What the FDA doesn’t know about alternative medicine—thanks to politics—could kill you

“Homeopathic medicine is rarely a single vitamin or plant extract, but a cocktail of substances that can occasionally kill people.”
“Homeopathic medicine is rarely a single vitamin or plant extract, but a cocktail of substances that can occasionally kill people.”
Image: Reuters/Phil Noble
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In 2014, Seattle Seahawks quarterback Russell Wilson took a hard hit to the head during a conference championship game against the Green Bay Packers. The following day, however, Wilson had no serious head injury.

“I believe Recovery Water helped prevent me from getting a concussion based on a bad hit!” he tweeted, referring to a product he endorses. No matter that Wilson is one of the most physically gifted and resilient athletes in the world. The company’s website is full of the suggestive, overly-technical language that alternative medicine manufacturers hide behind—electro-kinetic modification, nano-sized bubbles, and a slew of things that nobody can understand because it is ultimately meaningless.

And although that pseudo-science probably just means that Recovery Water is just a lightly carbonated tap water put under an electric charge, it belongs to the roughly $50 billion American alternative medical industry, along with dietary supplements—extracts, vitamins, and crushed herbs, among other things—and homeopathy—the practice of diluting similar substances with water.

For the vast majority of the 20th century, alternative medicine practitioners and seekers remained relatively small in number, and therefore required very little oversight, which allowed the industry to remain largely unregulated as it eventually grew to its current size. In the last five years the European Union has cracked down on alternative medicine, imposing stern regulations on herbal remedies. Canada’s department of government for health actively reviews substances for safety and efficacy. However, none of these measures have been taken in the United States, and will not be for the foreseeable future. It is not because the FDA refuses to evaluate these substances; rather it is because because the alternative medicine industry is protected by various laws that make sure the FDA does not have the authority to evaluate their products. Lyndsay Meyer, a spokesperson for the FDA, tells me that to address this $40 billion industry the FDA must rely on a team of 24 people and a budget of less than $5 million. It is time for the FDA to be untethered from these laws so that it can properly evaluate substances intended to enter our bodies.

In 1994, the Dietary Supplement Health and Education Act established the framework by which the FDA deals with  supplements. Meyer tells me that, with this act, Congress does not allow the FDA to evaluate dietary supplements; this means that although they can regulate the manufacturing processes and require that makers submit certain paperwork, they cannot evaluate the substances themselves for anything whatsoever. This is why the disclaimer “This product has not been evaluated by the FDA” is so ubiquitous. “They are held to good manufacturing practices, and labeling requirements, but in terms of someone looking at them for safety or efficacy,” Meyer says, “that is not something the agency has been given the authority to do.” There is a deeply troubling epistemological problem presented in the fact that the FDA exists to monitor our food, drugs, and cosmetics for safety and efficacy, but by law must ignore an entire aisle of the pharmacy.

Although the majority of supplements are things like vitamin D, iron, calcium, and niacin—which may not be evaluated by the FDA but are generally acknowledged to be necessary nutrients—there are also substances such as echinacea, a crushed flower marketed as a cure for the common cold that isn’t any more effective than waiting four days for your cold to go away on its own.

Lately, vitamin water drips are in vogue. The cocktails of water, magnesium, zinc, and other elements and minerals are available at clinics and promise restorative effects, even though it has long been proven that the human body can obtain all necessary nutrients from a healthy diet, and even though studies have suggested that the water drips are no more effective than placebos. In short, consumers will spend hundreds of dollars to have an unevaluated bag of intravenous water inserted into their arms by a non-professional, without any real understanding of what it does other than “promote health,” which seems to be a phrase as ubiquitous in alternative medicine as the FDA’s disclaimer. Even alcohol and illegal drugs—however harmful—have a recognized, concrete effect on the body.

Even worse, a 2015 investigation of GNC, Target, Walmart, and Walgreens by New York’s attorney general showed that only 21% of tested supplements had any trace at all of the plant advertised on the label. The vast majority of botanical supplements aren’t even what they claim to be.

