FDA, Health Canada Address Supplement Safety

LAS VEGASSupplySide West attendees heard representatives from the U.S. Food and Drug Administration (FDA) and Health Canada speak about botanical dietary supplement safety during the Education Program Oct. 20. The session attracted more than 200 industry members.

Robin Marles, Ph.D., director of the Bureau of Clinical Trials and Health Sciences, Natural Health Products Directorate at Health Canada gave an overview of Canadian supplement regulations followed by an assessment of how safety can be evaluated for supplements. He described extrinsic risks such as botanical misidentification, contamination, incorrect strength, etc. He also addressed standards of evidence such as clinical trials and historical use, stating that for safety, science trumps tradition."

Marles also emphasized the importance of quality processes and gave an overview of specific industry efforts that play a role in safety, such as the SIDI protocol and efforts by U.S. Pharmacopoeia. Without quality, you have no assurance of safety," he said.

Following Marles' presentation, attendees heard from Bradford Williams, manager of the Division of Dietary Supplement Programs at FDA, who discussed the role GMPs (good manufacturing practices) play in safety. He said as of Sept. 10, the FDA had completed 99 GMP inspections with about 33 percent failing for serious reasons. Some of the common serious problems included a lack of identity testing, a lack of specifications, and no adequate corrective action plans.

Williams spent a good deal of time discussing supplier qualification, including minimum FDA criteria for supplier qualification and the use of third parties for the task. He also emphasized that without full GMP compliance, safety cannot be established. He also got a chuckle from the audience when he displayed a slide showing dozens of GMP certified" seals and symbols that have shown up in the marketplace.