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是时候进行一次大变革了——美国化妆品监管制度。

Time for a makeover-cosmetics regulation in the United States.

机构信息

Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

Department of Ophthalmology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

出版信息

J Cosmet Dermatol. 2019 Dec;18(6):2041-2047. doi: 10.1111/jocd.12886. Epub 2019 Apr 4.

Abstract

INTRODUCTION

Cosmetics and personal care products are ubiquitous. Consumer pressure arising from recent episodes of products found to be unsafe has led to new policy proposals to modernize cosmetics regulation in the United States.

METHODS

We reviewed contemporary cosmetics regulation and collected major past and current policy proposals relating to cosmetics regulation with a focus on public health controversies.

RESULTS

Under a structure originally established in 1938 that places regulation of cosmetics under the Food and Drug Administration (FDA), cosmetics manufacturers in the United States are not required to register their products or forward consumer complaints to the FDA, leading to broad under-reporting of adverse events. The FDA has limited authority to mandate product recalls. The existing FDA database system that collects adverse events related to cosmetics has limited public health utility. Current proposals for new cosmetics regulations seek to establish better systems for data collection and mandatory manufacturer registrations funded by cosmetic manufacturers. Additional policy changes could include a premarket review process for cosmeceuticals (cosmetics that make drug-like claims) and more advanced real-world data safety monitoring tools.

CONCLUSIONS

With continued consumer concern and several recent cosmetic-related public health controversies, the FDA should be given more resources and broader authority to protect consumer safety.

摘要

简介

化妆品和个人护理产品无处不在。最近发现一些产品不安全的事件引发了消费者的压力,这导致了新的政策提案,旨在使美国的化妆品监管现代化。

方法

我们回顾了当代化妆品监管,并收集了与化妆品监管相关的主要过去和当前政策提案,重点关注公共卫生争议。

结果

在美国,根据最初于 1938 年建立的结构,将化妆品的监管置于食品和药物管理局(FDA)之下,化妆品制造商无需注册其产品或向 FDA 转发消费者投诉,导致不良事件广泛漏报。FDA 召回产品的权力有限。现有的 FDA 数据库系统收集与化妆品相关的不良事件,但对公共卫生的实用性有限。新的化妆品法规的现行提案旨在建立更好的系统,以收集数据和强制性制造商注册,由化妆品制造商提供资金。其他政策变化可能包括对具有药物宣称的化妆品(即宣称具有药物功效的化妆品)进行上市前审查程序,以及更先进的真实世界数据安全监测工具。

结论

随着消费者持续关注以及最近发生的几起与化妆品相关的公共卫生争议,应向 FDA 提供更多资源和更广泛的权力,以保护消费者安全。

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