Following an FDA advisory committee's determination that a common ingredient in over-the-counter cough and cold medicines is ineffective, the agency released a statement clarifying it has not yet made a final decision on the matter.
An advisory committee agreed Sept. 12 that oral phenylephrine, a common ingredient in OTC cold medicines, does not relieve congestion. The FDA has been evaluating data on the efficacy of oral formulations of the ingredient since 2007. Over the years, data has shown it does not help relieve symptoms, and FDA advisors met to consider the matter Sept. 11-12, when they concluded it is not effective as a nasal decongestant.
Days later, the FDA clarified it has not yet made a decision.
"Advisory committees provide independent advice and recommendations to FDA, but the agency makes the final decision. FDA will consider the input of this advisory committee, and the evidence before taking any action on the status of oral phenylephrine," the agency said Sept. 14.
If the FDA does determine oral phenylephrine is not effective, it would propose an order to revoke its current classification as "generally recognized as safe and effective." The public would then be invited to comment on the matter and the FDA would issue a final order after considering public comments.
"FDA would then work closely with manufacturers to reformulate products as needed to help ensure the availability of safe and effective products to treat symptoms of colds or allergies," the agency said.