U.S. to crack down on "potentially harmful, unproven" homeopathic drugs

WASHINGTON, Dec. 18 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Monday proposed a tougher enforcement approach toward homeopathic drugs, saying it would crack down on products that have the greatest potential to cause risk to patients.

Homeopathy is an alternative medical practice developed in the late 1700s, based on two main principles: that a substance that causes symptoms in a healthy person can be used in diluted form to treat illness and that the more diluted the substance, the more potent it is.

Under U.S. law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.

Over the last decade, the once-small homeopathic drug market has grown exponentially, resulting in a nearly three-billion-U.S.-dollar industry that "exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims," the FDA said.

"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse -- that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," FDA Commissioner Scott Gottlieb said in a statement.

"Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."

The FDA said it intends to focus its enforcement authorities on the highest-risk products, including those that have reported safety concerns, contain or claim to contain ingredients associated with potentially significant safety concerns, are administered by injection, or are intended to be used for the prevention or treatment of serious or life-threatening diseases and conditions.

Examples of products that may be subject to the enforcement priorities in the draft guidance are infant and children's products labeled to contain ingredients associated with potentially significant safety concerns, such as belladonna and nux vomica; and products marketed for serious conditions, such as cancer and heart disease, the agency said.

However, many homeopathic products will likely fall outside the risk-based categories described in the new draft guidance and will remain available to consumers, it added.

The proposed approach, which will now be open for public comments for 90 days, came after more than one year after homeopathic teething tablets and gels containing belladonna, a toxic substance that has an unpredictable response in children under two years of age, were linked to 10 deaths and more than 400 adverse reactions in children.

An FDA lab analysis later confirmed that certain homeopathic teething tablets contained elevated and inconsistent levels of a toxic substance called belladonna.

Over the past several years, the FDA has also issued a number of warnings related to other homeopathic drug products, including certain zinc-containing intranasal products that may cause a loss of sense of smell, homeopathic asthma products that have not been shown to be effective in treating asthma and other products labeled to contain potentially toxic ingredients, like nux vomica, which contains strychnine, a highly toxic poison often used to kill rodents. Enditem