Regulatory Affairs

FDA proposes risk-based enforcement approach to homeopathic drugs

PBR Staff Writer Published 19 December 2017

The US Food and Drug Administration (FDA) is proposing new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs.

Published in draft guidance, the enforcement priorities are expected to keep a check on certain homeopathic drugs that can be harmful and have no proven medical benefits.

The drug regulator alleges that it continues to come across homeopathic drugs that are manufactured with active ingredients that can potentially create health risks.

In order, to protect consumers who prefer homeopathic products, the FDA would update its existing policy using the newly proposed approach.

The move will allow the regulator to help in dealing with situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not provided any clinical benefits.

The new enforcement priorities will also be used to address situations where products containing potentially harmful ingredients are passed off under the homeopathic label. Also, homeopathic products that do not comply with current good manufacturing practices will be targeted under the new approach from FDA.

FDA commissioner Scott Gottlieb said: “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The FDA revealed that some of the products that could come under the enforcement priorities in the draft guidance are infant and children’s products that contain belladonna and nux vomica and other ingredients known to have potentially significant safety concerns.

Additionally, homeopathic products that are sold for serious indications like cancer and heart disease have also been marked by the FDA to be subject to its enforcement priorities.


Image: FDA Building 51 in Silver Spring, Maryland which houses the Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.