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.

WARNING: ARE MUSK, KENNEDY, AND TRUMP IGNORING THE GRAVE CONSEQUENCES OF SLASHING PUBLIC HEALTH FUNDING?

By Dr. Gerald Goldhaber • April 14, 2025
Recent budget cuts at the Health and Safety Science Services (HSSS) have sent shockwaves through the scientific and public health communities, threatening the very infrastructure designed to protect us from disease outbreaks, food contamination, and medical crises. These cuts have affected food inspectors, vaccine scientists, Alzheimer’s researchers, and experts studying bird flu, among others—positions that are essential to ensuring public safety and advancing critical medical research. The consequences of these decisions will be dire, potentially reversing years of progress and exposing society to increased health risks.

WARNING: IS ELON MUSK'S DEPARTMENT OF GOVERNMENT EFFICIENCY JEOPARDIZING AIR SAFETY?

By Dr. Gerald Goldhaber • March 12, 2025
As Elon Musk's Department of Government Efficiency (DGE) pushes for sweeping reforms and cost-cutting across federal agencies, concerns are mounting over the impact on critical public safety roles. Among the most alarming areas affected is the Federal Aviation Administration (FAA), where staff reductions may threaten the lives of millions of air travelers. The DGE, established with a mandate to streamline government operations and reduce bureaucratic waste, has come under fire for its aggressive downsizing tactics. Critics warn that essential safety personnel, including air traffic controllers, are being cut under the guise of efficiency, leaving the nation's airspace dangerously understaffed.

WARNING: WILL TRUMP'S SURGEON GENERAL SUPPORT IMPROVED ALCOHOL WARNING LABELS?

By Dr. Gerald Goldhaber • February 11, 2025
Biden Administration former Surgeon General, Vivek Murthy, on his way out of office, issued a Surgeon General's Advisory calling for new warnings on alcoholic beverages related to the cancer risk from consuming alcoholic beverages. Given that most individuals are unaware of the connection that consumption of alcoholic beverages can increase the risk for at least seven types of cancer, Murthy said in his advisory: "Given the conclusive evidence on the cancer risk from alcohol consumption and the Office of the Surgeon General's responsibility to inform the American public of the best available scientific evidence, the Surgeon General recommends an update to the Surgeon General's warning label for alcohol-containing beverages to include a cancer risk warning."

WARNING: TRUMP'S RE-ELECTION MEANS A DEREGULATORY NIGHTMARE FOR CONSUMERS

By Dr. Gerald Goldhaber • December 2, 2024
In my best-selling book, Murder, Inc.: How Unregulated Industry Kills or Injures Thousands of Americans Every Year...And What You Can Do About It , I propose a safety triad consisting of three components: manufacturers, regulators and consumers. All three must function properly in order to keep us safe. Manufacturers must produce and market safe (or safe as possible) products and warn us about any potential hazards so that we can make informed choices about whether or not to purchase their product and/or how to use it safely. Regulators , by imposing and implementing necessary rules and regulations, should hold manufacturers accountable for the above stated actions and to endure that they engage in "principled disclosure" by warning us about any potential hazards and dangers associated with their products. And, finally, Consumers , especially in the absence of well-meaning manufacturers or competent, well-intentioned regulators, must be highly diligent by researching products and learning about potential hazards prior to buying and/or using them. All three, manufacturers, regulators and consumers, must perform their jobs or the safety triad may fail to protect us and our loved ones. Think of a three-legged stool that distributes the weight of a person sitting on the stool, equally among the three legs. But what would happen if we leaned heavily to one side of the stool, essentially spreading the weight that was once borne by three legs to the two legs remaining braced to the floor. Unfortunately the third leg is no longer contributing to the stability of the stool, which may actually collapse because the two remaining legs may not be able to handle the amount of weight that was intended to be equally distributed among all three legs. 

WARNING: SOCIAL MEDIA IS ASSOCIATED WITH SIGNIFICANT MENTAL HEALTH HARMS FOR ADOLESCENTS

By Gerald Goldhaber • October 2, 2024
In an unprecedented, but, according to many social scientists and parents, a long overdue action, Surgeon General Vivek Murthy, in a June editorial in the New York Times, called for a warning label to be placed on all social media platforms. In the words of the Surgeon General:

WARNING: DOES YOUR REFRIGERATOR CONTAIN LISTERIA?

By Gerald Goldhaber • September 5, 2024
If you are one of the millions of Americans who recently purchased one of several Boar's Head Deli Products, you may have bought a product containing deadly listeria bacteria. At least nine people have died and 57 have been hospitalized from a listeria outbreak linked to deli meat, according to the Centers for Disease Control and Prevention. In late July, Boar’s Head, a deli meat and cheese company, expanded a previously announced recall to include at least 7 million pounds of deli products the company says may have been contaminated by listeria amid a nationwide outbreak. The recall spans 71 products and includes meat meant to be sliced at retail delis along with prepackaged meat and poultry products sold at retail locations, according to the U.S. Department of Agriculture.

