It was touch and go for NyQuil’s manufacturer, Procter & Gamble, yesterday while a panel of experts met to decide its fate. The panel was considering whether to recommend the Food and Drug Administration (FDA) pull the popular, over-the-counter cold medicine from the market because a relatively small number of consumers ingest too much of the product which contains the pain medicine, acetaminophen. Overdoses of acetaminophen can cause liver failure in some persons (an estimated 458 fatal cases per year in the U.S. in the 1990s), and the FDA has been considering further limits on drugs, both prescription and over-the-counter, that contain this widely popular and highly effective pain medicine.
In typical nanny-state fashion, the FDA-empaneled experts were voting on whether the fact that .0000015 percent of the consuming public suffered fatal liver failure possibly related to acetaminophen overdoses, should justify inconveniencing the entire population of Americans that use popular and effective cold medicines.
While NyQuil survived this latest attack of the nanny state, the experts did recommend changing the doseage limits for acetaminophen products, and banning certain prescription medicines that combine that substance with other pain medicines. The FDA usually follows the advice of its empanelled experts.
The FDA of late has been flexing its regulatory muscles, even going so far last May as to accuse General Mills of violating federal drug labeling laws because boxes of its Cheerios product advertised the cereal might help reduce cholesterol. Just last month, President Barack Obama signed legislation into law that gave the FDA power to regulate tobacco products.
NyQuil may have dodged a fatal bullet this time, but with a newly energized FDA, now headed by a zealous, former New York City Health Commissioner (Margaret Hamburg), Procter & Gamble, General Mills, and every other company that manufactures an ingestible or inhaleable product had better gird for a long series of battles over at least the next three-and-one-half years.