Alternative drug manufacturers also have a luxurious 30 day window after going to market to prove that their substances are safe, unlike real medicine which must undergo years of rigorous trials before being brought to market. I suspect this is because if any alternative medicine were subject to the standard research and development procedures of real medicine, it would probably be laughed out of every laboratory in the country before even reaching clinical trials.

And yet, dietary supplements are, for the most part and with a few rare exceptions, nothing more than money drains whose presence on the market, one could argue, creates an order of financial Darwinism—maybe you don’t deserve to hold onto your money if you are going to spend it on supplements and extracts. The FDA doesn’t exist to save you from yourself, and after all, supplements will likely do nothing—which is to say they probably won’t kill you if you take them. They might, however, cause your urine to change colors.

The freedom that the homeopathic industry has sounds almost apocalyptic, especially because homeopathic medicine is rarely a single vitamin or plant extract, but a cocktail of substances that can occasionally kill people. Thanks to the Federal Food, Drug, and Cosmetic Act law, manufacturers of homeopathic drugs have few restrictions: they must use ingredients in the Homeopathic Pharmacopoeia, must follow rules of proper dilution, and abide by the principles of homeopathy—rules I imagine are enforced by a league of people resembling the union of magicians in South Park. In theory, so long as one follows these principles—which were not even established by the FDA—one could market a single ingredient homeopathic remedy that is mostly water and claims to cure Ebola without any real legal repercussions.

Making outrageous claims for alternative medicine is considered health fraud, except in the field of homeopathy. “All prescription and non-prescription products labeled as homeopathic go to market without FDA approval,” Meyer tells me. They cannot ban homeopathy, although the FDA website also claims they it is “not aware of scientific evidence to support homeopathy as effective.”

Nothing significant has been done about this nearly $10 billion industry, and we accept its terms almost without question, which suggests that public acceptance of homeopathy rests almost entirely on the idea that none of it does anything at all. What most consumers do not know is that homeopathic remedies often sit on pharmacy shelves beside other over-the-counter drugs. Zicam, a popular cold medicine that sits on shelves next to Benadryl and Nyquil, is in fact a homeopathic remedy. Some users have experienced a loss of smell as a result of using the drug. Another common, well-disguised homeopathic drugstore product is asthma spray, such as the one from Safecare available at most Walgreens, which suspiciously resembles an inhaler. This is a deadly bait and switch. These sprays are not FDA-approved asthma treatments, and yet their presence on pharmacy shelves obfuscates this fact. Allowing consumers to accidentally choose a substance that appears to be an ordinary over-the-counter drug but is in fact a homeopathic snake-oil remedy seems almost like criminal negligence.

This year, Hyland’s popular infant teething tablets have been brought to the attention of the FDA due to connections with infant seizures and even several deaths (the FDA has since warned against these tablets). Several years ago another brand of teething tablets were found to contain toxic levels of belladonna—also known as deadly nightshade, a plant that was used in early warfare to make poison-tipped arrows. Other homeopathic ingredients include poison ivy leaf, mercury, arsenic, and anthrax. (Update: On the 27th of January the FDA officially confirmed the presence of toxic levels of belladonna in Hyland’s teething tablets.)

Our conception of the industry is far too generous: at best homeopathic remedies do nothing. At worst, they can kill you. And the absence of explicit disapproval from the FDA constitutes a sort of tacit approval. If they haven’t banned it, logic stands that they must not be so bad. And it’s mind-boggling that such a simple intellectual gap can be so easily bridged regarding a substance that could kill your child.

The problem with banning this entire industry is not only that it would be a regulatory, financial, and legislative nightmare. Alternative medicine, by presenting itself as a natural, more holistic approach to the science of medicine, has created for itself a aura of honesty. Alternative medicine pretends to be a return to the medicine of yesteryear, before processed foods and drugs came along and trashed our bodies. Sam Schulte, who studies the history and philosophy of science at The University of Chicago suggests that alternative medicine uses this as a window into our bodies and wallets:

Homeopathic medicine emerges in relationship with the professionalization of medicine in the 20th century. Part of calling it natural isn’t just saying that natural is better; written into that logic is a mistrust of the medical establishment.

