Application to Butterbur Products of a Suggested Daily Intake-Based Safety Evaluation of Individual Herbal Supplements with Cytochrome P450 Expression as a Major Index

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  • HASHIDA Hiroko
    Department of Food and Nutritional Sciences, Graduate School of Human Life Sciences, Jumonji University Graduate School
  • KURAWAKA Misaki
    Department of Food and Nutritional Sciences, Graduate School of Human Life Sciences, Jumonji University Graduate School
  • TATEHANA Haruka
    Department of Food and Nutritional Sciences, Graduate School of Human Life Sciences, Jumonji University Graduate School
  • ARITA Anna
    Department of Health and Nutrition, Faculty of Human Life, Jumonji University
  • SASAKI Naho
    Department of Health and Nutrition, Faculty of Human Life, Jumonji University
  • SHIMURA Fumio
    Department of Food and Nutritional Sciences, Graduate School of Human Life Sciences, Jumonji University Graduate School
  • YAMAZAKI Yuko
    Department of Food and Nutrition, Faculty of Human Life, Jumonji University

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<p>The present paper first proposes a method for ensuring the safety of commercial herbal supplements, termed the suggested daily intake-based safety evaluation (SDI-based safety evaluation). This new method was inspired as a backward analog of the acceptable daily intake (ADI) derivation from the no observed adverse effect level (NOAEL), the basis of food additive risk analysis; namely, rats are dosed with individual herbal supplement products at the SDI for human use multiplied by 100 (the usual uncertainty factor value) per body weight for 8 d. The primary endpoint is the sign of adverse effects on liver, especially gene expression of cytochrome P450 (CYP) isoforms. The proposed method was then applied to three butterbur (Petasites hybridus) products without pyrrolizidine alkaloids but lacking clear safety information. Results showed that two oily products markedly enhanced the mRNA expression of CYP2B (>10-fold) and moderately enhanced that of CYP3A1 (<4-fold) with liver enlargement. These products also caused the renal accumulation of alpha 2-microglobulin. One powdery product showed no significant effect on liver and kidney. The large difference in effects of products was due to the difference in chemical composition revealed by liquid chromatography–mass spectroscopy. The oily and the powdery products required attention in terms of safety and effectiveness, respectively. Finally, the results from the SDI-based safety evaluation of butterbur and other herbal supplement products were grouped into four categories and cautionary notes were discussed. The SDI-based safety evaluation of their products by herbal supplement operators would contribute to safe and secure use by consumers.</p>

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