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The FDA Considers Cracking Down On Untested Alternative Medicine Treatments

CREDIT: SHUTTERSTOCK
CREDIT: SHUTTERSTOCK

Amid an increasing number of Americans who are opting to rely on alternative medicine treatments, officials from the Food and Drug Administration (FDA) are revisiting the way that the agency regulates homeopathic products — which currently don’t have to be approved by regulators before they’re sold over the counter.

This week, the FDA is holding a two-day hearing on homeopathy, hoping to solicit feedback about whether these products need more regulatory oversight. “At this stage, we are gathering information about whether to adjust our current enforcement policy,” Cynthia Schnedar, the director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, told the Washington Post.

Homeopathy, a form of alternative medicine that dates back to an 18th century German doctor, is based on the premise that “like cures like.” Essentially, that theory suggests that diseases can be cured with heavily diluted dosages of a substance that causes similar symptoms. Homeopathic remedies have grown popular for common ailments like the cold and the flu, although some proponents also advocate homeopathy for more serious diseases like asthma, malaria, and even cancer.

On its website, the National Center for Homeopathy says that this approach is a “safe, gentle, and natural system of healing that works with your body to relieve symptoms, restore itself, and improve your overall health.” Critics, meanwhile, say there’s no evidence that homeopathic remedies work — one large study recently concluded that homeopathy is no better than a placebo — and warn that there are some cases in which they can actually be harmful. The FDA maintains that the agency is “not aware of scientific evidence to support homeopathy as effective.”

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In 1988, the FDA decided that homeopathic remedies should not be required to go through the same approval process as over-the-counter drugs like Tylenol do, which means that the agency does not test these products to ensure their safety or efficacy. More than two decades later, as the agency prepares to revisit the subject, hundreds of comments have poured in from people on both sides of the issue.

Supporters of homeopathic remedies are concerned that the FDA is going to overstep its bounds and restrict Americans’ ability to choose the alternative treatments that work best for them. Dr. Anthony Aurigemma, a homeopathic practitioner in Maryland, told NPR that “it would be a terrible loss to this country if they were to do something drastic,” adding that he has “too many files on too many patients that have shown improvements.”

But opponents say that it’s long past time for the agency to crack down on this brand of pseudoscience, particularly since the FDA has issued nearly 40 warning letters over the past several years to companies making misleading claims about the efficacy of their homeopathic products. In 2009, for instance, the FDA told Americans to avoid a certain homeopathic cold remedy after receiving reports from more than 130 people who said they lost their sense of smell after using the treatment.

Some homeopathic doctors, like Ronald Whitmont, are striking somewhat of a balance between those two stances.

Whitmont, who serves as the president of the American Institute of Homeopathy, told the Washington Post that he hopes this week’s FDA hearing doesn’t turn into a larger debate about the efficacy of homeopathy, which he believes has been proven to work. But he also said that his organization supports government officials’ attempt to safeguard consumers from products that are being deceptively advertised. “There are always bad apples in the manufacturing world, and they need to be policed just like in any other industry,” Witmont said. “We are behind the FDA. Their concern is our concern.”

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Even aside from homeopathic remedies specifically, there has recently been a larger debate about potentially harmful products being sold on pharmacy shelves. Dietary supplements — which are one of the most popular natural health remedies among Americans, even though many of their purported benefits aren’t backed up by scientific evidence — have come under increased scrutiny amid evidence that these products are often mislabeled.

Like homeopathic remedies, popular dietary supplements are largely outside of the purview of the FDA. Supplements are currently regulated like food, rather than like drugs. Earlier this month, 14 state attorneys general wrote a letter to Congress pressuring lawmakers to launch an investigation into the supplements industry, noting that Americans need “full information about a product they are ingesting.”