Published on October 09, 2023

FDA Rules Oral Cold Medicines Do Not Help Congestion

Autumn has officially arrived—and that means that cold and flu season is also officially in full swing. It is common knowledge that when you are feeling ill, you turn to the following remedies to feel better:

A bubbly drink

Chicken noodle soup

Daytime soap operas

And cold medicine

Yet, recently, the FDA ruled that over-the-counter cold and flu medicines are ineffective. Has everything we have ever been taught about taking cold medicine as an adequate cure been untrue?

Here are some important facts you should know about the FDA ruling and how cold medicine is now deemed less than effective.

What is the Ineffective Ingredient?

The active ingredient in Sudafed, Robitussin, Benadryl, Dayquil, and additional cold medicines is phenylephrine. After decades of promoting this ingredient as the key to helping ease the pain of congestion, extensive testing has proven it simply does not work.

Bayer, Johnson & Johnson, and other drug manufacturers may soon be forced to remove the items from stores. This will force cold sufferers to opt for medicine behind-the-counter pills—which carry their own risks—in addition to switching to drops or nasal sprays.

What Was the Ruling?

The Food and Drug Administration has revealed that all over-the-counter decongestants are virtually ineffective. They do not reduce the size of the nasal mucus membranes nor relieve congestion.

Now that the advisory panel has ruled on this matter, the oral products may soon be removed from shelves across the country. Nasal decongestants containing phenylephrine, however, will remain for public use and were not included in the advisory panel’s ruling. The FDA typically sides with the panel, and therefore, the medicine is assumed to be removed from being sold to the public in the near future.

Consumers are Frustrated and Disappointed:

Consumers have shared their unified disappointment after spending millions on a product that has been proven to not work as promised. How could this have been permitted to happen? Did the makers and manufacturers know that the active ingredient in the most popular oral cold medicines do not help consumer get relief from cold, sniffles and the flu?

Phenylephrine was first introduced in popular brands in 2006 after pseudoephedrine was removed from store shelves. The latter ingredient harbored an illegal substance, methamphetamine, and was ruled incredibly dangerous and addictive.

Although the first case of concerns about phenylephrine dates back to 2006, when the first consumer petition was filed, the Consumer Healthcare Products Association continues to argue that the drug should remain on store shelves. The CHPA argues that the testing is inconclusive and cites the “totality of the scientific evidence” in question. They remain stoic that the drug is effective.

Fueling More Problems:

Although the majority of people agree that the products should be removed from store shelves, there are other serious concerns. Since pseudoephedrine was removed as an over-the-counter option years ago, it lost its popularity as it is not a restricted product.

Now that the popular oral drugs people have relied on for decades may no longer be an option, some experts fear there will be a rise in the use of pseudoephedrine again. This ingredient is a main staple in the product of the illicit drug meth.

Bottom Line:

Now that the truth is out, any oral medicine that contains phenylephrine may be pulled from shelves in the coming months. Although several other options for decongestants exist, many consumers continue to feel duped into spending millions of dollars on products that are deemed ineffective and virtually worthless.