With winter setting in around much of the country, we are also gearing up for cold and cough season,

when people frequently reach for over-the-counter medicines.

But the FDA now says that a common, long-used ingredient in many of those medicines is ineffective and it should be removed.

As Stephanie Syr tells us, this proposed ruling could go into effect as soon as next year.

Phenolephrin is an ingredient in versions of popular cold medicines, including NyQuil, Benadryl, and Sudafed.

The FDA is proposing taking it off shelves not because it's unsafe, but because it doesn't work.

At least not when it's taken

as a pill or syrup. It can be effective when administered in a nasal spray. To help us understand

why the FDA is making this move, we're joined by Dr. Randy Hatton. He's a professor at the

University of Florida's College of Pharmacy who has been raising awareness about this issue for two

decades. Dr. Hatton, thanks so much for joining the NewsHour. I know you and a co-researcher have been

looking at this issue for years. I have to ask, why has phenolephrine become so commonplace in

cold and flu medicines if it doesn't work? and why have we all bought it for so long?

Yeah, you're right. Dr. Leslie Hedlis and I have been working at this for 20 years.

When we became aware of problems with oral phenylaphrine, after pseudoophedrine was moved behind the counter,

because of concerns where it could be used to make

methamphetamine in clandestine laboratory. So when pseudoephedrine was moved behind the counter,

phenylephrine was substituted for pseudoephedrine and became widely used. And that's when

patients started complaining about its lack of effectiveness. The FDA has ruled this ingredient safe. So why do you think it's important to get it off the shelves?

Yeah, it is safe because essentially it is not absorbed. It is absorbed at less than 1% of the dose that

is given. And that's why it doesn't work. So why should it be removed?

Because it doesn't work. Drugs on the market in the United States, whether they're over the

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