Homeopathy: Health Thyself, says FDA. We’re Not The Problem, say Practitioners.

Homeopathy is an alternative medical practice developed centuries ago that contends substances that effectively cause illness symptoms in otherwise healthy people can actually be used in diluted form to treat illness. And the more diluted it is, the more potent it may be.

That’s the view of the U.S. Food and Drug Administration, which is now at loggerheads with the $3 billion homeopathic industry and is trying to impose regulations on it.  The homeopathic industry has opposed the FDA plans.

The FDA has proposed boosting enforcement of the manufacturing, marketing and safety regulations of homeopathic products, which have been produced since the 1800s.  Homeopathic drug products are prepared from a variety of sources, including plants, minerals, chemicals and human and animal excretions or secretions. They are sold in pharmacies, retail stores and online.

Homeopath professionals see the body as a holistic system working to heal itself. The medications used work to stimulate the healing process, its proponents say.

That is opposed to naturopathy, often in Chinese medicine, in which practitioners work to discover the root causes of illnesses and eliminate them through elements such as supplements and food to balance the body.

Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product, the FDA says. But prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without agency approval since 1988.

Essentially, FDA officials say they are concerned that homeopathic treatments are being marketed for serious disease and conditions, but products may not have shown clinical benefits. Some products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices, and there have been adverse events and death as a result, the FDA says.

Several yards ago, the FDA warned against the use of homeopathic teething devices containing belladonna, a toxic substance associated with serious adverse events, including seizures and deaths in infants and children.

“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases an conditions, from the common cold to cancer,” said FDA Commissioner Scott Gottlieb, MD. “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.”

Homeopathy officials have spoken out against the FDA plans, with many saying the government should bring together an expert advisory council to examine the issue.

“Homeopathy is beneficial, safe and cost-effective,” wrote Ronald W. Dushkin, MD, the President of the American Institute of Homeopathy, in a comment about the FDA plans. “Integrating it more broadly into the U.S. healthcare system will contribute generously toward the resolution of many pressing social and public health crises affecting our society.”

“If the FDA’s intent is to fully reevaluate its approach to the regulation of homeopathic drugs, then a rush to declare all of them illegal (i.e., unapproved new drugs) is immensely counterproductive,” he added.

Other homeopathy officials, including Paola Brown, President of the Americans for Homeopathy Choice, submitted a petition to the FDA saying that the agency should establish an expert advisory committee on homeopathy. — Joe Cantlupe. (This was part of a piece I wrote for

HCPnow

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