NCCIH Natural Products Policy Provides Guidance to Researchers for 15 Years
July 22, 2020
NCCIH’s mission includes research on a wide range of natural products, from vitamins and minerals to other single-constituent supplements (such as resveratrol, melatonin, and glucosamine), complex plant extracts, and probiotics. If you haven’t applied for a grant from us in this topic area, you may not know about the steps NCCIH takes to make sure the research we fund on natural products adheres to high standards for rigor and reproducibility. This effort is manifested in our Product Integrity Policy. I’ll introduce you to the Policy and offer some comments as we mark the 15-year point from its launch.
The primary goal of the Product Integrity Policy is to support confidence that natural products in NCCIH-funded studies are well characterized (i.e., their composition defined) such that the Center, the investigator, and peer reviewers can know the results will be properly interpreted and, if necessary, reproducible. Examples of information we require include product name and appropriate data to establish identity and purity; justification or rationale for use, including use of the supplier, chosen form, source parts, and mode of administration; and, for clinical studies, some other information such as known safety issues, pharmacokinetics, pharmacodynamics, biological or chemical markers of activity, applicable regulations, and the recommendations of expert bodies.
NCCIH first announced the Product Integrity Policy in 2005 and applied it to our grants starting in Fiscal Year 2006. For the first few years of the Policy, the information submitted by grantees was evaluated by a working group of experts from outside NCCIH. I came to the Center in 2009 with a background in industry R&D of pharmaceutical agents from natural sources and have been the Policy’s lead and the primary evaluator since then.
The Policy has been crafted to be applicable to all types of natural products, studies, and investigators. It evolves to meet changing needs. I have mentioned the wide range of products the Center studies; we also fund the entire spectrum of research, from very basic science to late-stage clinical trials assessing efficacy. Further, our applicants and investigators have varying backgrounds, with some well versed in the analysis of natural products and some not. NCCIH is glad to work closely with any applicant to help him or her navigate the process.
Since we have had the Product Integrity Policy in place, NCCIH has evaluated nearly 400 separate natural products. We have had countless opportunities to teach and to learn along the way. NCCIH remains committed to its core principle: to hold the Center to, and help others achieve, the highest standards of research integrity. In so doing, we hope to lead by example and encourage others engaged in natural products research to apply the same principles to their experiments. This will result in higher quality data, and increased confidence that decisions for or against use of a particular product are based on solid science.