Safety assessment of the Cistanche tubulosa health food product Memoregain®: Genotoxicity and 28-day repeated dose toxicity test

The pharmacological effects of Cistanches Herba, known as "Ginseng of the desert", have been extensively studied. In this study, we aimed to assess the genotoxic and oral toxic effects of the Cistanche tubulosa health food product Memoregain® using in vitro and in vivo tests. Ames tests using five strains of Salmonella typhimurium showed no signs of increased reverse mutation upon exposure to Memoregain® up to a concentration of 5 mg/plate. Exposure of Chinese hamster ovary (CHO-K1) cells to Memoregain® did not increase the frequency of chromosomal aberrations in vitro. Moreover, Memoregain® treatment did not affect the proportions of immature to total erythrocytes or the number of micronuclei in the immature erythrocytes of ICR mice. Additionally, after 28-day repeated oral dose toxicity tests (0, 0.15, 0.3, and 0.5g/kg body weight) in rats, no observable adverse effects were found. These toxicological assessments supported the safety of Memoregain® for human consumption. •The Cistanche tubulosa extract product Memoregain® did not induce genotoxicity in Ames test up to 5 mg/plate.•Memoregain® did not induce chromosomal aberrations in CHO-K1 cells up to 2.5 mg/mL.•Memoregain® did not induce micronucleus formation in the bone marrow of mice up to 500 mg/kg.•In a 28-day repeated toxicity study, NOAEL for Memoregain® was greater than 500 mg/kg body weight/day in rats.