The U.S. Food and Drug Administration (FDA) announced on Nov. 7 a plan to boot oral phenylephrine, a staple in many over-the-counter (OTC) cold medications, off the shelves. After pouring over the data, the FDA’s decision is clear: oral phenylephrine doesn’t actually help with nasal congestion. Yes, folks, the “relief” you’ve been reaching for in countless cold meds is apparently all just smoke and mirrors. It’s been in products like Sudafed PE, DayQuil, Tylenol Sinus Congestion & Pain, and Robitussin Peak Cold Nasal Relief for years, and now the FDA says it’s time for a change.
Patrizia Cavazzoni, M.D., head of the FDA’s Center for Drug Evaluation and Research, said, “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.” So, until they officially pull the trigger, manufacturers can still sell the stuff, but it’s just a matter of time.
Here’s what’s amusing: phenylephrine became the “legal” choice in cold meds because the feds, in their infinite wisdom, restricted pseudoephedrine back in 2005. Why? Because pseudoephedrine, unlike phenylephrine, actually worked but also had potential for misuse in meth production. So, for nearly two decades, Big Pharma has been cashing in on a product that, if the FDA’s findings hold up, hasn’t done much more than empty wallets while failing to clear sinuses.
Consumers can rest easy, though. Other options are out there, like pseudoephedrine, which, though locked behind the pharmacy counter, still provides real relief. Alternative treatments include nasal sprays, saline rinses, and humidifiers — options that actually help. Theresa Michele, M.D., the FDA’s director of nonprescription drugs, noted that “Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold.” In other words, the “phenylephrine placebo” era may soon be over.
In a world where Democrats seem to love telling us what’s best, it’s about time a little transparency made its way into something as straightforward as cold medicine. While the left remains enamored with Big Pharma’s big promises, the FDA’s move signals that maybe — just maybe — people deserve remedies that actually work. And who knows, maybe some free-market innovation will finally bring us cold meds without the junk. Here’s to a healthier America, where empty promises aren’t welcome in the medicine aisle or the voting booth.
