FDA Proposes New Policy to Target Certain Homeopathic Drugs | NCCIH

FDA Proposes New Policy to Target Certain Homeopathic Drugs | NCCIH

Clinical Digest: Complementary Health Approaches for Seasonal Affective Disorder Some people turn to complementary health approaches to prevent SAD, including St. John’s wort, melatonin, and vitamin D. This issue of the digest provides the summary of current research for these modalities.

In the News: FDA Proposes New Policy to Target Certain Homeopathic Drugs  On December 18, 2017 the U.S. Food and Drug Administration (FDA) released a new proposed policy targeting unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients. According to the FDA’s Web site, the new approach aims to protect consumers who choose to use homeopathic products, by updating the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. The new policy also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

Have a Research Question that the NIH All of Us Program Could Address?

 The NIH All of Us Research Program invites you to submit your ideas of important research questions the program could answer. Are there important questions that this cohort could address in areas of pain, mind-body, and natural products? The input will help the program identify new features to add to the All of Us platform to support research across a range of health topics and advance precision medicine. The deadline for input is February 9, 2018. 

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Resources for Researchers

Discovery and Biological Signatures of Diet-Derived Microbial Metabolites (R01 Clinical Trial Optional) Application Due Date: March 19, 2018 by 5:00 PM local time of applicant organization. Purpose: The purpose of this FOA is to solicit applications to identify metabolites produced by the interaction between commensal bacteria and dietary phytochemicals and characterize their biological activity.  This FOA will support both model systems research, and mechanistic clinical studies. As you may know, evidence is building that low molecular weight compounds, derived from interaction of dietary constituents and other natural products with the gut microbiome, have important biological activity. And, there is an established and growing evidence base to support the hypothesis that the gut microflora can metabolize dietary compounds into metabolites with important biological activity. Frequently, these compounds are phenolic acids, which may be derived from a wide range of precursors. These small, gut-derived metabolites may ultimately be the missing link that explains the widely acknowledged health benefits of diets high in fruits and vegetables. A handful of investigators are conducting research in this area, and they have provided a proof of concept to support the hypothesized interaction between the microbiome, dietary phytochemicals, and improved health outcomes. A concerted effort is now needed to systematically identify the variety of microbial metabolites produced, the commensal bacteria responsible for their production, and their potentially beneficial biological activities.  This FOA is intended to: Encourage applications that will provide much needed data to fill current gaps in our understanding regarding the abundance and variety of these gut-derived metabolites and how they individually and/or collectively might have biological signatures associated with improved measures of health and resilience.  Allow human mechanistic studies (which can be a type of clinical trial), but they must be designed to measure mechanistic endpoints (e.g., establishing a biological signature) rather than assess efficacy in modulating any clinical outcome. Specific disease models or populations may be included as long as the focus is on identifying, assessing, or modulating specific mechanistic measures rather than on direct disease/condition modulation.