FDA’s proposal could impact cold and allergy remedies on Michigan store shelves as oral phenylephrine is found ineffective for nasal congestion relief in cold medicine.
FDA Targets Ineffective Nasal Decongestant in OTC Products
The U.S. Food and Drug Administration (FDA) has proposed removing oral phenylephrine from over-the-counter (OTC) products used for nasal congestion relief, citing ineffectiveness. The decision follows a thorough review of decades-old data and more recent clinical studies showing oral phenylephrine’s inability to relieve nasal congestion. The proposal affects many common cold and allergy medications available to Michiganders and others nationwide.
FDA Review Finds Decades-Old Ingredient Lacking Efficacy
The proposed removal comes after last year’s FDA Nonprescription Drug Advisory Committee unanimously agreed that oral phenylephrine, found in several cold and allergy products, does not work as intended in its current dosage form. The committee’s review, based on modern clinical evidence, revealed a stark contrast from data used decades ago to establish the ingredient’s effectiveness.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), stated, “Based on our review of available data, and consistent with the advisory committee’s conclusions, we are proposing the removal of oral phenylephrine due to its ineffectiveness as a nasal decongestant.”
Impact on Michigan Consumers and Market Changes
For Michigan consumers, this could mean a significant change in options for treating cold symptoms. Many local pharmacies carry OTC products containing oral phenylephrine either alone or combined with other active ingredients like acetaminophen. However, the FDA clarified that its proposal solely addresses phenylephrine’s effectiveness, not its safety or the efficacy of accompanying ingredients.
In practical terms, if the FDA finalizes its proposal, manufacturers would be given a grace period to reformulate or remove products featuring oral phenylephrine. In the meantime, Michiganders can still purchase and use these products, with the FDA encouraging the public to submit comments during the review period.
Advice for Consumers Seeking Effective Alternatives
Dr. Theresa Michele, director of the Office of Nonprescription Drug Products, reassured the public that “a range of safe and effective treatments remain available to relieve congestion symptoms from colds and allergies.” Michigan residents are advised to consult with pharmacists or healthcare providers to find alternatives that work.
Notably, the FDA emphasized that the proposal does not affect nasal spray formulations of phenylephrine, which continue to be considered effective.
A Broader Regulatory Shift in Consumer Health
This move reflects a broader regulatory effort to modernize OTC drug standards and ensure consumer health products are backed by solid evidence. The outcome of this proposal could impact local drugstore shelves and influence choices available to Michigan consumers, pushing for greater efficacy in treating common ailments.
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