The US Food and Drug Administration (FDA) has announced its intention to introduce a new “risk-based enforcement approach” to protect consumers from unproven homeopathic products that could be potentially harmful to their health. 

According to the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research at the FDA, homeopathy is an alternative medical practice based on two main principles: that a substance causing symptoms in a healthy person can be used in diluted doses to treat other symptoms and illnesses; and that the more diluted the substance, the more potent it is, also known as the “law of infinitesimals”.  Homeopathic medications may be available over-the-counter or as prescription drugs. 

There are no FDA-approved products labeled as homeopathic, which means any product marketed this way in the United States has not been evaluated for safety and effectiveness by the agency. In the past, the FDA has issued a number of warnings about potentially dangerous homeopathic products, including homeopathic teething kits containing belladonna and homeopathic asthma products sold over-the-counter. 

In a recent press release, the FDA stated some prescription and nonprescription drugs labeled as homeopathic treatments have been manufactured and distributed in the United States without approval from the agency. Consequently, it is introducing a new approach to enforcement, particularly targeting products marketed as treatments for serious diseases or conditions, those which contain potentially harmful ingredients, or where manufacturing practices do not meet the necessary 

Janet Woodcock, MD, director of the CDER, asserted: “Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness, and quality.” She described the new agency guidance as an “important step forward” in its efforts to provide further protection for patients. 

“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,” said FDA Commissioner Scott Gottlieb, MD. He observed a significant upsurge in interest and availability of homeopathic medicines in recent years, ranging from common cold treatments to cancer therapies. However, these therapies bring “little or no benefit” to patients, and could cause “irreparable harm” when active ingredients are properly tested and disclosed to patients, he warned. 

The new FDA approach will target products with safety concerns, those containing ingredients with potentially significant safety concerns, products with a route of administration other than oral or topical, those for serious or life-threatening ailments, products for vulnerable populations, and medications that do not meet current legal standards of quality, strength or purity. 

In November 2016, the Federal Trade Commission announced a new “Enforcement Policy Statement on Marketing Claims for Over-the-Counter Homeopathic Drugs”, with the expressed aim of looking into how homeopathic products are marketed to consumers. It observed many homeopathic products available over-the-counter do not have a scientific claim to efficacy, but rather that they are based on theories of homeopathy that may be outdated or unproven.