The FDA Is Cracking Down on Risky Homeopathic Drugs

Many patients with cancer choose to use homeopathic therapies either in addition to, or in lieu of traditional treatments. However, since these agents don’t go through the same FDA approval process as typical drugs, patients may be subject to harmful effects.

To protect consumers who choose to use homeopathic drugs, the FDA recently proposed a set of risk-based enforcement priorities.

“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,” said FDA Commissioner Scott Gottlieb, M.D., in a statement.

Homeopathy was first developed in the late 1700s, and is an alternative medicine practice where drugs are typically derived from sources such as plants, minerals, chemicals and human and animal excretions and secretions. Over the last decade, the market for homeopathic agents has been booming and is now a nearly $3 billion industry — sparking some safety concerns from regulatory bodies like the FDA.

“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,” Gottlieb said.

The proposed approach will specifically target unapproved products that are labeled as homeopathic and have the greatest potential to cause risk to patients. This will likely keep many products that don’t fall into this category on the market.

FDA enforcement authorities will focus on: products with reported safety concerns; products that contain or claim to contain ingredients that are associated with potentially significant safety concerns; products administered in ways other than orally and topically; products intended to prevent or treat serious or life-threatening diseases and conditions; products for vulnerable populations; products that do not meet standard of quality, strength or purity as required under the law.

Products that claim to treat or cure cancer fall under this list. Given the rising safety concerns surrounding homeopathic medicine — especially as the industry continues to grow in the United States — the FDA may consider additional enforcement and/or regulatory actions that are consistent with the current enforcement policies.

“Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, efficacy and quality,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a statement. “The draft guidance is an important step forward in the agency’s work to protect patients from unproven and potentially dangerous products.”