Why It Matters: These Are Popular Staples of the Medicine Cabinet.
Every cold and flu season, millions of Americans reach for these products, some over decades. The decongestant is in at least 250 products that were worth nearly $1.8 billion in sales last year, according to an agency presentation. Among the products: Sudafed Sinus Congestion, Tylenol Cold & Flu Severe, NyQuil Severe Cold & Flu, Theraflu Severe Cold Relief, Mucinex Sinus Max and others.
The ingredient has long been considered safe and effective under an old, outdated agency standard, and the F.D.A. still says that it is safe.
And it is still widely considered effective as a nasal spray, or when it is used in surgery and to dilate the eyes. It is destroyed in the gut, though, scientists have concluded.
If the agency decides the decongestant should be eliminated from products, it could significantly disrupt the market for the makers of cold medicines if they do not have enough time to replace it in popular items.
What’s more: It could possibly renew widespread use of an alternative, pseudoephedrine, which was placed behind store counters or in locked cabinets because it was often used in illicit meth labs.
Background: Researchers Tried for Years to Get Rid of This Ingredient.
This issue has been simmering at the F.D.A. for decades. In 2007, Dr. Leslie Hendeles and several other pharmacists at the University of Florida petitioned the agency to remove the drug from the market.
Dr. Hendeles, now an emeritus professor, said in an interview on Tuesday that he had been evaluating the ingredient since 1993.
“The bottom line is quality research has told the true story about phenylephrine,” he said.
The F.D.A. has formally now concluded that phenylephrine, when taken orally, is “not effective as a nasal decongestant.”
For consumers, the potential benefits of ending use of the ingredient, the agency suggested, would include avoiding unnecessary costs or delays in care by “taking a drug that has no benefit.”
The Consumer Healthcare Products Association, which represents companies that make over-the-counter drugs, disagreed, saying in a statement that the ingredient was safe and effective. The organization said pulling the ingredient would have the “negative unintended consequences” of sending patients to doctors and pharmacists for problems they might otherwise treat themselves — or of getting no treatment at all.
“Simply put, the burdens created from decreased choice and availability of these products would be placed directly onto consumers and an already-strained U.S. health care system,” according to the statement from Marcia D. Howard, the group’s vice president of regulatory and scientific affairs.
What’s Next: It’s Up to the F.D.A. to Pull the Ingredient.
It could be a while before any changes are announced.
But the agency has already shown its hand, by declaring the ingredient ineffective. But now, F.D.A. officials will mull the comments and opinions of its panel experts before preparing a final decision.
As often happens whenever the F.D.A. is poised to impose a regulatory move that will affect the bottom line of major corporations, efforts to delay a decision, including lawsuits and lobbying Congress and the White House, will probably occur. The agency also may give the drug companies a grace period to swap ingredients in products, if required.