FDA Slow to Ban Ineffective Over the Counter Oral Phenylephrine

November 8, 2024

FDA Slow to Ban Ineffective Over-the-Counter Oral Phenylephrine

WASHINGTON, D.C. - A proposed ruleby the Food and Drug Administration (FDA) finally initiates the process of removing ineffective, albeit safe, over-the-counter oral formulations of phenylephrine from the U.S. market. Oral phenylephrine is commonly sold in cough and cold medicines, either alone or in combination with other ingredients, for temporary nasal congestion relief.

In September 2023, an independent FDA Nonprescription Drugs Advisory Committee unanimously voted(16-0) that the current dosage of orally administered phenylephrine is not effective for nasal congestion relief. The committee's decision was based on consistent and compelling scientific evidence presented by FDA scientists that oral phenylephrine does not work.

Azza AbuDagga, Ph.D., Health Services Researcher at Public Citizen's Health Research Group, who urgedthe 2023 advisory committee to vote against the effectiveness of oral phenylephrine, said the FDA is moving too slowly.

"The fact that it took the FDA over a year to propose removing oral phenylephrine demonstrates how unacceptably tardy the agency is," said AbuDagga. "In September 2023, the agency had all the information it needed to conclude there are no data demonstrating that oral phenylephrine is effective as a nasal decongestant at any dosage. By dragging its feet in issuing the proposed rule and continuing to allow labeling of oral phenylephrine products to indicate that they are 'effective' for the 180-day public comment period and until a final rule is issued, the agency is failing the public."