U.S. FDA Proposes Risk-Based Approach for Homeopathic Drug Products

20/12/17

Event Title

08h00 - 16h30

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On December 18, 2017, the U.S. Food and Drug Administration (FDA) published the draft guidance, Drug Products Labeled as Homeopathic, outlining their enforcement and regulatory priorities for homeopathic drug products. Many products that are currently available will not be impacted by this draft guidance, as it is currently written, because the FDA is planning to take a risk-based approach to target homeopathic drug products that fall under the following categories:


• 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 such as injectable or ophthalmic products;

• Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;

• Products for vulnerable populations such as infants, the elderly, and pregnant women; and

• Products that do not meet standards of quality, strength or purity as required under the law


The FDA is accepting comments on the draft guidance for 90 days after publishing.


Background

Homeopathic drug products are based on the concept of “like-cures-like,” where a substance that causes symptoms in a healthy person can be diluted and used to treat a condition with the same symptoms, and the more dilute the substance, the more effective it will be. Homeopathic products were traditionally developed for individual patients and distributed by a practitioner, but recently they have grown in popularity and may be purchased over-the-counter. This increased popularity has resulted in an increase in safety concerns, which is why the FDA is revisiting their enforcement policies in this draft guidance. Since 1988, homeopathic drug products been manufactured and distributed without FDA approval based on the Compliance Policy Guide (CPG) 400.400 Conditions Under Which Homeopathic Drugs May be Marketed, but they have been subject to the same adulteration and misbranding requirements as other drug products. When this guidance is finalized the FDA plans to withdraw the CPG. 


Click to view draft guidance:

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm589373.pdf


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