The FDA Is Finally Taking a Stance Against High-Risk Homeopathic Products

Homeopathic manufacturers take advantage of sick and vulnerable populations in criminal ways—and the FDA is, after much absence, starting to crack down.

The FDA Is Finally Taking a Stance Against High-Risk Homeopathic Products


Samuel Hahnemann discovered cinchona, Peruvian bark, while translating Scottish physician William Cullen’s book on malaria. The German doctor left a career in medicine because he objected to practices like bloodletting, which he considered ineffectual and barbaric. Upon leaving the establishment Hahnemann supported his family by translating medical textbooks—a linguist, he spoke nine languages. Cullen’s 1789 book, A Treatise on the Materia Medica, set off a light bulb that would forever change the trajectory of Hahnemann’s career.

Inspired by the possibilities of a less dangerous approach to healing, Hahnemann slathered cinchona over his body to induce malaria-like symptoms. It remains unproven that he really developed malaria; an inflammatory reaction is possible. Undaunted, he reasoned that it would be the same for any healthy individual. This experience became the foundation of homeopathy. The idea that “like cures like” was not new, but by being its champion Hahnemann created what would become a multi-billion dollar industry. 


Samuel Hahnemann, the father of homeopathy. (Getty Images)

Hahnemann’s method, potentization, remains the basis of homeopathy today. To understand this process, let’s consider the most popular homeopathic flu remedy on the shelves, Oscillococcinum. One of France’s top-selling medicines, it rakes in $20 million a year in America. Yet few people know what it actually is. 

Oscillococcinum is based on French physician Joseph Roy’s 1917 discovery of an oscillating bacterium he termed Oscillococcus in the blood of flu victims. Roy speculated that this bacterium was responsible for a host of diseases, ranging from eczema to cancer. Years later he discovered the same bacterium in the blood of a Long Island duckling. Never mind that no one else ever verified its existence; it was likely dust on the microscope slide. 

Roy had a vision and stuck with it, evidence be damned. Today the process of potentization to manufacture Oscillococcinum begins with the heart and liver of the Muscovy duck. Technicians mix one part duck heart and liver with one hundred parts sugar in water. Then the process is repeated two hundred times. Well, lactose is continually added in; that one part duck is the only active ingredient blended in at any point. 

Dilutions—a proving—for various remedies range in intensity. A homeopathic prescription claiming a potency of 6x means there’s one part active ingredient per million bits of sugar. By the time you get to 6c there is one part in ten trillion. By 13c no parts remain. A typical homeopathic medicine is 30c. Former U.S. Air Force flight surgeon and family physician Harriet Hall points out that at this level you’d need a container thirty times the sizes of the earth just to find one molecule of the initial substance. Oscillococcinum is 200c—pure sugar water.

In homeopathy, the less of an active ingredient, the stronger it is. Skirting the basic precepts of biology, most homeopathic remedies don’t only work because of placebo, they are placebo. Despite the fact that this knowledge hides in plain sight, the FDA continues to turn a blind eye, to the point where the FTC stepped in last year to require stricter regulations of claims being made on homeopathic packaging, which pull in nearly $3 billion per year in America. 

Until now, that is. The FDA announced that, in a rare recent instance of consumer protection, it's cracking down on marketing claims by manufacturers of homeopathic products. Homeopathy has long enjoyed a lack of surveillance, even though these products are legally subject to the same approval and misbranding requirements as pharmaceuticals. 

The problem with current regulation is two-fold. First, claiming sugar water is responsible for curing colds or any other ailments is irresponsible. The second is more dangerous: some products do contain active ingredients—ironic, since in homeopathic lore it is a weak proving—which have not been clinically tested. 

As FDA commissioner Scott Gottlieb puts it: 

In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients. 

Most homeopathic products will come through this unscathed, however. The FDA is targeting products with reported safety concerns, containing potentially dangerous ingredients, administered in ways other than oral or topical, marketed for the prevention of life-threatening diseases, aimed at vulnerable populations, or not meeting standards of quality, strength, or purity as those required under the law. 


