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WASHINGTON —The Consumer Healthcare Products Association expressed strong disappointment in response to the U.S. Food and Drug Administration’s recent proposal to reevaluate the status of over-the-counter (OTC) oral phenylephrine (PE), a widely used decongestant. The proposed order challenges FDA’s longstanding recognition of PE as a safe and effective treatment for nasal congestion.
“CHPA is disappointed in FDA’s proposal to reverse its long-established view of oral PE,” said CHPA President and CEO Scott Melville in a statement. “For decades, people have relied on oral PE to relieve their nasal congestion. We believe Americans deserve access to safe and effective OTC medicines and the option to choose the products they prefer for self-care.”
Melville said the FDA’s proposal contradicts past decisions and recommendations, and said PE has consistently met the "generally recognized as safe and effective" (GRASE) standard for OTC ingredients. “OTC manufacturers have responsibly adhered to FDA’s acceptance of oral PE as ‘generally recognized as safe and effective,’” he stated, noting that FDA’s prior determinations were based on extensive reviews, including double-blind placebo-controlled trials, two advisory panels, and a meta-analysis of clinical studies.
As the only oral OTC decongestant available without restrictions, PE is a key ingredient in many cough and cold products. CHPA argues that limiting access to PE would reduce consumer choice in self-care, which is a critical component of the U.S. healthcare system. "Consumers need options for self-care," Melville stated. "Freedom of choice for self-care is a core attribute of our nation’s healthcare system.”
CHPA said it plans to review the proposed order and submit comments, urging FDA to consider the full body of evidence rather than dismissing prior research on PE’s efficacy.
