FDA Mandates Major Labeling Changes on Opioid Pain Medication

The stricter labeling requirement restores transparency and accountability ‘to a system that betrayed the American people,’ the health secretary said.

Opioid pain medications sit on a table outside of Los Angeles, on June 4, 2025. John Fredricks/The Epoch Times

The Food and Drug Administration is requiring pharma companies selling opioid pain medications to “better emphasize and explain the risks associated with their long-term use” on medication labels, the Department of Health and Human Services (HHS) said in a July 31 statement.

“These changes follow a public advisory committee meeting in May that reviewed data showing serious risks—such as misuse, addiction, and both fatal and non-fatal overdoses—for patients who use opioids over long periods,” the department said.