Homeopathy drugs under FDA scanner

Makers may have to prove the safety and effectiveness of their products before selling them

Homeopathic treatments could receive greater scrutiny from the US Food and Drug Administration in the near future, as their growing popularity has led some critics to call for tighter regulation.

The FDA on Tuesday wrapped up two days of public hearings on homeopathic treatments, in which the agency took testimony on whether it should regulate the natural remedies the way it does over-the-counter drugs.

If it does, the makers of homeopathic medicines would have to demonstrate the safety and effectiveness of their products before they could be sold in drug stores and natural food shops. The FDA would also review each products’ labeling, to weed out false or misleading claims.

The agency last reviewed its regulation of homeopathic products in 1988, when it issued a policy guide that allowed the natural remedies to be placed on shelves without any pre-market approval, said Cynthia Schnedar, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.

“The market has grown tremendously in that time,” Schnedar said. “It was a multi-million dollar industry at the time, and now it’s a multi-billion dollar industry. In addition, we’ve seen some emerging safety concerns with the products. Because of the passage of time, the growth of the industry and emerging safety concerns, we thought it was time to take another look.”

The agency has issued nearly 40 warning letters since 2009 regarding the safety of various homeopathic products, Schnedar said. In 2009, the FDA issued a warning after receiving 130 reports of patients losing their sense of smell after using a Zicam product — a cold-fighting homeopathic nasal spray that contained zinc, she said.

A year later, the agency issued a recall for homeopathic Hyland’s Teething Tablets, a product that used belladonna as its active ingredient, she said. Babies had begun showing symptoms of belladonna poisoning, and labwork revealed that the tablets contained inconsistent amounts of the potentially deadly herb. And the FDA warned asthma sufferers earlier this year to avoid homeopathic products that promise to treat asthma symptoms. “These products have not been evaluated by the FDA for safety and effectiveness,” the agency said at the time.

Critics of homeopathic products argue that these remedies should endure the same sort of regulation as the over-the-counter drugs with which they share shelf space. They say there’s no evidence that homeopathic drugs actually work. On top of that, there are concerns that the medications may contain a mixture of ingredients that could prove dangerous to users.
“Not only do homeopathic remedies undergo none of the FDA review that conventional drugs are subjected to, but they are not regulated even to the degree that dietary supplements are,” Dr Adriane Fugh-Berman, an associate professor of pharmacology and physiology at Georgetown University Medical Center, testified at the hearings. “Disease claims are disallowed for dietary supplements, but homeopathic remedies can make the same disease treatment claims as conventional drugs.”

Homeopathy is an alternative medicine developed in Germany at the end of 18th century, according to the US National Center for Complementary and Integrative Health (NCCIH). Homeopathic remedies are derived from plants, minerals and animals. Examples include red onion, arnica, crushed whole bees, stinging nettle and belladonna. These ingredients are diluted and taken in many forms, including sugar pills, ointments, gels and creams, NCCIH says.

Homeopathy has become a big business in the United States. Adults spent almost $3 billion on homeopathic medicines in 2007, according to the NCCIH, with an estimated 4 million adults and 910,000 children relying on these natural remedies.

Many drugs labelled as homeopathic are marketed in major retail stores as natural, safe and effective alternatives to prescription and over-the-counter medications, according to the FDA. Science has found little evidence that homeopathy works, and its tenets run counter to basic science, critics contend.

“A number of the key concepts of homeopathy are not consistent with fundamental concepts of chemistry and physics,” the NCCIH says on its website. “For example, it is not possible to explain in scientific terms how a remedy containing little or no active ingredient can have any effect.” Despite this, the federal government has left the homeopathic drug market largely unregulated. When the FDA created its formal process to review over-the-counter drugs in 1972, the agency specifically excluded homeopathic medications, even though they fall under its jurisdiction.

“The FDA deferred review of drugs labeled as homeopathic due to the uniqueness of homeopathic medicine and stated that the FDA would review them as a separate category at a later time,” the agency said in its public hearing announcement. “To date, the FDA has not reviewed this class of products for safety and efficacy.” However, supporters of homeopathic medicine testified during the hearings that they see no reason to step up the regulation of these natural products now.

Appealing to physician and patient

The American Association of Naturopathic Physicians (AANP) “believes that the FDA’s current regulatory approach to homeopathic products is working well,” AANP board member and naturopathic physician Amy Rothenberg testified. “The low cost of these medicines, as well as the consistent quality of product, make them appealing to both physician and patient. Over decades of use, we have not found problems or variability with quality of the homeopathic product, and no toxicity has been reported,” she said.

But others testified that it’s time the FDA stepped into the fray. “We could spend hours discussing the extensive, decades-long scientific examination of homeopathy, but suffice to say the empirical evidence against homeopathy is overwhelming,” said Michael De Dora, director of public policy for the Center for Inquiry, an advocacy group that said it promotes reason and scientific integrity in public affairs. “Aside from a placebo effect, homeopathic products have no effect in treating illnesses.”

There’s also some concern that homeopathic drugs may not be as safe as touted, Fugh-Berman said. Because homeopaths believe that “less is more,” which means that a low-dose homeopathic remedy actually contains a greater amount of the active ingredient, she testified.

For example, the homeopathic cold remedy called Cold-Eeze contains 13.3 milligrams of zinc per lozenge, Fugh-Berman said. “At the recommended six lozenges a day, that’s about 80 mg of zinc daily, or 10 times the recommended daily allowance for adult females and eight times the recommended daily allowance for males,” she said, noting that excessive zinc intake can cause toxic effects.
Taking too much zinc might cause fever, coughing, stomach pain and fatigue, according to the US National Institutes of Health. And too much zinc taken over a long period of time may also double the risk of prostate cancer.

The FDA will accept written or e-mailed comments on homeopathic medicines until June 22. Beyond that, the agency has no timeline for the completion of its review, Schnedar said.