Oral Phenylephrine Is an Effective Treatment for Nasal Congestion

CHPA disputes question of effectiveness raised in medical journal

Washington, D.C. (August 24, 2006)—The Consumer Healthcare Products Association issued the following statement in response to a letter to the editor published in the July 2006 Journal of Allergy and Clinical Immunology:

"American consumers have been using phenylephrine to treat nasal congestion for decades. In 1976, FDA issued the report of an advisory committee of outside experts where the committee completed an extensive review of phenylephrine and concluded that it is safe and effective for over-the-counter use. FDA’s own extensive review agreed with that conclusion. In fact, just this month, FDA approved a new formulation type of phenylephrine.

"The recent ’Letter to the Editor‘ published in the July 2006 Journal of Allergy and Clinical Immunology bases its findings on the same data that was available before the advisory committee recommended phenylephrine be found safe and effective for over-the-counter use and no new data has been presented that disputes FDA’s conclusion.

"In an effort to provide Americans with choice and access to their favorite cold medicines, many CHPA member companies reformulated their over-the-counter pseudoephedrine containing medicines with phenylephrine. In fact, Congress specifically asked the FDA to expedite review of new or supplemental drug applications which seek approval to reformulate from pseudoephedrine. Most of such applications would include phenylephrine as the new active ingredient. Congress took these steps to ensure consumers continue to have a widely available safe and effective nasal decongestant. "

Contacts: Elizabeth Assey and Virginia Cox, 202.429.9260

CHPA is the 125-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplement products.