The FDA Might Finally Crack Down on Homeopathy
On a recent afternoon in midtown Manhattan, I popped into a chain drug store and picked up some $12 sleep tablets whose label promises both “courage and peace of mind” and “focus when ungrounded.” I also got a $17 tube of cream offering “rapid, soothing relief of pain” from conditions as varied as arthritis, carpal tunnel syndrome, and bug bites. Both products sat on shelves alongside familiar drugs such as Tylenol and Claritin, which regulators have carefully scrutinized for safety and effectiveness. The half- dozen products I bought—labelled as "homeopathic"—aren't vetted for either.
Royal Copeland, a New York senator and homeopath, got the treatments treated as drugs in a 1938 law.
Source: Library of Congress
Homeopathic remedies are based on an idea, developed at the end of the 1700s, positing that the substances responsible for medical problems, when delivered in highly diluted doses, can cure diseases instead. Since then, homeopathy has had staying power. In 1938, a U.S. senator (and homeopath) named Royal Copeland bolstered the practice by passing a law classifying homeopathic treatments as drugs. And in the 1970s, a wave of interest in New Age and alternative medicine again brought homeopathy to the fore. Scientists now agree—overwhelmingly—that the remedies don't work. But each year, billions of dollars worth of homeopathic products are sold in the U.S.
Historically, regulators have generally looked the other way. That stance may be poised to change: The Food and Drug Administration (FDA) is this week holding a public meeting to evaluate "whether and how to adjust the current enforcement policies" to keep up with the growing homeopathic industry and a corresponding increase in safety problems. Since 2009, the FDA has sent nearly 40 warning notices to homeopathic manufacturers and has overseen three recalls. Pulled products include zinc cold remedies that caused people to lose their sense of smell and "teething tablets" with toxic levels of the plant belladonna.
About 3.3 million Americans spent $2.9 billion on homeopathic treatments in 2007, according to the latest estimates from the Centers for Disease Control (CDC), though private industry research suggests a smaller market. The industry has "mushroomed" since the early 1980s, when homeopathic sales were just $1.5 million a year, says Bill Nychis, who worked at the FDA for 39 years in compliance and enforcement. At the time, the agency was midway through a decades-long process reviewing older over-the-counter drugs for safety and efficacy. The FDA had the authority to regulate homeopathic remedies, but because sales were so small, the agency opted to outsource much of that job to the industry itself. "Risk is always depending upon the number of products on the market and the sales volume of the products," says Nychis, who now advises importers at FDAImports.com.
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http://www.bloomberg.com/news/articles/2015-04-20/the-fda-might-finally-crack-down-on-homeopathy
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