FDA Commissioner Scott Gottlieb. (Getty Images)

This could lead to serious problems, says Timothy Caulfield, the Canada Research Chair in Health Law and Policy at the University of Alberta and author of Is Gwyneth Paltrow Wrong About Everything? While he’s happy the FDA is finally regulating homeopathy, he says that by overlooking clinically benign products it is inadvertently endorsing their efficacy. As he told me:

Do to resource constraints, they are prioritizing the high risk products. I understand the motivation for this policy. But I fear they are implicitly endorsing the low risk stuff—which is likely most of the homeopathic products. What is a needed is a clear, blanket policy that is built on the reality that homeopathy is science-free nonsense and that any claims of efficacy— at least beyond a placebo effect—are not founded on good evidence.

The rigors and constraints pharmaceuticals have to endure to get to market are for our protection, even if the pharmaceutical industry itself has been devious when extending patents and marketing ineffective products. Homeopathic medicine today in large part thrives due to consumer concern about Big Pharma—homeopathy was nearly decimated until magical thinking made a huge comeback in the 1960s. The response to growing corporate and governmental power created a mindset that anything coming from those camps must be tainted. 

That we search for solutions beyond pharmaceuticals is understandable. Yet homeopathic manufacturers are taking advantage of us in similarly criminal ways. We’re literally being sold sugar water to coat the bitter reality of the vitamin aisle’s most ineffective products. As with the rest of the sugar in the market, we gladly pay for it, ignorant of the damage it causes. 

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Derek Beres is the author of Whole Motion: Training Your Brain and Body For Optimal Health. Based in Los Angeles, he is working on a new book about spiritual consumerism. Stay in touch on Facebook and Twitter.

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Are we really addicted to technology?

Fear that new technologies are addictive isn't a modern phenomenon.

Credit: Rodion Kutsaev via Unsplash
Technology & Innovation

This article was originally published on our sister site, Freethink, which has partnered with the Build for Tomorrow podcast to go inside new episodes each month. Subscribe here to learn more about the crazy, curious things from history that shaped us, and how we can shape the future.

In many ways, technology has made our lives better. Through smartphones, apps, and social media platforms we can now work more efficiently and connect in ways that would have been unimaginable just decades ago.

But as we've grown to rely on technology for a lot of our professional and personal needs, most of us are asking tough questions about the role technology plays in our own lives. Are we becoming too dependent on technology to the point that it's actually harming us?

In the latest episode of Build for Tomorrow, host and Entrepreneur Editor-in-Chief Jason Feifer takes on the thorny question: is technology addictive?

Popularizing medical language

What makes something addictive rather than just engaging? It's a meaningful distinction because if technology is addictive, the next question could be: are the creators of popular digital technologies, like smartphones and social media apps, intentionally creating things that are addictive? If so, should they be held responsible?

To answer those questions, we've first got to agree on a definition of "addiction." As it turns out, that's not quite as easy as it sounds.

If we don't have a good definition of what we're talking about, then we can't properly help people.

LIAM SATCHELL UNIVERSITY OF WINCHESTER

"Over the past few decades, a lot of effort has gone into destigmatizing conversations about mental health, which of course is a very good thing," Feifer explains. It also means that medical language has entered into our vernacular —we're now more comfortable using clinical words outside of a specific diagnosis.

"We've all got that one friend who says, 'Oh, I'm a little bit OCD' or that friend who says, 'Oh, this is my big PTSD moment,'" Liam Satchell, a lecturer in psychology at the University of Winchester and guest on the podcast, says. He's concerned about how the word "addiction" gets tossed around by people with no background in mental health. An increased concern surrounding "tech addiction" isn't actually being driven by concern among psychiatric professionals, he says.

"These sorts of concerns about things like internet use or social media use haven't come from the psychiatric community as much," Satchell says. "They've come from people who are interested in technology first."

The casual use of medical language can lead to confusion about what is actually a mental health concern. We need a reliable standard for recognizing, discussing, and ultimately treating psychological conditions.

"If we don't have a good definition of what we're talking about, then we can't properly help people," Satchell says. That's why, according to Satchell, the psychiatric definition of addiction being based around experiencing distress or significant family, social, or occupational disruption needs to be included in any definition of addiction we may use.

Too much reading causes... heat rashes?

But as Feifer points out in his podcast, both popularizing medical language and the fear that new technologies are addictive aren't totally modern phenomena.

Take, for instance, the concept of "reading mania."

In the 18th Century, an author named J. G. Heinzmann claimed that people who read too many novels could experience something called "reading mania." This condition, Heinzmann explained, could cause many symptoms, including: "weakening of the eyes, heat rashes, gout, arthritis, hemorrhoids, asthma, apoplexy, pulmonary disease, indigestion, blocking of the bowels, nervous disorder, migraines, epilepsy, hypochondria, and melancholy."

