The FDA Might Finally Crack Down on Homeopathy

Remedies debunked by science make up a multibillion dollar market in the U.S.

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.
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.

In 1988, the FDA issued a policy guide "where we basically allow these drugs to come to the market without premarket approval,” says Cynthia Schnedar, director of compliance for the agency’s Center for Drug Evaluation and Research. Federal regulators allow the sale of any substance listed in the Homeopathic Pharmacopeia, a document published since the 1800s and maintained by a nonprofit industry association. The remedies need to meet certain FDA manufacturing guidelines and can be marketed over the counter only for “self-limiting” conditions, meaning illnesses like colds that go away on their own.

Schnedar acknowledges it’s time for the FDA to reevaluate that policy. “We’ve seen a huge expansion of the market and we’ve also seen some emerging safety and quality issues,” she says. A panel of nine FDA officials, including lawyers, a pediatric ethicist, and the director of the over-the-counter drugs division, will hear "from people on all sides of this question," Schnedar says. She wouldn’t elaborate on changes the FDA is considering, but in its notice about the sessions, the agency said it would seek data about the risks and benefits of homeopathic products, recommendations on regulatory processes, and would look into whether consumers "have adequate information to make informed decisions" about such remedies.

Critics of homeopathy say FDA action is overdue. Stephen Barrett, a retired North Carolina psychiatrist who operates the fraud-busting site Quackwatch, petitioned the agency in 1994 to require that homeopathic remedies meet the same standards for safety and effectiveness as other drugs. The agency has cracked down on claims that homeopathic products can treat cancer or substitute for flu vaccines, but Barrett says it hasn’t done enough to warn consumers about common over-the-counter remedies. "You can’t separate safety from effectiveness,” he says. "If it’s not effective, it’s not safe."

Manufacturers of homeopathic products argue that the consumer should be the judge. "Millions of Americans use homeopathic medicines and want access to them," says John P. Borneman, chief executive of Hyland’s Homeopathic and president of the industry association that publishes the Homeopathic Pharmacopeia. "These medicines are very effective, people like using them, [and] it’s part of consumer choice in the United States."

Authorities worldwide disagree with Borneman's claims that homeopathy is effective. A recent evaluation of scientific evidence by the Australian government concluded that "that there are no health conditions for which there is reliable evidence that homeopathy is effective.” A U.K. government review five years ago reached a similar conclusion, and the U.S. National Institutes of Health says there’s little evidence to support the practice, and notes that “several key concepts of homeopathy are inconsistent with fundamental concepts of chemistry and physics."

In the U.S., homeopathic remedies have become more common at national pharmacy chains, says Yale historian Naomi Rogers, who has studied the history of medicine and homeopathy. "Homeopathic drugs didn’t disappear, but they moved from prescription drugs to all over-the-counter drugs," she says. "They start to be seen as—or even packaged as—the equivalent of special vitamins, special kinds of extra things you can take to stay healthy, or to get healthy, or to treat something that you have that you don’t want to go to a doctor for."

At this week's hearing, the FDA will consider whether its current approach is "appropriate to protect and promote public health in light of the tremendous growth of the homeopathic market." Barrett says the answer is no, and he suggested a way 20 years ago to deal with it: "Hold homeopathic drugs to the same standards as other drugs." Which would probably make them harder to find at your local pharmacy.

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