In a groundbreaking announcement on Wednesday, the Food and Drug Administration (FDA) declared its intention to remove a popular ingredient from cough and cold medications—oral phenylephrine—after extensive research concluded that it is ineffective as a nasal decongestant.

This decision follows a significant advisory vote last year, where independent experts urged caution regarding the continued approval of phenylephrine. They raised eyebrows about the initial studies that underpinned its approval and highlighted recent evidence casting doubt on its efficacy.

For years, oral phenylephrine has been a key component in numerous over-the-counter (OTC) cold and cough remedies, including well-known names like Advil, NyQuil, Sudafed, Robitussin, Tylenol, and Theraflu. However, the FDA's review underscored that this common ingredient has not been providing the relief that consumers have been led to expect.

Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, stated, “Based on our review of available data, we are taking this next step to propose removing oral phenylephrine because it is not effective as a nasal decongestant.” The FDA is planning to eliminate this ingredient from the list of permissible substances in non-prescription cough and cold medications.

The public will have a chance to voice their opinions on this proposal until May 7 of next year. If the FDA moves forward with its decision, manufacturers will be given sufficient time to adjust their formulations or take affected products off the shelves.

In response to the FDA's announcement, the Consumer Healthcare Products Association expressed their disappointment, arguing that phenylephrine remains a viable option for consumers. They referenced previous FDA decisions that did not require the ingredient to be withdrawn and emphasized that Americans should have the freedom to choose their preferred OTC medications.

Moreover, CVS pharmacy stated it would start removing products containing only oral phenylephrine from its inventory following the advisory committee's earlier findings.

Pressure on the FDA has been building, particularly from pharmacy professors at the University of Florida, who have been advocating for this change for years. Their research revealed that the absorption of phenylephrine when taken orally is minuscule, contradicting earlier studies that suggested higher absorption rates. In fact, less than 1% of this medication enters the bloodstream when processed as a pill or syrup, unlike other formulations like nasal sprays, which allow for greater absorption.

The recent scientific review noted that the early studies were based on outdated technology, which led to inflated estimates of the drug's effectiveness. Researchers concluded that not only is oral phenylephrine safe at approved levels but that it simply does not deliver the intended results for nasal congestion relief.

Hatton, one of the Florida pharmacists involved, emphasized, “Oral phenylephrine is not a safety risk; it just doesn't work.” The findings call into question the clinical data supporting the ingredient's use, indicating that no effective dosages have been identified.

As this controversial proposal unfolds, consumers and manufacturers alike must prepare for the potential upheaval in the cold and cough medicine market. Will this FDA decision prompt a reevaluation of other longstanding medication ingredients? Only time will tell as the clock ticks down to the public comment deadline on May 7!