How can we improve the safe use of herbal medicine and other natural products? A clinical pharmacologist mission

ABSTRACT

Introduction

Three major classes of natural products (NPs) for medicinal purposes or improving wellbeing are generally available in the US: conventional drugs of herbal origin, botanical drugs, and dietary supplements (DSs). Consumer consumption of DSs is growing annually. The U.S. FDA regulates conventional and botanical drugs for safety and efficacy; however, DSs are minimally regulated.

Areas covered

This article will: i) highlight the importance of NP as a significant source of prescription drugs; ii) discuss differences in the regulation of conventional drugs of NP product, botanical drugs, and DSs; iii) discuss the safety and efficacy of DSs and iv) make recommendations for improvement of safety for minimally regulated NPs.

Expert opinion

Toxicities associated with the use of NPs, including vitamins and DSs, are mainly due to excessive use and interactions with conventional drug(s) and may represent challenges for clinicians. Conventional and botanical-based prescription drugs are rarely associated with unknown toxicities. However, DSs are minimally regulated and can produce severe adverse effects. We believe that clinical pharmacologists can have a role in developing criteria for DS safety analysis. There is also the potential for a standardized NP stewardship program(s) and the development of NP policies and practices nationally and globally.

KEYWORDS:

• Clinical pharmacology
• clinical toxicology
• FDA regulation
• herbal medicine
• natural products
• safety and efficacy

Article highlights

• Consumer interest and consumption of dietary supplements is growing.

• Dietary supplements are minimally regulated by the US FDA and may have serious safety concerns.

• Excessive use of dietary supplements could potentiate the toxicity of conventional drugs concurrently administered with dietary supplements.

• There is a need to develop criteria for dietary supplements safety analysis and establish natural product stewardship in major hospitals in the US and worldwide.

Author contributions

EYE, KMJ, LVK, MDR, CMS contributed to the conception, design, and preparation of the manuscript. EYE, LVK outlined the initial literature review and interpretation of published data. EYE, KMJ, LVK, MDR, CMS made substantial contributions in drafting the manuscript and revising it critically for valuable intellectual content. All authors have read and approved the final version of the manuscript.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants, or patents received or pending, or royalties.

Reviewer declaration

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.