WARNING: FDA RECOMMENDS REMOVING POPULAR DECONGESTANT FROM MARKET

If you or anyone in your family has used, uses or plans to use such over the counter (OTC) remedies for the flu or common cold as Theraflu, Robitussin, NyQuil, DayQuil, Mucinex, Sudafed or even some versions of Tylenol or Advil, you may want to read this newsletter very carefully.

The Food and Drug Administration (FDA) has just announced that it is recommending that a key ingredient found in the above cough, cold and flu products, oral phenylephrine (PE), be removed  after the agency's scientists concluded that the oral version of the drug is ineffective as a nasal decongestant.  The FDA's proposal comes more than a year after the agency's outside advisers voted against continued use of the ingredient, oral (not nasal spray) phenylephrine, citing concerns with the initial data used to support its approval and new data questioning its effectiveness.


"Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a news release. It's important to note that this isn't the final order. The FDA, with its recommendation, has opened up a 6-month period during which the public and any interested parties can submit comments to the FDA. After that period (which ends on May 7, 2025), the FDA will release it's final decision in the form of an order as to whether or not it is pulling products with the ingredient from shelves.


In a preemptive move, CVS stopped selling products with phenylephrine last year after an FDA advisory committee declared that it was ineffective. Other major pharmacies, including Walgreens and Rite Aid, still stock products containing the drug for now.


Although phenylephrine received FDA approval for over-the-counter use in the 1970s, its popularity surged in 2005 after legislation moved products that use a similar decongestant, pseudoephedrine – which, in large quantities, can also be used to make methamphetamine – behind pharmacy counters.



"The FDA would provide manufacturers with appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from the market," the agency said in its release.

 The Consumer Healthcare Products Association said Thursday it was "disappointed" in the FDA's proposal. The industry trade group renewed its claim that no changes "are warranted" for oral phenylephrine and cited previous FDA and advisory committee decisions that did not call for pulling the ingredient.


"PE should remain an available option for consumers, because Americans deserve the option to choose the safe and effective OTC medicines they prefer and rely on," Scott Melville, CHPA's president and CEO, said in a statement.


The FDA's proposal caps a push by pharmacy professors at the University of Florida who have urged the agency for years to pull the product, pointing to new data showing phenylephrine did no better than a placebo when swallowed. The latest data shows that only a tiny fraction of phenylephrine is absorbed into the body when digested from a pill or syrup containing phenylephrine. This is different from other formulations like the inhaled nasal spray versions of the drug, where larger percentages of the drug can make it into the bloodstream. The researchers also have questioned the initial studies that were run to prove the drug's effectiveness, though they acknowledge that it is safe at currently approved levels.


"Let me be clear, oral phenylephrine is not a safety risk," said Professor Hatton from the University of Florida, "It just doesn't work."


In a scientific review published very recently by the FDA, the agency's scientists concluded that past studies estimating that higher percentages of the drug could be absorbed during digestion were "an overestimate and based on outdated technology." Less than 1% of the drug is absorbed into the bloodstream after being swallowed, they estimated. Far higher doses could "be needed to achieve a clinically meaningful outcome which would raise significant questions about safety."


"Furthermore, there are no clinical data demonstrating that oral PE is effective as a nasal decongestant at any dosage," the FDA's scientists wrote.

As the Warnings Doctor (who has provided consulting advice to the FDA in the past), I would recommend that consumers looking for some relief from their cold or flu symptoms no longer purchase any product that contains PE. For true relief, I recommend several servings of my (or your) grandmother's chicken soup.

MAHA OR MASA? WHEN HEALTH POLICY LEAVES SCIENCE BEHIND

By Dr. Gerald Goldhaber • October 20, 2026
“Make America Healthy Again” is an appealing slogan. Who could oppose it? But slogans are not evidence, and good intentions are not a substitute for science. The question Americans should be asking is whether the policies associated with the MAHA movement are actually making Americans healthier—or whether some are moving public health in the opposite direction.

