Statement from the Consumer Healthcare Products Association on Today’s FDA Advisory Committee Meeting on the Efficacy of Phenylephrine in the 10 mg Oral Dose

Washington, D.C. (December 14, 2007)—Following is a statement by Linda A. Suydam, D.P.A., president of the Consumer Healthcare Products Association (CHPA), regarding the recommendations of the U.S. Food and Drug Administration’s Nonprescription Drugs Advisory Committee on phenylephrine:

"Phenylephrine 10 mg is safe when used according to the label and has been proven effective for nasal decongestion in multiple clinical trials. Today, the FDA’s expert panel voted almost unanimously [11-1] that the existing evidence supports the effectiveness of phenylephrine at the 10 mg dose and reaffirms the results of numerous scientific studies and decades of consumer experience.

"CHPA and the leading makers of OTC cough, cold, and allergy medicines containing phenylephrine are committed to adding to the existing body of evidence currently supporting the safety and efficacy of phenylephrine. Our goal is to continue to provide consumers with safe and effective therapies, and we are committed to working with FDA to ensure that the scientific data further supports this goal.

"Consumers should remain confident that phenylephrine 10mg provides safe and effective relief from nasal congestion due to the common cold and allergies and that this FDA-approved nasal decongestant will remain conveniently available over-the-counter.

"For over forty years, consumers worldwide have relied upon phenylephrine to give them much needed relief from nasal congestion caused by the common cold and allergies. We look forward to working with FDA staff as they review the recommendations of today’s panel. We will continue our commitment to ensure that consumers have access to safe and effective over-the-counter therapies."

Contacts: Elizabeth Funderburk and Virginia Cox, 202.429.9260


CHPA is the 126-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.