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在线销售减肥补充剂:标签和营销是否符合美国食品和药物管理局对麻黄素的禁令。

Online Marketing of Weight Loss Supplements: Labeling and Marketing Compliance with the U.S. Food and Drug Administration Ban on Ephedra.

机构信息

Utilization Management at United Health Group, Irvine, CA, USA.

Medical Plaza Pharmacy, San Francisco, CA, USA.

出版信息

J Altern Complement Med. 2021 Sep;27(9):796-802. doi: 10.1089/acm.2021.0016. Epub 2021 May 12.

Abstract

To characterize dietary supplements marketed online as "ephedra-containing or ephedra-like products" for weight management and to assess labeling/marketing compliance with the ban on the sale of ephedrine alkaloids. This cross-sectional study assessed websites selling ephedra-like supplements using the search term "buy ephedra." For each website, the first three featured products were characterized by evaluating the label for (1) sp. or its alkaloid content, (2) serving size, (3) other ingredients, (4) directions, (5) side effects, (6) reported interactions, (7) recommendation to consult a health care provider, (8) recommendation to use with diet and exercise, and (9) Food and Drug Administration (FDA) disclaimer. Thirty-six (71%) of the first 51 websites evaluated sold at least one weight loss product. A total of 105 products were assessed, 93 had labeling with 10 (11%) in possible violation of the ephedra ban. Five were labeled as containing ephedrine or ephedrine hydrochloride, two reported containing ephedrine alkaloids, and two reported containing unidentified sp. not formulated as an extract; one reported containing . Sixty-seven (72%) products listed caffeine with a daily serving size averaging 400 mg. Other ingredients with stimulant properties include green tea, yohimbe, and phenylethylamine. Nearly 20% of websites sold weight loss products that potentially violated the 2004 ban of ephedra alkaloids. Ephedrine, unidentified sp. not formulated as an extract, and were labeled as present in 11% of products evaluated. Incomplete reporting of adverse effects and drug interactions was common.

摘要

本研究旨在描述作为体重管理产品在网上销售的、被标注为“含麻黄或麻黄样产品”的膳食补充剂,并评估这些产品在销售含有麻黄碱类物质的禁令方面是否符合标签/营销规范。本横断面研究通过使用“购买麻黄”这一搜索词评估了销售麻黄样补充剂的网站。对于每个网站,通过评估标签来对前三种特色产品进行以下特征描述:(1)具体成分或其生物碱含量;(2)服用剂量;(3)其他成分;(4)使用说明;(5)副作用;(6)报告的相互作用;(7)建议咨询医疗保健提供者;(8)建议与饮食和运动相结合;(9)食品和药物管理局(FDA)免责声明。在评估的前 51 个网站中,有 36 个(71%)网站至少销售一种减肥产品。共评估了 105 种产品,其中 10 种(11%)可能违反了麻黄禁令,10 种产品标签存在问题。有 5 种被标记为含有麻黄素或盐酸麻黄碱,2 种报告含有麻黄碱生物碱,2 种报告含有未被制成提取物的未鉴定的具体成分;1 种报告含有 。67%(72%)的产品列出了咖啡因,每日服用量平均为 400mg。其他具有刺激特性的成分包括绿茶、育亨宾和苯丙胺。近 20%的网站销售可能违反 2004 年麻黄碱类物质禁令的减肥产品。在评估的产品中,有 11%的产品标签上含有麻黄素、未被制成提取物的未鉴定具体成分和 。常见的情况是,对不良反应和药物相互作用的报告不完整。

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