CHPA Responds to FDA Proposed Order Regarding the Status of OTC Phenylephrine:

(WASHINGTON, D.C.) - The Consumer Healthcare Products Association's (CHPA) President and CEO Scott Melville released the following statement today in response to FDA's Proposed Order regarding the status of over-the-counter (OTC) phenylephrine (PE):

"CHPA is disappointed in FDA's proposal to reverse its long-established view of oral PE. 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.

"This proposed change is at odds with previous FDA decisions and Advisory Committee recommendations. OTC manufacturers have responsibly adhered to FDA's acceptance of oral PE as "generally recognized as safe and effective" (GRASE), the scientific and regulatory standard for OTC ingredients. FDA's long-held determination was based on a thorough review of multiple double-blind placebo-controlled trials, supported by two previous FDA advisory panels, and validated by a meta-analysis of relevant clinical studies. CHPA maintains its position that no changes to the GRASE status of oral PE for nasal decongestion are warranted based on data made available since the previous review in 2007. As science and methods advance, new data should be considered in the context of the full weight of available evidence, not as a complete replacement of the previous body of evidence - especially when considering an ingredient as safely and widely used as PE. CHPA will review the Proposed Order and submit comments accordingly.

"PE is the only oral OTC decongestant available without purchase restrictions and is included in numerous OTC cough and cold medicines labeled with a decongestant claim. Consumers need options for self-care, and freedom of choice for self-care is a core attribute of our nation's healthcare system. PE should remain an available option for consumers, because Americans deserve the option to choose the safe and effective OTC medicines they prefer and rely on."