WHEN WARNING LABELS BECOME THE WARNING

By Dr. Gerald Goldhaber • September 30, 2026
We live in an age of warning labels. They are on ladders, coffee cups, toys, appliances, medications, clothing, furniture and virtually anything else we might buy. Some warnings are essential. Others are so obvious that they have become the stuff of comedy. We have all seen examples: a label on a cup warning that its contents may be hot. A hair dryer carrying a warning not to use it while sleeping. A package of peanuts warning that it contains peanuts. A chainsaw instruction manual cautioning users not to stop the blade with their hands. A Halloween costume warning that it is not fire-resistant. A label on an iron reminding us that the appliance becomes hot when turned on. Then there are warnings that seem to state the painfully obvious: “Do not put your fingers in the fan.” “Do not use a knife to cut yourself.” “This product is not intended to be eaten.” One particularly famous example involved a child’s Superman costume warning that it does not enable the wearer to fly. These warnings can be funny, but they raise a serious question: What happens when consumers become accustomed to treating warnings as jokes? The purpose of a warning is to interrupt ordinary behavior. It is supposed to make us stop, pay attention and recognize a danger that we might otherwise overlook. But if consumers encounter dozens of warnings every day—many concerning hazards that are already obvious—the warning itself can begin to lose its power. Think about the difference between two warnings. The first says: “Caution: Contents hot.” The second says: “This medication can cause potentially dangerous interactions with certain commonly used drugs. Consult a physician or pharmacist before taking it.” The first identifies a hazard virtually everyone understands. (The exception, however, is McDonald’s coffee which exceeds industry norms and is extremely hot, beyond what the average consumer would expect) The second communicates information that many consumers could not possibly know without being told. Yet both may appear in the same visual universe of labels, boxes, inserts and fine print. That creates what might be called warning fatigue . When people repeatedly encounter warnings that seem ridiculous or unnecessary, they may develop the habit of ignoring warnings altogether. The consumer learns, consciously or unconsciously, that “warning” often means “something obvious that lawyers wanted printed on the package.” That is a problem when the next warning really matters. 

FOREVER CHEMICALS IN YOUR MAKEUP BAG: THE HIDDEN DANGER OF PFAS IN COSMETICS

By Dr. Gerald Goldhaber • August 10, 2026
You probably don't think twice about your morning routine—a swipe of foundation, a coat of mascara, maybe some lipstick before heading out the door. But lurking in many of these everyday products is a class of synthetic chemicals that scientists call "forever chemicals," and their presence in cosmetics has become impossible to ignore.

A PREVENTABLE CRISIS: THE U.S. MEASLES SURGE AND THE COST OF ANTI-SCIENCE LEADERSHIP

By Ann K. • July 13, 2026
A Grim Milestone for American Public Health We are facing a public health emergency that was entirely preventable. According to updated data from the Centers for Disease Control and Prevention (CDC), the United States has recorded 2,170 confirmed measles cases in 2026—and we are only halfway through the year. This staggering figure nearly matches the 2,289 cases recorded across the entirety of 2025, representing a measles crisis on a scale this country has not seen in over three decades. Measles was declared officially eliminated from the United States in 2000, thanks to robust and widespread uptake of the Measles, Mumps, and Rubella (MMR) vaccine. Today, that monumental achievement is on the verge of being permanently erased.

WARNING LABELS FOR SOCIAL MEDIA: PROTECTING YOUR CHILDREN IN THE DIGITAL AGE

By Dr. Gerald Goldhaber • June 15, 2026
For decades, Americans have relied on warning labels to alert consumers to hidden dangers. Cigarette packages warn of cancer. Alcohol labels caution pregnant women. Medications disclose side effects. Yet one of the most powerful and potentially addictive products used by millions of children every day carries virtually no warning at all: social media. In 2024, as I wrote in the September, 2024 issue of this newsletter, then-U.S. Surgeon General Dr. Vivek Murthy called on Congress to require cigarette-style warning labels on social media platforms, arguing that parents and children deserve to know that excessive use has been linked to anxiety, depression, body image problems, sleep disruption, and other mental health concerns. He stated that social media had become an important contributor to the youth mental health crisis and that warning labels could help increase awareness among families. Unfortunately, that proposal has stalled under the new administration. The opportunity to provide parents with basic health information appears to have been abandoned just as evidence of social media's harmful effects continues to mount.

