The US Food & Drug Administration (FDA) could soon start regulating and possibly banning popular natural homeopathic remedies.
The agency is considering changes that would place the same restrictions and regulations on homeopathic substances that are placed on other drugs.
“At this stage we are gathering information about whether to adjust our current enforcement policy,” Cynthia Schnedar, the director of the FDA’s Center for Drug Evaluation and Research, told The Washington Post.
The FDA held hearings on the matter this week and is taking public comments, too.
Schnedar did not reveal what changes her agency is considering. Currently the FDA merely sends manufacturers of homeopathic products warning letters if its staff thinks they are dangerous or go too far in their claims. It has sent nearly 40 letters since 1989.
Homeopathy is an alternative medicine, defined by Merriam-Webster as “a system for treating illnesses that uses very small amounts of substances that would in larger amounts produce symptoms of the illnesses in healthy people.” Mainstream medicine mostly rejects homeopathy, even though many people believe in it. One of the more popular mainstream homeopathy products is Zicam, which is labeled as homeophatic, although some say Zicam is not homeopathy.
Could it be Banned?
Critics are concerned the FDA will go too far in its regulations, perhaps regulating ingredients that many consumers say actually work. Last month, the FDA warned consumers not to use homeopathic asthma treatments.
“The potential risk to consumers is if any change in regulation were to limit access to these products,” Mark Land, the president of the American Association of Homeopathic Pharmacists, told National Public Radio.
The FDA has had the power to ban or regulate homeopathic products like any other drug since 1938 under federal law, but the agency has never exercised that authority largely because of fears of a political backlash. In recent years, however, critics have been demanding it change the policy.
‘Purest Form of Pseudoscience’?
“Homeopathy is an excellent example of the purest form of pseudoscience,” Yale neurologist Steven Novella told NPR. Novella has been lobbying the FDA to regulate homeopathic remedies for years. “These are principles that are not based upon science.”
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The FDA has been more concerned about the quality, purity and safety of homeopathic remedies than the science involved, Schnedar told NPR.
“There’s no question that it helps patients,” Dr. Anthony Aurigemma, a homeopathic physician who practices in Bethesda, Maryland, told NPR. “I have too many files on too many patients that have shown improvements.”
Like many homeopaths, Aurigemma believes that some makers of homeopathic remedies make unrealistic or exaggerated claims about their products. Yet he defended his work.
Like many homeopathy advocates, Land believes such products are safe because they are highly diluted.
“Homeopathic medicines have a very long history of safety,” said Land, who is also vice president of operations and regulatory affairs for Boiron USA, a maker of homeopathic medicines. “One of the hallmarks of homeopathic medicines is safety.”
Essentially Banned in Britain
The FDA last reviewed its policy on homeopathic treatments in 1988 and decided to make no actions. Critics are afraid that health insurance will stop funding homeopathic treatments if the FDA takes a hardline positions against them. The fears are not unfounded; a similar decision has effectively throttled alternative medicine in the UK.
Two-thirds of insurers in the United Kingdom stopped funding homeopathy after the British equivalent of the FDA, the Medicines and Healthcare Regulatory Agency, ruled homeopathic cures were not medicines, the BBC reported.
British universities stopped teaching homeopathy and other forms of alternative medicine shortly after that decision was made, the German website Deutsche Welle reported. Just a few years prior, 45 British universities offered degrees in various kinds of alternative medicine.
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