By John Q. Hosedrinker 
The Food and Drug Administration has proposed removing oral phenylephrine, a common ingredient in over-the-counter cough and cold medicines, from the market due to its ineffectiveness as a nasal decongestant. This decision follows the agency’s own scientific review, which found that oral phenylephrine is poorly absorbed into the bloodstream and its effectiveness is questionable, contradicting earlier studies. The FDA is seeking public comment on this proposal, and if finalized, manufacturers will need to remove or reformulate products containing oral phenylephrine. While the FDA considers oral phenylephrine safe at current levels, it acknowledges that higher doses would be needed to achieve any meaningful effect, raising safety concerns.
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The FDA is proposing to pull phenylephrine, a common decongestant found in many over-the-counter cold medications, from the market. This decision comes after years of evidence demonstrating its ineffectiveness as a nasal decongestant. The agency’s proposed order would remove oral phenylephrine from the list of ingredients that drugmakers are allowed to use in cough and cold medicines sold without a prescription.
For years, people have expressed their frustration with the perceived ineffectiveness of phenylephrine. Many have pointed out that it’s essentially a placebo and that the real decongestant, pseudoephedrine, can be obtained over the counter with some restrictions, such as showing identification and being added to a monitoring list.
The move to restrict access to pseudoephedrine was implemented due to its use in the illicit production of methamphetamine. This led to the widespread adoption of phenylephrine as a substitute ingredient in over-the-counter medications. However, studies have consistently shown that phenylephrine lacks the effectiveness of pseudoephedrine in treating nasal congestion.
This proposed action by the FDA has received widespread support from those who have long recognized the ineffectiveness of phenylephrine. Many people have expressed relief that the FDA is finally taking action to remove this ineffective ingredient from the market. They argue that it’s unfair to continue selling a product that provides no real benefit to consumers.
Some have pointed out the irony of the situation, noting that the government’s attempt to limit access to pseudoephedrine due to its use in methamphetamine production ultimately led to the widespread use of an ineffective alternative. The removal of phenylephrine could be seen as a step towards restoring access to a truly effective decongestant for those who need it.
However, there have been some dissenting voices. A few individuals have argued that phenylephrine can be effective for certain individuals, though the scientific evidence overwhelmingly contradicts this claim. Others have expressed concern about the potential impact of the decision on the availability of effective cold medications, even though there are other decongestant options available, like pseudoephedrine, that have proven effectiveness.
Despite these dissenting voices, the FDA’s proposed action has been widely applauded by those who advocate for consumer protection and evidence-based healthcare. The removal of phenylephrine from the market would represent a significant step towards ensuring that consumers have access to effective medications and are not misled by the marketing of ineffective treatments. It is important to remember that the public has until May of next year to submit their comments on the proposed order, ensuring that a variety of perspectives are considered before the FDA makes its final decision.