Collecting Information on Dietary Supplement Safety

Toxicologists, other scientists, and clinicians generally agree that dietary supplements are safe for consumption when used appropriately. However, all recognize that there is a paucity of toxicity information available on them, as most human toxicity data must come from post-market analysis and data collection.

As a result, during today’s session “Improving the Safety of Dietary Supplements and Natural Health Products by Assessing Effects in Humans” together academicians, researchers, regulators, clinical physicians and pharmacologists, and global corporate product safety experts to discuss how to better obtain and interpret human data regarding dietary supplement use.

Participants included:

  • Scott A. Jordan, DPhil, Health Canada, and co-chair of the session;
  • Lewis Nelson, MD, NYU Emergency Medicine Associates;
  • Rick Kingston, PharmD, University of Minnesota;
  • Bill Gurley, PhD, University of Arkansas for Medicinal Sciences;
  • Chris Xing, PhD, University of Minnesota; and
  • Vasilios Frankos, PhD, Herbalife.

Dr. Jordan began the session by introducing the idea of human data collection and use in assessing dietary supplement safety. He described how human data could be intentionally obtained from appropriately planned and executed randomized, controlled, clinical trials and other controlled studies.

Next, Dr. Nelson discussed the difficulty patients and clinicians have talking about dietary supplement use during visits and appointments. He conveyed how difficult it is to link adverse health effects to specific dietary supplements when there is a lack of adequate baseline material. Work is needed on both the patient and physician side to improve this communication.

The gaps in dietary supplement safety surveillance were the topic of Dr. Kingston’s presentation. He discussed how the US has had a mandatory adverse event reporting system in place since 2006, yet US FDA citations for violations continue to escalate. He described a need for supplemental post-market surveillance systems.

For two decades, Dr. Gurley and his team have been studying dietary supplements, and today, he presented some of the shortcomings associated with dietary supplement formations and how this can impact the clinical significance of a case report or adverse event report.

Dr. Xing used his time to speak about a particular supplement, known as kava, which was removed from the European market due to reports of rare hepatoxicity potentially linked to its usage. He presented some of the beneficial and adverse effects of kava uncovered by his team.

Wrapping up the session, Dr. Frankos focused on adverse event reports and how global collection of these reports would help dietary supplement companies monitor product safety and quality. He recommended integrating post-market adverse event reports with product quality complaints to ensure the most comprehensive investigative practices.

The session's other co-chair was James C. Griffiths, PhD, DABT, CBiol, FIBiol, Council for Responsible Nutrition.

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