- In November 2024, a New York federal judge dismissed around 100 lawsuits alleging that companies such as Procter & Gamble and Haleon marketed OTC decongestants containing phenylephrine, a supposedly ineffective ingredient. The judge ruled that the companies were not required to update their product labels with new efficacy information unless mandated by the FDA
- In September 2023, an FDA advisory panel concluded that phenylephrine, a common decongestant in OTC medications such as Sudafed PE and DayQuil, is no more effective than a placebo at relieving nasal congestion. This unanimous decision was based on modern studies that contradicted earlier research from the 1960s and 70s. The FDA is now considering whether to mandate the removal of all such products from the market
- In December 2023, House Republicans, led by Rep. Lisa McClain, initiated an investigation into the FDA's handling of phenylephrine. The inquiry seeks to understand the FDA's delayed action on over-the-counter cough and cold medications containing phenylephrine, which accounted for approximately USD 1.8 billion in sales in the previous year
- In December 2023, Family Dollar voluntarily recalled nearly 300 over-the-counter drugs and medical devices after discovering that these products were stored at incorrect temperatures before being shipped to stores in 23 states. Although no consumer complaints or reports of illness were filed, the recall was announced as a precaution
- In 2023, the FDA approved Narcan and RiVive, naloxone nasal sprays for the emergency treatment of opioid overdose, for over-the-counter use. This move aims to enhance consumer access to essential treatments and underscores the growing trend towards self-managed healthcare solutions