WARNING: USING AI FOR MEDICAL DIAGNOSES MAY BE HARMFUL TO YOUR HEALTH

By Dr. Gerald Goldhaber • April 30, 2026
Artificial intelligence (AI) is rapidly reshaping the landscape of healthcare, particularly in the realm of medical diagnosis. From analyzing medical images to predicting disease risk, AI-driven tools are increasingly being integrated into clinical workflows. While the potential benefits are substantial—improved accuracy, faster diagnoses, and expanded access to care—there are also meaningful risks that warrant careful scrutiny. Understanding both sides is essential for clinicians, policymakers, and patients alike.

LITHIUM-ION BATTERIES: A GROWING FIRE RISK IN OUR HOMES

By Dr. Gerald Goldhaber • March 31, 2026
Lithium-ion batteries power much of modern life. From smartphones and laptops to e-bikes, power tools, and even home energy storage systems, these compact and efficient batteries are everywhere. But as their use has expanded, so too has a serious and often underestimated danger: the risk of fire. Lithium-ion battery fires are not like typical household fires. They burn hotter, spread faster, and can reignite even after appearing to be extinguished. These fires are caused by a process known as “thermal runaway,” where damage, overheating, or internal defects trigger a chain reaction inside the battery. Once this process begins, it can release flammable gases, cause explosions, and produce intense flames that are difficult to control.

WARNING: THE TRUMP ADMINISTRATION’S EPA IS DISMANTLING REGULATIONS PROTECTING US FROM PFAS, PUTTING OUR LIVES AT RISK

By Dr. Gerald Goldhaber • February 27, 2026
1. Weakening National Drinking Water Standards  In April 2024, the EPA finalized the first federally enforceable National Primary Drinking Water Rule (NPDWR) for six PFAS, including PFOA, PFOS, PFHxS, PFNA, HFPO-DA (GenX), PFBS, and mixtures of these chemicals. These rules established maximum contaminant levels (MCLs) and required monitoring and treatment timelines for public water systems. Under Trump's EPA, this landmark public health rule is being undone :

THE SILENT WINTER THREAT: CARBON MONOXIDE POISONING DURING STORMS AND POWER OUTAGES

By Dr. Gerald Goldhaber • January 27, 2026
Winter in the Northern Hemisphere brings cold weather, snow, and often severe storms. These conditions can lead to power outages that last hours or even days. When electricity is lost and temperatures plummet, many households turn to alternative heating methods or portable power generators. While these actions are understandable, they can expose families to a perilous and often invisible threat: carbon monoxide (CO) poisoning . 

HOLIDAY FOOD SAFETY: PROTECTING YOUR FAMILY FROM SALMONELLA & LISTERIA THIS THANKSGIVING

By Dr. Gerald Goldhaber • November 24, 2025
As Thanksgiving approaches, kitchens across the country are about to come alive with the sounds and smells of holiday cooking. While this season brings family, gratitude, and plenty of delicious food, it also comes with a serious and often overlooked risk: foodborne illness. In the U.S., Salmonella and Listeria remain two of the most dangerous and persistent causes of food poisoning—especially during the holidays, when increased food preparation, crowded refrigerators, and large holiday meals create ideal conditions for bacterial growth.Whether you’re hosting your first Thanksgiving dinner or you’re a seasoned holiday chef, brushing up on a few key food safety practices can help you keep your loved ones healthy and your celebration memorable for all the right reasons.
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