The FDA is proposing a new risk-based enforcement approach to homeopathic drug products. Among the targets: products marketed for serious diseases without showing clinical benefits, products that contain potentially harmful ingredients, and products that don’t meet current good manufacturing practices.
Under the 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.
“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,” said FDA Commissioner Scott Gottlieb, MD. “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.
“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,” he added.
The FDA’s proposed approach prioritizes enforcement and regulatory actions involving unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients. Under this approach, many homeopathic products will likely fall outside the risk-based categories described in the new draft guidance and will remain available to consumers. The FDA intends to focus its enforcement authorities on the following kinds of products:
- Products with reported safety concerns
- Products that contain or claim to contain ingredients associated with potentially significant safety concerns
- Products for routes of administration other than oral and topical
- Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions
- Products for vulnerable populations
- Products that do not meet standards of quality, strength, or purity as required under the law
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.
While the FDA considers comments to the draft guidance, the FDA intends to examine how the agency is implementing its current compliance policy. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA will consider taking additional enforcement and/or regulatory actions, consistent with the current enforcement policies, which also align with the risk-based categories described in the draft guidance, in the interest of protecting the public.
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 (known as “like-cures-like”); and the more diluted the substance, the more potent it is (known as the “law of infinitesimals”). Homeopathic drug products are prepared from a variety of sources, including plants, minerals, chemicals and human and animal excretions or secretions. These products are typically sold in pharmacies, retail stores, and online.
Until relatively recently, homeopathy was a small market for specialized products. Over the last decade, the homeopathic drug market has grown exponentially, resulting in a nearly $3 billion industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims. During this time, the FDA has seen a corresponding increase in safety concerns, including serious adverse events, associated with drug products labeled as homeopathic. In addition, the agency has also found an increasing number of poorly manufactured products that contain potentially dangerous amounts of active ingredients that can create additional risks.
Source: FDA; December 18, 2017.