"That is all very specific! But really, even the term 'reading mania' is medical," Feifer says.

"Manic episodes are not a joke, folks. But this didn't stop people a century later from applying the same term to wristwatches."

Indeed, an 1889 piece in the Newcastle Weekly Courant declared: "The watch mania, as it is called, is certainly excessive; indeed it becomes rabid."

Similar concerns have echoed throughout history about the radio, telephone, TV, and video games.

"It may sound comical in our modern context, but back then, when those new technologies were the latest distraction, they were probably really engaging. People spent too much time doing them," Feifer says. "And what can we say about that now, having seen it play out over and over and over again? We can say it's common. It's a common behavior. Doesn't mean it's the healthiest one. It's just not a medical problem."

Few today would argue that novels are in-and-of-themselves addictive — regardless of how voraciously you may have consumed your last favorite novel. So, what happened? Were these things ever addictive — and if not, what was happening in these moments of concern?

People are complicated, our relationship with new technology is complicated, and addiction is complicated — and our efforts to simplify very complex things, and make generalizations across broad portions of the population, can lead to real harm.

JASON FEIFER HOST OF BUILD FOR TOMORROW

There's a risk of pathologizing normal behavior, says Joel Billieux, professor of clinical psychology and psychological assessment at the University of Lausanne in Switzerland, and guest on the podcast. He's on a mission to understand how we can suss out what is truly addictive behavior versus what is normal behavior that we're calling addictive.

For Billieux and other professionals, this isn't just a rhetorical game. He uses the example of gaming addiction, which has come under increased scrutiny over the past half-decade. The language used around the subject of gaming addiction will determine how behaviors of potential patients are analyzed — and ultimately what treatment is recommended.

"For a lot of people you can realize that the gaming is actually a coping (mechanism for) social anxiety or trauma or depression," says Billieux.

"Those cases, of course, you will not necessarily target gaming per se. You will target what caused depression. And then as a result, If you succeed, gaming will diminish."

In some instances, a person might legitimately be addicted to gaming or technology, and require the corresponding treatment — but that treatment might be the wrong answer for another person.

"None of this is to discount that for some people, technology is a factor in a mental health problem," says Feifer.

"I am also not discounting that individual people can use technology such as smartphones or social media to a degree where it has a genuine negative impact on their lives. But the point here to understand is that people are complicated, our relationship with new technology is complicated, and addiction is complicated — and our efforts to simplify very complex things, and make generalizations across broad portions of the population, can lead to real harm."

Behavioral addiction is a notoriously complex thing for professionals to diagnose — even more so since the latest edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the book professionals use to classify mental disorders, introduced a new idea about addiction in 2013.

"The DSM-5 grouped substance addiction with gambling addiction — this is the first time that substance addiction was directly categorized with any kind of behavioral addiction," Feifer says.

"And then, the DSM-5 went a tiny bit further — and proposed that other potentially addictive behaviors require further study."

This might not sound like that big of a deal to laypeople, but its effect was massive in medicine.

"Researchers started launching studies — not to see if a behavior like social media use can be addictive, but rather, to start with the assumption that social media use is addictive, and then to see how many people have the addiction," says Feifer.

Learned helplessness

The assumption that a lot of us are addicted to technology may itself be harming us by undermining our autonomy and belief that we have agency to create change in our own lives. That's what Nir Eyal, author of the books Hooked and Indistractable, calls 'learned helplessness.'

"The price of living in a world with so many good things in it is that sometimes we have to learn these new skills, these new behaviors to moderate our use," Eyal says. "One surefire way to not do anything is to believe you are powerless. That's what learned helplessness is all about."

So if it's not an addiction that most of us are experiencing when we check our phones 90 times a day or are wondering about what our followers are saying on Twitter — then what is it?

"A choice, a willful choice, and perhaps some people would not agree or would criticize your choices. But I think we cannot consider that as something that is pathological in the clinical sense," says Billieux.

Of course, for some people technology can be addictive.

"If something is genuinely interfering with your social or occupational life, and you have no ability to control it, then please seek help," says Feifer.

But for the vast majority of people, thinking about our use of technology as a choice — albeit not always a healthy one — can be the first step to overcoming unwanted habits.

For more, be sure to check out the Build for Tomorrow episode here.

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Credit: World Values Survey, public domain.
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