FDA Says the Decongestant in Your Medicine Cabinet Probably Doesn’t Work. Now What?

This ingredient found in popular versions of Sudafed, Dayquil and other medications has gained popularity since Congress made it difficult for people to obtain an effective oral decongestant. Now, lawmakers can correct that mistake before the winter cold and flu season arrives in full force.

In an effort to shut down homegrown meth labs in which people converted oral decongestants containing pseudoephedrine into methamphetamine, Congress 18 years ago passed the Combat Methamphetamine Epidemic Act. Under the CMEA, the Drug Enforcement Administration ordered all pseudoephedrine-containing products moved “behind the counter” and required pharmacists to register and track people who purchased them.

The DEA placed strict limits on the number and dosage of pseudoephedrine-containing products patients may obtain in 30 days. Until last year, Oregon and Mississippi had required residents to get a doctor’s prescription. But as often happened to the meth lab “cooks,” the methamphetamine law has become a spectacular fail, backfiring on its creators and harming innocent bystanders.

Lawmakers should admit it was a mistake and get rid of it.

Allergy drugmakers did not follow makers of cold medicines

When the Combat Methamphetamine Epidemic took effect in 2006, there were only two over-the-counter oral decongestants on the market: phenylephrine and pseudoephedrine. A third, phenylpropanolamine, was fading from the market after studies associated it with hemorrhagic strokes.

The CMEA effectively narrowed patients’ choices to one: phenylephrine.

So their customers could continue buying their products over the counter and avoid the stigma of registering to purchase pseudoephedrine, many drugmakers substituted pseudoephedrine with phenylephrine. For example, Sudafed, which manufactured pseudoephedrine, came out with Sudafed PE (for phenylephrine). Phenylephrine replaced pseudoephedrine in Nyquil Sinex Nighttime Sinus Relief.

Yet, the makers of Claritin‑D, a nonsedating antihistamine combined with pseudoephedrine, chose not to switch to phenylephrine. Their chemists ran tests on phenylephrine and found it ineffective when taken orally. They decided to stay behind the counter. Their competitors, Zyrtec and Allegra, made the same decision.

Then, in 2007, two academic pharmacists from the University of Florida looked at the studies the FDA relied on to declare oral phenylephrine safe and effective in the 1970s. They concluded that phenylephrine was no better than placebo.

A year had passed since the DEA moved pseudoephedrine, an effective oral decongestant, behind the counter. This was not a good time to tell millions of cold and allergy sufferers that the drugs they buy over the counter probably won’t work.

Responding to the pharmacists’ petition, the FDA convened a panel that determined there was “murky” evidence phenylephrine worked orally, but the evidence was inconclusive.

By 2015, when the University of Florida pharmacists saw the results of studies by Merck and other drug companies showing oral phenylephrine doesn’t work even at high doses, they asked the FDA to take oral phenylephrine off the shelves.

After the American Pharmacists Association and other groups joined the petitioners, the FDA convened an advisory panel eight years later, in April.

CVS removes decongestants containing phenylephrine. Now what?

On Sept. 12, decades after the FDA proclaimed oral phenylephrine safe and effective, the panel concluded that oral phenylephrine is no better than a placebo. Unlike pseudoephedrine, digestive juices break down the phenylephrine before it can be absorbed into the system and work.

It doesn’t take a conspiracy theorist to wonder whether the FDA didn’t want to undermine the newly minted Combat Methamphetamine Epidemic Act by telling cold and allergy sufferers they will all be facing limits on their access to oral decongestants. And it wouldn’t be the first time politics influenced the FDA.

It took more than a decade and a federal court order to get the FDA to let women of all ages buy Plan B emergency contraceptives over the counter in 2013, as academic physicians and FDA advisory panels had urged it to do.

Meanwhile, how’s the CMEA working to combat the methamphetamine epidemic?

The Mexican drug cartels soon took advantage of the new hole the law created in black market meth and figured out other ways to make methamphetamine more efficiently. One way is using phenyl‐​2‐​propanone, also called phenylacetone or P2P.

Meth-related drug deaths per 100,000 thus increased nationally by 1,400% between 2006 and 2020.

More than half of American households trust and use oral phenylephrine, accounting for an estimated $1.76 billion in sales last year. The FDA hasn’t yet decided to officially inform them they are wasting their money on phenylephrine or to order it off the shelves.

If it does, expect cold and allergy sufferers to be very upset when they learn how inconvenient the government will make it for them to get relief from pseudoephedrine. Last week, CVS announced that it will begin voluntarily pulling oral phenylephrine decongestants off its store shelves.

Congress can help the FDA extricate itself from this disaster. The CMEA isn’t working. It helped to increase meth-related deaths. Congress should repeal it.

Then drugs like Sudafed, Claritin‑D and others can return to the shelves and make America breathe again.