Kapoor Akshay, Sharfstein Joshua M
Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA.
Drug Test Anal. 2016 Mar-Apr;8(3-4):424-30. doi: 10.1002/dta.1892. Epub 2015 Nov 2.
Despite increasing use of dietary supplements by millions of consumers, regulation of these products has not kept pace with changes and risks in the market. A major reason for this policy gridlock is the inability of different parties to come to an agreement on a path forward. The purpose of this paper is to set out a new framework for regulation in which consumers, industry, and regulators can all find common ground. This framework is based on a conceptual shift from 'benefit versus risk', the model for prescription drugs, to 'access with safety'. Steps should include registration of all dietary supplements to permit easier enforcement against rogue products, a stronger disclaimer explaining the limited role of FDA in evaluating structure/function product claims, the establishment of standard laboratory techniques for characterization of products, and more clear authority for the agency when safety concerns arise. Copyright © 2015 John Wiley & Sons, Ltd.
尽管数以百万计的消费者越来越多地使用膳食补充剂，但对这些产品的监管却未能跟上市场变化和风险的步伐。造成这种政策僵局的一个主要原因是不同各方无法就前进的道路达成一致。本文的目的是提出一个新的监管框架，使消费者、行业和监管机构都能找到共同点。这个框架基于一种概念转变，即从处方药的“效益与风险”模式转变为“安全获取”模式。措施应包括对所有膳食补充剂进行注册，以便更容易打击违规产品；提供更强有力的免责声明，解释美国食品药品监督管理局（FDA）在评估产品结构/功能声明方面的有限作用；建立产品特性描述的标准实验室技术；以及在出现安全问题时赋予该机构更明确的权力。版权所有© 2015约翰·威利父子有限公司。
