Apr 21, 2015

Homeopathic Products Under FDA Scrutiny

The Food and Drug Administration is re-examining its position on whether it should regulate homeopathic products, which are often sold alongside (and may be confused with) proven medications with active ingredients in pharmacies across the country.

In 1988 the FDA decided not to require that homeopathic remedies go through the same drug-approval process as standard medicines. Hearings began Monday in Washington and should the FDA decide that homeopathic products fall under its purview, manufacturers would need to prove that their products are safe and effective.

Homeopathy has been extensively studied, and researchers have concluded that it does not work.

In 2010 the British Science and Technology Select Committee conducted an examination of whether homeopathy has any medical or scientific validity; its report concluded that “there is no evidence that homeopathy works beyond the placebo effect (where a patient gets better because of their belief in the treatment).”

Australia’s National Health and Medical Research Council also investigated the effectiveness of homeopathy in a report released last month. It, too, reached the same damning conclusion: “there are no health conditions for which there is reliable evidence that homeopathy is effective.”

According to an article in the “Washington Post” while homeopathy advocates defend their practice, some welcome the proposed FDA oversight. “Ronald Whitmont, a homeopathic doctor in New York and president of the American Institute of Homeopathy, said his organization supports the FDA’s actions to crack down on poor manufacturing practices. ‘There are always bad apples in the manufacturing world, and they need to be policed just like in any other industry,’ he said. ‘We are behind the FDA. Their concern is our concern.’”

Whitmont added that he hoped that the FDA would not end up questioning the legitimacy of homeopathy’s practices or principles. One homeopathic practitioner even claimed in 2012 that homeopathic products could be used to somehow treat and prevent domestic violence.

Earlier this month the Canadian government took similar steps toward regulating homeopathy in the province of Ontario. A new law, the Ontario Homeopathy Act, provides a mechanism for homeopaths to self-regulate in a similar manner to doctors and nurses. Critics of the law, however, expressed concern that the effect would be to legitimize “the health-care equivalent of dowsing rods.”

Among those who testified in favor of the FDA revising its position was Michael De Dora, Director of Public Policy for the Center for Inquiry, a non-profit educational organization dedicated to evidence-based public policy. “I think the FDA is finally revisiting the issue of regulating homeopathy because of several troubling and prominent cases related to homeopathy,” De Dora told Discovery News. “In 2010, there was a situation in which homeopathic products for teething children containing too much belladonna put several kids in the hospital.

More recently, homeopaths have been claiming to own cures for everything from asthma to more pressing public health issues, such as Ebola which has prompted to FDA to write letters and issue consumer warnings.

Still, perhaps the greatest harm caused by homeopathy is not necessarily caused by the products themselves—which, when properly prepared, rarely contain anything other than water and inactive ingredients such as sugars and binding agents—but by the fact that people often rely on homeopathic products to the exclusion of proven scientific remedies.”

Following his testimony De Dora said he was “encouraged by the critical questions the FDA panel posed. The FDA would have never held this hearing if they didn’t have some inclination to regulate homeopathy.

Read more at Discovery News

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