Establishment of a risk assessment method for herbal supplement products based on the concept of food additives

2023 Fiscal Year Final Research Report

• Project/Area Number: 19K15795
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 38050:Food sciences-related
• Research Institution: Jumonji University
• Principal Investigator: Yamazaki Yuko 十文字学園女子大学, 人間生活学部, 准教授 (70518117)
• Project Period (FY): 2019-04-01 – 2024-03-31
• Keywords: ハーブサプリメント製品 / リスク評価 / 薬物代謝酵素

Outline of Final Research Achievements

To ensure the safety of herbal supplements (HS), individual evaluation for each product is important, reflecting their diversity. Therefore, based on the safety evaluation methods for food additives, we developed and named an animal test suitable for the individual evaluation of HS: the Suggested Daily Intake-Based Safety Evaluation (SDI-SE). The SDI-SE is a back-calculation analog of the acceptable daily intake (ADI) derivation; that is, rats were administered individual herbal supplement products at 100 times SDI for human use equivalents per body weight and signs of adverse effects on the gene expression of the hepatic drug metabolizing enzyme cytochrome P450 (CYP).
To verify the usefulness of the evaluation method, the SDI-SE was applyed to the butterbur and the coleus forskohlii products, and the CYP induction effect on the liver was analyzed to detect differences in the effects between products.　In addition, CYP-inducing ingredient was examined by component analysis.

Free Research Field

食品科学

Academic Significance and Societal Importance of the Research Achievements

これまで，SDI-SEを実施してきた複数のHSについて，肝臓への作用を4つのカテゴリー（Ⅰ：肝肥大とCYP1A1の誘導，Ⅱ：肝肥大と医薬品代謝に関わるCYPの誘導，Ⅲ：肝肥大なしで，軽度なCYPの誘導，Ⅳ：肝臓への影響なし）に整理し，各カテゴリーの製品につき，安全性確保の方針も提案した．
この評価を行い肝肥大やCYPを誘導するものは，一日推奨量の変更，薬物相互作用のラベル明記，CYPを誘導する成分量の調節など，製品管理の見直しや商品開発等に活用できると考える．SDI-SEに基づく情報はHSの安全性確保に有用である．