Kobayashi Pharmaceutical’s growing scandal over its red yeast supplements has reignited debate on Japan’s “functional food” labels, which have been criticized for years over the lack of sufficient scientific proof of safety and efficacy accompanying their use.

The Osaka-based drugmaker on Friday confirmed another death associated with its line of beni kōji red yeast rice dietary supplements, bringing the reported fatality count to five, and the number of hospitalizations to 114. While the company has yet to pinpoint the cause of the health problems, it has said its beni kōji products may have unintentionally contained a yet-to-be-identified toxic substance.

Kobayashi Pharmaceutical is among many firms that utilize the kinōsei hyōji shokuhin label, or Foods with Function Claims (FFC). This functional food label was introduced in 2015, giving manufacturers a third way to advertise the health-enhancing ingredients in their products separately from two other health food labels.