アメリカのCBD法規制–最新情報

  1. FDA(米食品医薬品局)
    厳しいスタンスであることは概要に記載した通り。
  2. USDA(米農業省)
    農産物を出荷する前に、THCが0.3%未満であるかを検査するフローを検討中
  3. ProCBDの巻き返し
    薬事法改正 ⇒ CBDがサプリメントに該当することを明確にする(修正法案HR5587)
    【法案抜粋】
    If passed in its current form, HR 5587 would amend the FDCA’s definition of dietary supplement (21 U.S.C. 321(ff)(3)(B)) as shown below in bold:
    The term “dietary supplement” does not include—
    (i) an article (other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance) that is approved as a new drug under section 355 of this title, certified as an antibiotic under section 357 of this title, or licensed as a biologic under section 262 of title 42, or
    (ii) an article (other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance) authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public…