As the cold and cough season approaches, the FDA is proposing a significant change to over-the-counter cold medications by recommending the removal of phenylephrine, a common ingredient found in popular products like NyQuil, Benadryl, and Sudafed. This decision stems from findings that phenylephrine is ineffective when taken orally, although it remains effective in nasal spray form.

Dr. Randy Hatton, a professor at the University of Florida's College of Pharmacy, has been advocating for this change for two decades. He explained that phenylephrine became widely used after pseudoephedrine was restricted due to its potential misuse in methamphetamine production. However, patients have reported a lack of effectiveness with oral phenylephrine, leading to the FDA's proposed ruling.

The FDA has confirmed that while phenylephrine is safe, it is poorly absorbed in the body, with less than 1% of the dose being effective. Dr. Hatton emphasized that medications must be both safe and effective, and since oral phenylephrine does not meet the effectiveness criterion, it should be removed from shelves.

For those seeking relief from cold symptoms, Dr. Hatton suggests alternatives such as pseudoephedrine, which is available behind the pharmacy counter, or nasal sprays that contain phenylephrine, which can provide relief when used correctly. He cautioned against exceeding recommended doses of any medication, particularly combination products that may contain potentially harmful ingredients.

The proposed FDA ruling has sparked debate, with some critics arguing that it limits consumer choice. However, Dr. Hatton countered that offering ineffective products does not constitute a true choice, advocating instead for a market filled with safe and effective medications.

The FDA's ruling could take effect as soon as next year, potentially reshaping the landscape of over-the-counter cold treatments as consumers prepare for the winter season.