The FDA vs. Homeopathy: Are Homeopathic Treatments Safe?

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In everyday conversation, the term “homeopathic” has come to be associated with words like “natural,” “herbal,” or even “safe.” But to put homeopathy in such simple terms is deceptive—the concept is much more complex than many people realize. Despite the intricacies of the practice, homeopathic treatments make it to drugstore and supermarket shelves without undergoing the rigorous testing that other over-the-counter medications are subject to. But that could soon change.

What’s happening with homeopathic treatments?

The Food and Drug Administration (FDA) recently held two days of public hearings on homeopathic treatments, taking testimony on whether these products should be regulated the same way over-the-counter medications are.

Although homeopathic treatments have had to comply with certain FDA standards since the introduction of the 1938 Food and Drug Act, they are not regulated the same way that other over-the-counter drugs are, and can be marketed without FDA approval in the US. The last time the FDA reviewed homeopathic products was in 1988, when it issued a policy guide allowing “natural” remedies to be sold without pre-market approval.

The FDA continued to accept written or emailed comments on the issue until June 22nd, and if regulations are tightened on homeopathic treatments, a few notable changes will go into effect. The manufacturers of new homeopathic medicines will have to demonstrate the safety and effectiveness of their products before they can be sold in stores. Manufacturers of existing homeopathic products will also be affected—the FDA will review all labels of current medications to ensure they comply with the stricter regulations.

What is homeopathy?

Founded in 18th century Germany, homeopathy is a medical philosophy rooted in the notion that the body has the ability to heal itself. Homeopathic treatments are based on the principle that “like cures like”: If a particular substance causes symptoms in a healthy person, a very diluted amount of that substance may enhance the body’s healing process. Homeopathic practitioners also abide by the “law of minimum dose,” meaning, the lower the dose of the medication, the greater its efficacy.

There are two  types of homeopathy: acute homeopathy and constitutional homeopathy.  Acute homeopathy uses homeopathic treatments to treat temporary health issues like burns, skin irritations, and sprains, colds, flus, and coughs. Constitutional homeopathy is the holistic treatment of a person based on past and current symptoms, and is thought to treat chronic and recurrent problems and prevent future occurrences.

“Homeopathy is a complex system of medicine with a unique underlying philosophy and distinctly non-allopathic approach to diagnosis and treatment,” says One Medical Group’s Erica Matluck, ND, FNP. “Most homeopathic products on the market are better suited to acute homeopathy, but in my experience, homeopathy truly shines in the constitutional domain, so the selection of products on the market is a poor reflection of the potential benefits of homeopathy.”

Because constitutional homeopathy involves treatments tailored to the individual, it requires the skill and guidance of a trained expert; Matluck believes that reducing homeopathy to its most marketable form in one-size-fits-all treatments doesn’t do the nuanced system justice.

Are homeopathic treatments safe and effective?

Critics of current regulations have called attention to the fact that the FDA has issued nearly 40 warning letters regarding the safety of homeopathic products since 2009. The agency has issued warnings about teething tablets, asthma remedies, and cold products, although One Medical’s Gordon Sanford, PA, believes many of the incidents may have occurred because of the lack of homeopathic training available in the US, forcing many people with an interest in homeopathy to educate themselves. “Subsequently, many of these medications were used incorrectly and for the wrong purpose, leading many in the US to believe that homeopathy was not effective,” he says. “The regulation of these medications might not be a bad thing because it may force companies to show efficacies of the medications that they are trying to sell. This may increase the proper use of many of these combination products, which in turn is good for the consumer.”

While Sanford and other advocates believe homeopathic treatments can be beneficial in the right hands, there isn’t much scientific evidence to support the claims, fueling doubt in critics. Despite the fact that US adults spend dearly on homeopathic medicines ($3 billion in 2007), according to the National Center for Complementary and Integrative Health, the treatments are difficult to research and there is little evidence to support homeopathy as an effective treatment for any specific condition.

And, cautions One Medical’s Malcolm Thaler, MD, “The potential harm of opting for a homeopathic treatment isn’t just any potential side effects of the treatment, which presumably are minimal, but rather foregoing standard treatment that has proven effective. If a patient’s condition is not adequately treated, a potentially serious condition could become worse.”

According to Matluck, the current controversy concerning homeopathic products has more to do with efficacy than safety. “True homeopathic preparations contain such diluted amounts of the active ingredients that they shouldn’t pose a threat to the general adult population,” she says. “The efficacy remains unclear, though. My guess is that if the practitioner is highly skilled in homeopathic diagnosis and can consistently select the appropriate remedies, homeopathy is very effective. But very few clinicians in the West have that level of training and skill, so it’s not surprising that the efficacy of this practice is under question.”

Sanford believes the resurgence of homeopathic education in the US may have a profound impact on how these treatments are perceived and used in the future. “The Center for the Education Of Homeopathy (CEDH) has taken on the task of educating as many medical practitioners that hold some type of medical licensure as possible. This helps to ensure that trained personal prescribe and educate patients who are in need of this useful therapy.”

What should I do?

If you’re considering taking a homeopathic treatment, or any over-the-counter medication, consult with your primary care provider. Even though homeopathic treatments are largely believed to be safe when taken appropriately, the current lack of rigorous regulations make it difficult to determine the correct dosing. The best way to learn more about homeopathic remedies is to find a skilled and experienced practitioner who can prescribe appropriate treatments in the right doses. And remember that your provider can discuss the pros and cons of any treatment approach to help you arrive at an informed decision.

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The One Medical blog is published by One Medical, an innovative primary care practice with offices in Boston, Chicago, Los Angeles, New York, Phoenix, the San Francisco Bay Area, Seattle, and Washington, DC.

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