United States: The FDA has suggested that manufacturers stop using the active ingredient called oral phenylephrine because it may not actually do anything for nasal congestion and is present in many over-the-counter cold and cough remedies.
Major Cold Meds Affected
Phenylephrine can be found in products such as Benadryl, Advil, and Tylenol, but the FDA recommendation concerns only the oral form of the drug and not nasal sprays. This came after an 0r9 ruling made by a team of experts in the previous year, that phenylephrine is ineffective when taken orally as a nasal decongestant, as reported by USA Today.
Public Comment and Reformulation Period
They currently have time for either a reformulation or coming up with new formulations of their products or request the FDA recall formulations that they have submitted. For now the different companies that deal with products with oral phenylephrine can go ahead and continue promoting their products as nasal decongestants.
Reaction from the Consumers and Legal Cases
The Consumer Healthcare Products Association has said that it is disappointed by the FDA’s decision while pointing out it will study the proposed order and provide feedback. Large companies such as Procter &Gamble and GSK have had claims by consumers over aromatized phenylephrine products, as reported by USA Today.