# The Fall of Oral Phenylephrine: FDA Acts Against a Widely Used Cold Remedy
In a pivotal decision, the U.S. Food and Drug Administration (FDA) has begun the process of eliminating oral phenylephrine from over-the-counter (OTC) cold and allergy treatments. This action comes in response to years of accumulating evidence indicating that the medication, often utilized as a decongestant, fails to alleviate nasal congestion. Last year, FDA advisors unanimously determined that oral phenylephrine is ineffective, and the agency is now working to formally withdraw it from the market.
## What is Phenylephrine?
Phenylephrine serves as a decongestant by narrowing blood vessels in the nasal passages, theoretically reducing swelling and clearing airways. Since its FDA approval in 1976, it has been a key component in many well-known OTC cold and allergy formulations, such as Sudafed PE. However, it gained prominence post-2006 when the “Combat Methamphetamine Epidemic Act of 2005” restricted pseudoephedrine—another decongestant—behind pharmacy counters due to its association with illegal methamphetamine production. Consequently, phenylephrine became the preferred ingredient in many readily available decongestants.
## The FDA’s Decision
On Thursday, the FDA proposed an order to eliminate oral phenylephrine from the OTC monograph, signifying that manufacturers would no longer be allowed to include it in products aimed at providing temporary relief from nasal congestion. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, emphasized the agency’s obligation to ensure that medications are both safe and effective. “Based on our evaluation of the available data and consistent with the advisory committee’s recommendations, we are proceeding with this next step to propose the removal of oral phenylephrine, as it is ineffective as a nasal decongestant,” she remarked.
### A Long Time Coming
The FDA’s decision is the result of years of investigation and reassessment. Although phenylephrine received initial approval in the 1970s, its effectiveness has been questioned for many years. An FDA panel reassessed the drug in 2007, and while they maintained its approval, they called for further research. This led to three substantial, well-structured studies—two conducted by Merck for seasonal allergies and one by Johnson & Johnson for the common cold. All three studies revealed no significant difference between phenylephrine and a placebo.
Last year, the FDA closely examined the original 14 studies from the 1950s to the 1970s that had granted phenylephrine its initial approval. The agency discovered that these studies employed outdated and unreliable methods for assessing nasal congestion, and even then, their results were inconsistent. The overall efficacy conclusion relied on just two studies, both conducted in the same laboratory, and no other research facility has successfully replicated those findings. Upon further scrutiny, FDA scientists noted that some data from these studies appeared to be “too good to be true.”
### The Science Behind the Failure
One primary reason for the ineffectiveness of oral phenylephrine is its rapid metabolism in the gastrointestinal tract. When taken orally, fewer than 1 percent of the drug remains active in the body, indicating it does not enter the bloodstream in adequate amounts to constrict blood vessels and alleviate nasal congestion. This also accounts for why the drug does not produce the side effects, such as elevated blood pressure, occasionally seen with pseudoephedrine. Initially, this absence of side effects was regarded as a benefit, but looking back, it was a clear indicator that the drug was not functional.
### Industry Pushback
In spite of the substantial evidence against phenylephrine, the Consumer Healthcare Products Association (CHPA), representing manufacturers of phenylephrine-containing products, has voiced dissatisfaction with the FDA’s ruling. CHPA CEO Scott Melville released a statement declaring, “As scientific methods evolve, new data should be assessed in the context of the entire body of available evidence, rather than replacing the previous evidence entirely—especially for an ingredient as safely and widely used as PE.” The CHPA intends to review the FDA’s proposed order and provide feedback during the public comment phase.
### What Happens Next?
The FDA’s proposed order has yet to be finalized. The agency will initiate a public comment phase, allowing stakeholders to share their views. If no strong evidence contradicts the FDA’s findings, the order will become final, and manufacturers will be granted a grace period to reformulate their products without phenylephrine.
Some retailers, including CVS, have already begun the process of pulling products containing phenylephrine as the sole active ingredient from their inventory. However, the industry’s resistance indicates that the discussion surrounding phenylephrine may continue.
### Conclusion
The FDA’s initiative to eliminate oral phenylephrine from the market
