The FDA Takes a New Look at Homeopathic Drugs
Should products like Cold-Eeze and Zicam be regulated like other drugs?
As the market for homeopathic drugs like Cold-Eeze and Zicam has grown into the billions of dollars, the U.S. Food and Drug Administration (FDA) is seeking input on whether they should be regulated.
The FDA is holding a public hearing on Monday and Tuesday this week at its Silver Spring, Md., campus.
Homeopathic drugs are subject to regulation under federal law, but the FDA has deferred review of those drugs since 1972, saying it would weigh in “at a later time,” according to a proposed rule published March 27 in the Federal Register.
It never has. “To date, FDA has not reviewed this class of products for safety and efficacy,” the proposed rule said.
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Speakers Pro and Con
Scheduled to speak at the hearing were representatives of a number of homeopathic medicine groups and manufacturers, including the Homeopathic Academy of Naturopathic Physicians, the National Center for Homeopathy and Holistic Moms Network.
The supporters of homeopathy vastly outnumbered those presenting a cautionary view. Among the latter was Dr. Adriane Fugh-Berman, of Georgetown University Medical Center. “I am concerned about the current state of labeling for homeopathic remedies, particularly OTC (over the counter) preparations,” Fugh-Berman wrote in testimony submitted in advance of the hearing. “Allowing homeopathic remedies to sit side-by-side with conventional drugs that have undergone FDA scrutiny as over-the-counter drugs is inherently misleading.”
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She said homeopathic remedies “can include arsenic, snake venom, heavy metals, controlled substances and other ingredients that would be considered potentially unsafe by usual drug standards.”
Poison Concerns
As with other drugs, homeopathic drugs can cause side effects, drug interactions and adverse effects, the FDA said. The 2012 American Association of Poison control Center Annual Report cited 10,311 “poison exposure” cases — 8,788 of those experienced by children age five and under.
But supporters praised their safety, effectiveness and low cost.
The current FDA policy is “sufficient as written,” Amy Rothenberg, N.D. (naturopathic doctor), wrote in prepared remarks. “Since they are extensively trained in pharmacology, NDs are able to integrate naturopathic treatments with prescription medications, often working with conventional medical doctors and osteopathic doctors, as well as compounding pharmacists, to ensure safe and comprehensive care.
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“Over decades of use, we have not found problems or variability with quality of the homeopathic product, and no toxicity has been reported,” Rothenberg wrote.
Endorsements from Consumers
One writer commented on the FDA website that she has worked with a homeopathic doctor for years. “I am always satisfied and always have positive results,” the commenter wrote. “I feel strongly that the FDA should not change the current regulations. Please don't try to fix what isn't broken.”
Homeopathic drugs have grown from a multimillion dollar industry as of 1988, the FDA estimated, to one that consumers spent $2.9 billion on as of 2007, according to the National Health Interview Survey, conducted by the Centers for Disease Control and Prevention’s National Center for Health Statistics.
Many of the drugs are sold over the counter in major retail stores and marketed as alternatives to both prescription and nonprescription remedies.
The FDA is accepting written or electronic public comment on the issue until June 22.
