Welcome to the CDER Small Business and Industry Assistance (SBIA) Podcast Series! Today’s topic: A New Era for Homeopathic Drug Product Regulation

On December 18, 2017, the U.S. Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. FDA re-examined its enforcement approach because the homeopathic drug industry has grown and there is a need to better address homeopathic treatments that are being marketed for serious diseases and/or conditions, but have not been shown to offer clinical benefits. The risk-based approach also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

Homeopathy is an alternative medical practice developed in the late 1700s. It’s based on the principle that a substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses, a concept known as “like-cures-like.”

Over the last decade, the homeopathic drug market has grown exponentially, resulting in a nearly 3-billion-dollar-industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims. FDA Commissioner Scott Gottlieb recently stated that, “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’s proposed new approach prioritizes enforcement and regulatory actions involving unapproved drug products labeled as homeopathic that pose the greatest risks to patients. As described in the draft guidance “Drug Products Labeled as Homeopathic,” FDA intends to focus its enforcement authorities on products including:

• Products with reported safety concerns
• Products that contain or purport to contain ingredients associated with potentially significant safety concerns;
• Products for routes of administration other than oral and topical;
• Products for vulnerable populations such as those with compromised immune systems, infants and children, the elderly, and pregnant women;
• Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
• And products deemed adulterated under section 501 of the Federal Food, Drug and Cosmetic Act.

FDA recognizes that many homeopathic products will fall outside these categories, but as stated by CDER Director Dr. Janet Woodcock, “The draft guidance is an important step forward in the agency’s work to protect patients from unproven and potentially dangerous products.”

Moreover, the risk-based enforcement approach is consistent with the agency’s mission to protect public health.

Under the Federal Food Drug & Cosmetic Act, homeopathic drug products are subject to new drug requirements related to approval, adulteration, and misbranding. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval since 1988 under the enforcement policies in FDA’s Compliance Policy Guide 400.400. 

Recently, FDA determined that it is in the best interest of public health to issue a draft guidance. The guidance proposes the risk-based enforcement approach to drug products labeled as homeopathic, which is consistent with FDA's risk-based regulatory approaches generally.

There are no homeopathic drug products marketed in the United States that are FDA-approved. This means that FDA has not evaluated them for safety or effectiveness. Thus, such products may not meet modern standards for safety, effectiveness, or quality. They may also cause harm to consumers who forgo treatment for serious conditions with medical products that have been scientifically proven to be safe and effective. People sometimes assume that homeopathic remedies are unlikely to cause harm because they are marketed as “natural.”

However, as with all drug products, the safety of homeopathic drugs depends upon many factors, including the manufacturing quality, and the identity and amount of “active” ingredient. Homeopathic products are often found next to over the counter products, and may not be labeled as homeopathic, so consumers may not realize that they have not been evaluated by FDA for safety or effectiveness.

Although homeopathic drug products are generally labeled as highly diluted, some products have been found to contain measurable amounts of active ingredients, and therefore could cause significant patient harm. FDA has also tested products that were improperly manufactured, which can cause incorrect dilutions and increase the potential for contamination.

And finally, some products labeled homeopathic are marketed to treat serious diseases or conditions and bring little to no benefit, and even irreparable harm. For more information, please read the complete draft guidance and submit comments via www.regulations.gov.

A link to the full SBIA Chronicle article and more information about CDER’s SBIA Program may be found at www.fda.gov/cdersbia. Thanks for tuning in.