The U.S. Food and Drug Administration in December issued a proposal for a new risk-based enforcement approach to drug products labeled as homeopathic. According to the agency, the proposed change would update existing policies on quality control in the manufacturing and marketing of homeopathic products that the FDA found lacking in clinical benefits.
The homeopathic drug market grew over the past decade into a $3 billion industry “that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims,” FDA officials said in the announcement.
The agency claimed that homeopathic teething tablets and gels containing belladonna “were associated with serious adverse events, including seizures and deaths, in infants and children.” In 2010, it noted, products sold under the Hyland’s Teething Tablets brand were found to contain varying amounts of belladonna, the deadly nightshade plant that can be toxic for humans. The FDA also pointed to “certain homeopathic zinc-containing intranasal products that may cause a loss of sense of smell.”
“Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The draft guidance is an important step forward in the agency’s work to protect patients from unproven and potentially dangerous products.”
In this region, the FDA’s actions were received with confusion and anger by some homeopathic practitioners.
“That is a very loose statement and I’m not even sure what it says,” said Dr. Ronald D. Whitmont, a homeopathic physician in Rhinebeck and president of the American Institute of Homeopathy. “It is a series of sentences that says they’re monitoring harmful remedies, but the words can be interpreted subjectively.”
Homeopathy is an alternative medicine practice developed in the late 18th century by German physician Samuel Hahnemann, who theorized that a natural substance that can create symptoms of illness in a healthy person can be used in a severely diluted form to treat a sick person. Hahnemann also believed that the substance’s potency increased with greater dilution levels, ultimately helping to enhance the body’s normal healing and self-regulatory processes. Most homeopathic remedies derive from plant or mineral sources.
Homeopathy was introduced to the U.S. in 1825, but the practice is more prevalent in Europe. The National Institutes of Health estimates that more than 6 million people in this country use homeopathy, primarily in self-administered care to treat specific conditions. The Homeopathic Research Institute estimates that roughly 29 percent of the population in the European Union’s member nations use homeopathic medicines in their day-to-day health care.
Medical doctors can practice homeopathy anywhere in the U.S., while Connecticut is one of three states, along with Arizona and Nevada, with homeopathic medical boards that license medical doctors who specialize in homeopathy.
Among practitioners of conventional medicine, many believe that homeopathic remedies have no more curative value than a placebo. But Dominick Masiello, a physician offering homeopathic and osteopathic care in Manhattan and Ridgefield, disagreed with that commonly held view.
“Critics of homeopathy want it both ways,” he said. “They say there is nothing in it and that it’s a total scam, but then they say that someone got poisoned by it.”
Masiello also faulted the FDA for citing a quality control problem at a single facility as being representative of the entire industry. “They are talking about one company, one manufacturing plant. Someone put too much belladonna in a teething product. That company has been around for 90 years,” he said.
Masiello said he was not previously aware of the FDA’s claims about seizures and deaths related to teething products. Whitmont pointed out that no medical evidence, has ever been presented that specifically tied any infant death exclusively to a homeopathic product and no criminal charges have
Whitmont also faulted the FDA for holding up the Zicam nasal spray product as an example of homeopathy gone haywire. “That is not a homeopathic medicine,” he said. “It is a combined medicine with a high level of zinc, and zinc is known to cause problems in nasal use.”
Susan Sonz, director of the New York School of Homeopathy in lower Manhattan, was surprised at the FDA’s report of a $3 billion homeopathic industry. “Three billion dollars?” she said with a laugh. “I find that hard to believe. Any homeopath will tell you that is highly improbable. It is not that big in this country. Homeopathic remedies are cheap, $8 over the counter.”
Sonz also questioned the FDA’s statement that it has not approved homeopathic drugs for any use.
“Very, very early in the FDA’s life, homeopathy got approved as safe and over-the-counter,” she said, pointing to the federal Food, Drug, and Cosmetic Act of 1938. “Now, suddenly, they say it’s not safe? To say homeopathy kills is playing into the current political climate of saying whatever you want to get whatever you want.”
What impact the FDA’s course of action will have on the sale of homeopathic remedies is unclear.
Masiello predicted that it would have no impact unless buyers for chain drug stores decided to remove homeopathic products from their shelves. Homeopathic practitioners have other more pressing concerns, he said, such as expanding their inclusion in health care network coverage by insurers.
Dr. Randy Trowbridge, founder of Team Rehab in Danbury and president of the Fairfield County Medical Association, also expressed skepticism about the tone of the FDA’s new attention to homeopathy. A less heavy-handed approach would be more appropriate in addressing regulatory concerns, he said.
“Sometimes there are natural remedies that can be harmful if not used properly,” Trowbridge said. “It is necessary to alert people that anything in excess is harmful to the human body.”
Darin Ingels, a naturopathic practitioner in Fairfield, wondered about the FDA’s lack of outrage over some traditional over-the-counter drugs. “Aspirin kills 3,000 people per year,” he said. “Where was everyone clamoring to take aspirin off the shelf?”