Although the FDA has determined that the ingredient is safe for use, many doctors have raised concerns about the effectiveness of phenylephrine for several years.
While the FDA has concluded that the ingredient is safe for use, numerous doctors have expressed reservations about the effectiveness of phenylephrine for several years.
CVS has already made the decision to remove products containing phenylephrine as the sole active ingredient from their stores. In a statement provided to CNN on Thursday, a CVS spokesperson confirmed this action, stating, “We are removing certain oral cough and cold products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores.” The company, however, will continue to offer other “oral cough and cold products” to meet consumer needs.
In their statement, CVS also mentioned their awareness of the FDA Advisory Committee’s stance on oral phenylephrine (PE) and their commitment to following the FDA’s guidance to ensure their products adhere to all applicable laws and regulations.
It’s worth noting that Walgreens has not taken a definitive stance on this issue and is awaiting the final decision from federal regulators before making any changes. CNN has attempted to reach out to other retail pharmacies to determine if they plan to take similar actions.
While the FDA has affirmed the safety of phenylephrine, there have been ongoing concerns about its effectiveness among many medical professionals. These products, which utilize phenylephrine as the active ingredient, generated nearly $1.8 billion in sales in the previous year, according to data presented to the Nonprescription Drugs Advisory Committee during their two-day meeting in September.
In the recent past, the advisory committee voted negatively on the specific question: “Do the current scientific data that were presented support that the monograph dosage of orally administered phenylephrine is effective as a nasal decongestant.”
The FDA has informed the committee that it will consider their advice but hasn’t provided a specific timeline. Furthermore, the agency has not issued a final decision on the status of phenylephrine and has not instructed manufacturers or retail pharmacies to remove products containing this ingredient from their shelves. FDA has determined
The Consumer Healthcare Products Association (CHPA), which represents manufacturers of over-the-counter medicines, dietary supplements, and consumer medical devices, and opposes regulatory changes, expressed disappointment with the committee’s decision. They encouraged the FDA to consider the overall body of evidence supporting the use of oral phenylephrine and to take into account potential adverse consequences associated with any changes to its regulatory status.
A spokesperson for CHPA, Logan Ramsey Tucker, emphasized, “Until FDA makes a determination on the committee’s recommendation, oral PE remains a Category 1 OTC ingredient, which is generally recognized as safe and effective (GRASE).”