Ms. Burgess confirmed that there have been a total of 92 patient reports, including 33 hospitalizations and 13 deaths. She added that the agency is carefully investigating and evaluating all possible causes of death before deciding whether the beverages actually caused the medical problems. “The existence of an adverse event report does not necessarily mean that the product identified in the report actually caused the adverse event,” she said. “FDA assesses the relationship, if any, between a product or ingredient and the reported adverse event. If we find a relationship between consumption of the product and harm, FDA will take appropriate action to reduce or eliminate the risk.”
She pledged that the FDA would continue to work with the complainants, medical professionals, state and local health authorities, and dietary supplement manufacturers and distributors, who are required by law to report any new medical information received within a year of the adverse event report.