2016
DOI: 10.3390/ijms17030331
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Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States

Abstract: In the United States (US), the risk of hepatotoxicity linked to the widespread use of certain herbal products has gained increased attention among regulatory scientists. Based on current US law, all dietary supplements sold domestically, including botanical supplements, are regulated by the Food and Drug Administration (FDA) as a special category of foods. Under this designation, regulatory scientists do not routinely evaluate the efficacy of these products prior to their marketing, despite the content variabi… Show more

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Cited by 90 publications
(102 citation statements)
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“…This contrasts with intrinsic DILI, such as that seen with acetaminophen, where the relationship between high doses of the drug and liver injury is predictable 10. Herbal-related DILI has been increasing in frequency over the last decade in the USA, accounting for 20% of DILI cases in 2013,9 and an even higher proportion of cases in countries where herbal use is more common 63 64. Known risk factors for idiosyncratic DILI, including advanced age, female gender, alcohol consumption and the consumption of more than 100 mg/day of the offending agent,10 64 could likely have been met in this case, with the exception of alcohol use, since the majority of US turmeric DS deliver more than 100 mg of curcuminoids 6.…”
Section: Discussionmentioning
confidence: 99%
“…This contrasts with intrinsic DILI, such as that seen with acetaminophen, where the relationship between high doses of the drug and liver injury is predictable 10. Herbal-related DILI has been increasing in frequency over the last decade in the USA, accounting for 20% of DILI cases in 2013,9 and an even higher proportion of cases in countries where herbal use is more common 63 64. Known risk factors for idiosyncratic DILI, including advanced age, female gender, alcohol consumption and the consumption of more than 100 mg/day of the offending agent,10 64 could likely have been met in this case, with the exception of alcohol use, since the majority of US turmeric DS deliver more than 100 mg of curcuminoids 6.…”
Section: Discussionmentioning
confidence: 99%
“…In the U.S. (and other countries) chlorophyll products are sold as dietary supplements, which are not regulated by the FDA. Therefore, no product quality and efficacy evaluation is require prior to marketing 81 .…”
Section: Contribution Of Hemorrhagic or Thrombotic Riskmentioning
confidence: 99%
“…Liver injury by drugs, herbs, and dietary supplements (HDS) was comprehensively reviewed in 2016 and 2017, with extensive information provided in a HDS case series published in 2017 . These topics were also discussed in a special issue on “Drug, Herb, and Dietary Supplement Hepatotoxicity” in 2016 . Liver injuries related to herbs and dietary supplements (DS) represent a major clinical and regulatory challenge.…”
Section: Introductionmentioning
confidence: 99%