generation toxicology methods into evaluation of botanical and incorporation of data into hazard identification and risk assessments for botanicals
• Perspective on regulatory needs for acceptance of data generated from alternative tools and models into regulatory evaluations of regulated products containing botanicals

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