FDA Guidance on Homeopathic Drugs: An Ongoing Public Health Failure

In December 2022, the Food and Drug Administration (FDA) issued new guidance on homeopathic drugs.[1] The guidance states that the agency now “intends to apply a risk-based enforcement approach to the manufacturing, distribution and marketing of homeopathic drug products.”

Under this new risk-based approach, the agency plans to target its enforcement actions against homeopathic drug products marketed without FDA approval that fall within the following limited categories:

• products with reports of injury that, after evaluation, raise potential safety concerns
• products containing ingredients associated with potentially significant safety concerns
• products that are not administered orally or topically
• products intended to be used to prevent or treat serious or life-threatening diseases
• products for vulnerable populations, such as infants and the elderly
• products with significant quality issues

But this new FDA guidance fails to adequately address the public health threat posed by the agency’s decades-long permissive approach to these illegal drug products.

Under FDA regulations, prescription and over-the-counter (OTC) homeopathic products are considered drugs and are supposed to be subject to the same review and approval requirements as all other prescription and OTC medications.[2] However, under a flawed enforcement policy issued in 1988, the FDA has allowed these drug products to be marketed in the U.S. without agency review or approval. Thus, all products labeled as homeopathic are being marketed without the FDA having evaluated their safety, effectiveness or quality.

The term “homeopathy” is derived from the Greek words “homeo,” meaning similar, and “pathos,” meaning suffering or disease.[3] A German physician named Samuel Hahnemann introduced homeopathy in the late 1700s.[4] Hahnemann formulated the “Law of Similars,” which theorizes that “like cures like.” This law asserts that a substance that produces a set of symptoms in a healthy person has the ability to cure an ill person who has those same symptoms if the substance is administered in very low doses. The administration of a homeopathic remedy purportedly causes the body to react to the worsening of symptoms induced by the remedy, thus promoting a cure.

However, there is no plausible physiologic or medical basis to support the theory underlying homeopathy, nor is there evidence from well-designed, rigorous clinical trials showing that homeopathic drugs are safe and effective.

The FDA should declare unequivocally that all unapproved homeopathic drug products are illegal and direct all manufacturers to immediately remove such products from the market. In the meantime, as we have recommended for many years, consumers should not use homeopathic products. At best, the products are a waste of money, given the lack of any evidence that they are effective. At worst, they could cause serious harm because of the lack of FDA oversight to ensure safety.
 

References

[1] Food and Drug Administration. Homeopathic drug products: Guidance for FDA staff and industry. December 2022. https://www.fda.gov/media/163755/download. Accessed February 15, 2023.

[2] Food and Drug Administration. Homeopathic products. March 20, 2018. https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm589282.htm. Accessed February 15, 2023.

[3] A review of homeopathy. Worst Pills, Best Pills News. October 2009. https://www.worstpills.org/newsletters/view/662. Accessed February 15, 2023.

[4] Ibid.