The alternative medicine industry fills this hole nicely, and Schulte also says that the American Medical Association’s taking control of and regulating the entire medical industry in the 20th century provides a very convenient narrative for alternative medicine merchants who want to set themselves apart from the establishment.

This is also why snake oil merchants can have great success with the uninsured and with immigrants. A popular New York City radio reggae station, Irie Jam, dedicates most of its on-air time to selling credit repair packages and substances like one called Biolife to listeners who will almost unquestionably trust the wisdom from this voice of their home. And because the American medical community has not done much to earn the trust of poor, uninsured black immigrants, Biolife seems like a good alternative to the medicine that so often doesn’t seem to work. “When your doctor tells you you have prostate cancer,” I once heard the DJ say on Irie Jam, “When he says it’s time to get your affairs in order, what you have to do is try the Biolife cleanse.” And like any age-old traveling medicine show, the announcer will slowly begin to reduce the price on air to tell you what a good deal it is. If a doctor has given you a death sentence, no amount of water and sawdust will cure you.

This, perhaps, is the most sinister aspect of homeopathy and alternative medicine. They feed on those who have lost hope. The vast majority of diseases they purport to treat are difficult or even impossible to cure: chronic back pain, headaches, the common cold, and even terminal illnesses.

One of the most popular names in homeopathy is Dr. Sebi, who sells a cell food package that he claims can cure AIDS, cancer, lupus, sickle cell, herpes, and so much more. Although he died earlier this year, his brand still exists, and among his slew of celebrity endorsements were Common and Michael Jackson. The substances the company offers, I am told by a salesperson over the phone, are a combination of restorative cleanses and minerals.

Sebi, it should be noted, was not a medical doctor, nor was he a PhD. And what his target diseases all have in common is that they are incurable. Dr. Sebi offers one last hope. Of course, a quick phone call to his organization will make clear that all the cell food packages—which go up to $1,500 a month—all seem to contain the same ingredients, regardless of which disease you have. I am also told over the phone that different packages are designed for different diseases, but there is no clear evidence that this is the case. Sebi even sells products that contain lily of the valley, which is literally poison. Of course one could argue that chemotherapy is poison too, but unlike lily of the valley, it isn’t just poison. The FDA wouldn’t allow Pfizer to sell arsenic tablets that have a low enough dose of arsenic that it won’t kill you but still won’t do anything positive for you either. So why do people like Sebi get a pass?

And because occasionally homeopathic drugs present a health crisis and come to the attention of the FDA when they are not properly diluted, the 30-day regulatory window for new alternative medicines could create a true disaster if something like lily of the valley were not diluted to non-toxic levels.

The term “snake oil” stems from a popular product 200 years ago that claimed viper oil was a sort of panacea. You probably couldn’t pay anybody taking $300 vitamin drips or blowing $18,000 a year for Dr. Sebi’s Cell Food to consume viper oil. That’s because the idea of taking anything from a highly venomous snake sounds crazy. And as it turns out there wasn’t anything in most snake oil but grease, pepper, and camphor, which nicely reflects the similar, more modern narrative of taking substances that at best contain nothing but food products and at worst are poison.

It would be foolish to say that alternative treatments never work, as would it be to cast away unconventional practices that have so often led to medical breakthroughs. However, successful treatments that deviate from the standard come from minds with a deep understanding of real medicine, not from the untrained suppositions of homeopaths. If the FDA were given authority to evaluate these substances we’d be left with a few essential nutrients on our shelves. The rest should be illegal to sell. Perhaps one day the US government will allow the FDA to regulate all medical products. But until then, let me tell you, I’ve managed to extract the essence from a rare detoxifying root found only in the rainforest, and for the low price of $99 I can cure everything that’s ever ailed you.