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Enlarge / A box of Sudafed PE sinus pressure and pain medicine containing phenylephrine is displayed for sale in a CVS Pharmacy store in Hawthorne, California, on September 12, 2023. (credit: Getty | PATRICK T. FALLON)

Drug store giant CVS revealed late last week that it is voluntarily pulling some common cold and flu medicines from its shelves because they don't work—while many other ineffective products remain on the shelves.

The move by CVS comes after an advisory panel for the Food and Drug Administration last month voted unanimously that the common decongestant, phenylephrine, is ineffective at treating a stuffy nose. But it comes ahead of the FDA itself acting on the vote, which will likely lead the agency to revoke phenylephrine's approval, eventually.

In a statement to Ars, a CVS spokesperson suggested the FDA advisory panel's vote was the impetus for the change, but that it would "follow direction from the FDA."

"We are removing a small number of oral decongestant products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores but will continue offering many other oral cough and cold products to meet consumer needs," CVS's statement read. It didn't provide additional details on which or how many products would be removed, or when the removals would be complete.

The culling of phenylephrine products from drug-store shelves is a long-sought win for both researchers and consumers. Since at least 2007, researchers have expressed doubt about the effectiveness of phenylephrine, which is in popular oral medicines with brand names including Sudafed, Mucinex, Nyquil, and Benadryl. The small studies from the 1960s and 1970s that formed the basis of the FDA's initial approval in 1976 were found to be seriously flawed. And three large clinical trials since 2007 showed the drug doesn't work. Pharmacological studies showed why: Phenylephrine is highly metabolized in the gut, with less than 1 percent of active drug remaining bioavailable. Consumers, meanwhile, were largely in the dark, spending nearly $2 billion in 2022 on these products that researchers have said for years don't work.

But as these useless drugs finally vanish from CVS shelves, left behind is an entire class of products that are equally useless: homeopathic products.

“Snake oil” remains

These bogus treatments are based on centuries-old pseudoscience and have repeatedly been proven to be no more effective than placebo. In fact, if they were to prove effective, it would upend fundamental scientific understandings. For decades, consumer advocates and watchdogs have railed against them, yet these products are readily available on the shelves of every major drug store.

Homeopathy relies on two false ideas: the "law of similars" aka "like cures like," meaning a substance that causes a specific symptom in a healthy person can treat conditions and diseases in an ill person with that same symptom; and the "law of infinitesimals," which states that diluting a supposedly curative substance renders it more potent at treating medical conditions. As such, homeopathic products often start with bizarre, sometimes toxic substances that end up being diluted into oblivion in ritualistic procedures. The result is simply water or inactive filler ingredients. Homeopaths have acknowledged this and sometimes counter that water molecules have a "memory" of substances (they don't).

A homeopathic product lurking on a CVS shelf alongside real medicines. (credit: CFI)

Sound absurd? It is. And yet, homeopathic products are not only available in major drug stores and retailers around the country, they're often sold on the same shelves, side by side with evidence-based medicines that have gone through rigorous FDA safety and efficacy evaluations.

The FDA does have the authority to regulate homeopathic products. But, based on the 1938 Food, Drug, and Cosmetic Act, homeopathic products are generally considered exempt from pre-market FDA safety and efficacy reviews as long as the active ingredient is included in the Homeopathic Pharmacopoeia, a published list of substances approved by homeopaths. As such, homeopathic products enter the market without any FDA review—and sit on shelves with FDA-approved, evidence-based medicines.

"Most people don't know what this stuff is," Nicholas Little, vice president and legal director for the consumer advocacy organization the Center for Inquiry (CFI), said of homeopathic products in an interview with Ars.

Double standards

Little and CFI are currently engaged in a lengthy legal battle with CVS and Walmart, in which they're suing the retailers to try to get them to at least physically separate homeopathic products from effective, FDA-approved medications and provide clear information to consumers about what homeopathy actually is—which in CFI's words is "snake oil."

To see CVS remove phenylephrine-containing medicines over ineffectiveness, but not homeopathic products, immediately drew some questions from the advocacy organization.

"I want to ask CVS why they draw the distinction between these over-the-counter cold medicines that the FDA says don't work and these other over-the-counter homeopathic... products that the FDA also says don't work. Why do you draw that difference? Is it a business decision? They're the only ones that can answer that," Little said.

CVS declined to answer when Ars asked why the companies aren't removing homeopathic products in addition to some phenylephrine-containing products over ineffectiveness.

But Little makes clear that CFI isn't necessarily trying to get homeopathic products stripped from shelves. They will be happy if retailers simply provide consumers with information on homeopathic products so they aren't duped into buying them, thinking they're similar to effective, FDA-approved medications.

"I know so many people… hell, I've done this myself, I've bought [a homeopathic] product by mistake," Little said. In a trip to the drug store while sick or as a weary parent of a miserably ill child, it's easy to mistakenly pick up a homeopathic product in haste or the fog of infection. They're not only right next to evidence-based drugs, they often have comforting images and appealing, yet meaningless, labels like "natural." They sometimes tout having no side effects.

"Of course there are no side effects, there's nothing in it," Little noted.

Diluted protections

And even consumers who try to do their due diligence and read the labels may still be in the dark about what's in the products. The starting ingredients are usually written in Latin, and their dilutions are described in obtuse homeopathic nomenclature, such as "200C."

One of Little's favorite examples is Oscillococcinum, a homeopathic product sold as a cold and flu treatment by Boiron, one of the largest manufacturers of homeopathic products worldwide. (You can buy it at CVS, Target, Walgreens, etc.) The "active ingredient" in Oscillococcinum is anas barbariae—which, in case you didn't know, is an extract made from the heart and liver of a Muscovy duck. There's insufficient evidence to suggest duck organ extract is effective against cold and flu. And, as Little and CFI noted in a letter to the FDA last month, the anas barbariae in Oscillococcinum is nonexistent. It is:

prepared to a homeopathic dilution of 200C, meaning, in plain English, that there is one part duck offal to 10⁴⁰⁰ parts of water in the “treatment.” Given that research estimates there to be between 10⁷⁸ and 10⁸² [atoms] in the entirety of the observable universe, it is a physical impossibility for there to be a single atom of duck offal left in the product. Oscillococcinum is nothing more than a sugar pill.

Little and CFI's letter concluded by urging the FDA to remove Oscillococcinum and other bunkum homeopathic products from the market. In the interview with Ars, Little said the organization is pursuing the lawsuits against CVS and Walmart in hopes it can move the process along faster than the sluggish pace of bureaucracy at the FDA, which also struggles with limited resources. Still, the lawsuits are also expected to be a lengthy process. They're currently in the discovery process, and Little said he's anxious to directly question the pharmacy giant's decision to remove phenylephrine and not homeopathic drugs.

For now, Little is pleased to see some movement from the FDA and CVS on phenylephrine. "Congratulations to CVS for being responsible and looking after customers on this—that's great, big props to them," he said. "Now just tell them to do the same on homeopathy."

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