Whether it’s a headache, occasional heartburn or runny nose, we all know the routine: stop by the local drugstore on the way home and pick up some over-the-counter (OTC) medicine. Twist off the top, pop a few pills and hopefully get some quick relief. Perhaps some of us read the directions first, although most of us have been taking these drugs for years and already “know” exactly how to take them. Unlike prescription drugs, for which you generally need to see a doctor for a refill, OTC medications are for the most part freely available and you can pick them up without having to talk to anyone or obtain approval—just go to the store, pick it up and you’re on your way, which fits squarely within the routine of most fast-paced American families. For most ailments you probably don’t think twice about it, but what about those OTC products that used to require a prescription? How does a medication transition from requiring physician approval to being thrown in your cart with ordinary household products? Are consumers fully aware of the risks and side effects associated with these medications? Or proper dosage instructions?

Historically, there were no federal regulations to protect the public from dangerous drugs. The original Federal Food, Drug, and Cosmetic Act of 1938 did not even distinguish between prescription and OTC drugs. Rather, the law was focused broadly on overseeing several categories of drugs and ensuring that they were safe and effective. As quoted on the FDA’s website, “It was a menacing marketplace filled with products such as William Radam’s Microbe Killer and Benjamin Bye’s Soothing Balmy Oils to cure cancer,” says John Swann, a historian at the Food and Drug Administration in Rockville, Maryland. “Products like these were, at minimum, useless remedies that picked the pocket of the user, but they could also be downright harmful.”

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