WILL THE CHEVRON DECISION CREATE A DEREGULATORY NIGHTMARE FOR CONSUMERS?

By Gerald Goldhaber • August 6, 2024
In my best-selling book, Murder, Inc.: How Unregulated Industry Kills or Injures Thousands of Americans Every Year...And What You Can Do About It (Hartford, Ct.:PYP Press, 2020), I discuss the need for "principled disclosure" from corporations about potential hazards that could hurt or kill us. I also discuss the role we as consumers play by seeking information about those hazards and finally, the role various regulatory agencies must play to initiate and enforce meaningful regulations on industry so that they do, indeed, engage in "principled disclosure" (i.e., tell the truth). In order to carry out its mandate, any regulatory agency or department charged with the responsibility of protecting the general public or consumers or workers and so on, must be empowered to both set the safety and hazard warnings rules and take aggressive, impactful action when they are not followed. Unfortunately, the U.S. Supreme Court, in a landmark 6-3 vote last month, overturned a 60-year old decision, colloquially known as "Chevron", which has the potential to undermine our government's regulatory agencies' ability to hold corporations accountable. What is the Chevron Decision and how could it impact your safety and well-being? In a unanimous ruling, the Supreme Court ruled against energy giant, Chevron, who challenged the Clean-Air Act, and instructed lower courts to defer to federal agencies when laws passed by Congress are not crystal clear. The 40-year-old decision has been the basis for upholding thousands of regulations by dozens of federal agencies, but has long been a target of conservatives and business groups who argue that it grants too much power to the executive branch, or what some critics call the administrative state. In the decades following the ruling, Chevron has been a bedrock of modern administrative law, requiring judges to defer to agencies’ reasonable interpretations of congressional statutes. But the current high court, with a 6-3 conservative majority has been increasingly skeptical of the powers of federal agencies. With a closely divided Congress, presidential administrations have increasingly turned to federal regulation to implement policy changes. Federal rules impact virtually every aspect of everyday life, from the food we eat and the cars we drive to the air we breathe and homes we live in. For example, the Biden administration has issued a whole host of new regulations on the environment, including restrictions from emissions at power plants and from vehicle tailpipes. Those actions and others could be opened up to legal challenges if judges are allowed to discount or disregard the expertise of the executive-branch agencies that put them into place. When you consider who was advocating for the overturn of Chevron, it does not bode well for consumers and their safety: groups representing the gun industry and other businesses such as tobacco, agriculture, timber and homebuilding, were among those pressing the justices to overturn the Chevron doctrine and weaken government regulation. Can you imagine the FDA being defanged by Chevron-influenced lawsuits to the point where tobacco could sell their products to teens or resume advertising on television, a practice banned by Congress since 1970. Or imagine OSHA (Occupational Safety and Health Administration) regulations being stripped away that protect worker safety? Or a CPSC (Consumer Product Safety Commission) challenged on its stringent toy regulations that are aimed at infant choking hazards? Or a Department of Agriculture no longer able to inspect meat with the rigor that industry now faces? Or a NHTSA (National Highway Traffic Safety Administration) no longer able to regulate the safety of our automobiles, especially now as we address the feasibility and safety of self-driving vehicles?

CAN DEMENTIA BE CURED: NEW DRUG WITH NEW WARNINGS

By Gerald Holdhaber • July 16, 2024
CNN recently featured its medical expert, neurologist Sanjay Gupta, narrating a very thorough documentary entitled "The Last Alzheimer's Patient" which, over a 5 year period, collected data on the latest research related to dementia, highlighting advances in new medications as well as in lifestyle changes, both of which offer promising developments that may, in some cases, reverse or, at least stop the advance of Alzheimer's, the most common form of dementia. What is Alzheimer's Disease (AD)? According to the Yale School of Medicine, AD "is a progressive disorder that damages and destroys nerve cells in the brain. Over time, the disease leads to a gradual loss of cognitive functions, including the ability to remember, reason, use language, and recognize familiar places. It can also cause a range of behavioral changes."

WARNING: SUMMER FUN MAY LEAD TO SUMMER DANGERS!

By Gerald Goldhaber • June 6, 2024
The following story is from one of my cases. I have changed the names to protect my client's identity.

FOREVER MAY NOT BE FOREVER WITH EPA’S NEW PFA LIMITS

By Gerald Goldhaber • May 7, 2024
Last month, the Environmental Protection Agency (EPA) finalized strict limits on PFAS, so-called “forever chemicals”, in drinking water that will require utilities to reduce them to the lowest level they can be reliably measured. Officials say this will reduce exposure for 100 million people and help prevent thousands of illnesses, including cancers.
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