Division of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA; ICF International, Inc., Durham, NC, USA.
Office of Dietary Supplements, National Institutes of Health, Bethesda, MD, USA.
Food Chem Toxicol. 2018 Aug;118:963-971. doi: 10.1016/j.fct.2018.04.007. Epub 2018 Apr 4.
Due to the extensive use of botanical dietary supplements by consumers in the United States, there is a need for appropriate research and data to support safety assessments. Complexity and variability, both natural and introduced, of botanical dietary supplements make research on these products difficult. Botanical dietary supplements are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 1994 Dietary Supplement Health and Education Act (DSHEA). They are regulated as a category of food, which differs from the regulation of pharmaceutical products. Both manufacturers and the FDA are faced with the challenge of determining the best approaches for evaluating and monitoring the safety of botanical products. High quality botanicals research requires accurate identification and characterization of the material being studied. Inconsistent results in efficacy studies of botanical dietary supplements have led to efforts to improve the rigor and reproducibility of research in the field. Addressing the challenges associated with botanical dietary supplement safety is a global effort requiring coordination between numerous stakeholders, including researchers, suppliers, manufacturers, and regulators, all of whom play a role in ensuring that high quality products are available on the market.
由于美国消费者广泛使用植物性膳食补充剂，因此需要进行适当的研究和数据支持安全性评估。植物性膳食补充剂的复杂性和可变性，无论是天然的还是引入的，都使得对这些产品的研究变得困难。植物性膳食补充剂受美国食品和药物管理局（FDA）根据 1994 年《膳食补充剂健康与教育法案》（DSHEA）修订的《联邦食品、药品和化妆品法案》（FD&C 法案）监管。它们被归为食品类别进行监管，与药品的监管方式不同。制造商和 FDA 都面临着确定评估和监测植物产品安全性的最佳方法的挑战。高质量的植物研究需要准确识别和描述正在研究的材料。植物性膳食补充剂功效研究中的不一致结果导致人们努力提高该领域研究的严谨性和可重复性。解决与植物性膳食补充剂安全性相关的挑战是一项全球性努力，需要众多利益相关者之间的协调，包括研究人员、供应商、制造商和监管机构，他们都在确保市场上提供高质量的产品方面发挥作用。
