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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 variability and phytochemical complexity that often characterizes them. Nonetheless, there has been notable progress in the development of advanced scientific methods to qualitatively and quantitatively measure ingredients and screen for contaminants and adulterants in botanical products when hepatotoxicity is recognized.

SUBMITTER: Avigan MI

PROVIDER: S-EPMC4813193 | biostudies-other | 2016 Mar

REPOSITORIES: biostudies-other

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Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States.

Avigan Mark I MI Mozersky Robert P RP Seeff Leonard B LB

International journal of molecular sciences 20160303 3

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 ...[more]

PMID: 26950122

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Project description:BackgroundMany cancer patients initiate dietary supplement use after cancer diagnosis. How dietary supplement use contributes to the total nutrient intake among cancer survivors as compared with individuals without cancer needs to be determined.ObjectivesWe aimed to evaluate nutrient intakes from dietary supplements among cancer survivors in relation to their total nutrient intake and compare those with individuals without cancer.MethodsWe evaluated the prevalence, dose, and reason for using dietary supplements among 2772 adult cancer survivors and 31,310 individuals without cancer who participated in the NHANES 2003-2016.ResultsCancer survivors reported a higher prevalence of any (70.4% vs. 51.2%) and multivitamin/mineral (48.9% vs. 36.6%) supplement use and supplement use of 11 individual vitamins and 8 minerals than individuals without cancer. Overall, cancer survivors had significantly higher amounts of nutrient intake from supplements but lower nutrient intakes from foods for the majority of the nutrients. Compared with individuals without cancer, cancer survivors had a higher percentage of individuals with inadequate intake (total nutrient intake <Estimated Average Requirement or Adequate Intake) for folate, vitamin B-6, niacin, calcium, copper, and phosphorus, due to lower intakes of these nutrients from foods. Cancer survivors also had a higher proportion of individuals with excess intake (total nutrient intake ≥Tolerable Upper Intake Level) for vitamin D, vitamin B-6, niacin, calcium, magnesium, and zinc, contributed by higher intakes of these nutrients from dietary supplements. Nearly half (46.1%) used dietary supplements on their own without consulting health care providers.ConclusionsCancer survivors reported a higher prevalence and dose of dietary supplement use but lower amounts of nutrient intake from foods than individuals without cancer. The inadequate nutrient intake from foods and the short-term and long-term health impact of dietary supplement use, especially at high doses, need to be further evaluated among cancer survivors.

Project description:ObjectiveTo estimate the prevalence of use and the micronutrient contribution of dietary supplements among pregnant, lactating, and nonpregnant and nonlactating women in the United States.MethodsCross-sectional data from 1,314 pregnant, 297 lactating, and 8,096 nonpregnant and nonlactating women (aged 20-44 years) in the 1999-2014 National Health and Nutrition Examination Survey were combined to produce statistically reliable, nationally representative estimates. Information about dietary supplements used in the past 30 days was collected through an interviewer-administered questionnaire and in-home inventory. The prevalence of nutrient-specific supplement use, mean daily nutrient intakes from supplements among users, and motivations for supplement use were assessed. Differences by age, income, and trimester within pregnant women were also tested.ResultsSeventy-seven percent of pregnant women and 70% of lactating women used one or more dietary supplements, whereas 45% of nonpregnant and nonlactating women used supplements. In particular, 64% of pregnant and 54% of lactating women used prenatal supplements. Mean intakes of thiamin, riboflavin, niacin, folic acid, vitamins B6, B12, and C, iron, and zinc from supplements alone were at or above their respective recommended dietary allowances (RDAs) among pregnant and lactating supplement users. About half of pregnant and 40% of lactating women took supplements based on the recommendation of a health care provider. Among pregnant women, those in their first trimester, aged 20-34 years, or in a lower-income family were less likely to use supplements compared with their counterparts.ConclusionThe majority of pregnant and lactating women used dietary supplements, which contributed many nutrients in doses above the RDAs. Although inadequate Intakes of folate and iron are of concern among pregnant women who are not using supplements, supplement users often consumed high doses, suggesting a potential need of health care providers to discuss dietary supplement use and the recommended doses of nutrients during pregnancy and lactation.

Dataset Information

Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States.

Publications

Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States.

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