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Does the Food and Drug Administration (FDA) review and approve homeopathic drugs?
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 any other prescription and OTC drugs.[1] 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...
Does the Food and Drug Administration (FDA) review and approve homeopathic drugs?
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 any other prescription and OTC drugs.[1] 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 and effectiveness.
The term “homeopathy” is derived from the Greek words “homeo,” meaning similar, and “pathos,” meaning suffering or disease.[2] A German physician named Samuel Hahnemann introduced homeopathy in the late 1700s.[3] 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.
In fact, although the labeling for homeopathic drugs in general indicates that the ingredients are highly diluted, the FDA has identified some products that contained amounts of active ingredients that could cause significant harm to patients.[4] For example, in January 2017, the FDA warned the public about certain homeopathic products marketed for infant teething that contained dangerous levels of the toxic substance belladonna,[5] which had been linked to infant seizures and deaths.[6] 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. Consumers can identify such products by looking for the term “homeopathic” on the package label and checking for ingredients that are listed in terms of dilution factors (for example, “1X,” “6X” or “2C”).[7]
References
[1] Food and Drug Administration. Homeopathic products. March 20, 2018. https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm589282.htm. Accessed May 7, 2019.
[2] A review of homeopathy. Worst Pills, Best Pills News. October 2009. /newsletters/view/662. Accessed May 7, 2019.
[3] Ibid.
[4] Ibid.
[5] Food and Drug Administration. FDA confirms elevated levels of belladonna in certain homeopathic teething products. January 27, 2017. https://www.fda.gov/news-events/press-announcements/fda-confirms-elevated-levels-belladonna-certain-homeopathic-teething-products. Accessed May 7, 2019.
[6] “Natural” teething remedies also may be deadly. Worst Pills, Best Pills News. July 2017. /newsletters/view/1139. Accessed May 7, 2019.
[7] Food and Drug Administration. Homeopathic products. March 20, 2018. https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm589282.htm. Accessed May 7, 2019.
