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Critique of Proposed Regulations of Homeopathic Medicines and Alternative Proposals

homeopathic remedies

Story at-a-glance -

  • At a time in history when governments are reducing regulations, the Food and Drug Administration (FDA) is planning to increase its regulation on homeopathic medicines, despite their longtime history of being the safest medicines presently available
  • The FDA is planning to nullify its previously established guidelines on the regulation of homeopathic medicines and replace them with a risk/benefit analysis that will increase the enforcement of homeopathic medicines that it deems to have a “higher risk” of danger
  • The FDA claims that certain homeopathic medicines have been “associated with” an increased number of side effects and a small number of deaths, though, to date, no homeopathic medicines have been proven to contain toxic amounts of a drug ingredient
  • The FDA is proposing an increase in regulation of homeopathic medicines sold to “vulnerable” populations, such as pregnant women, infants, children and the elderly, even though the 200-plus years’ remarkable history of safety makes the use of homeopathic medicines to be a preferred method of treatment for these groups of people

By Dana Ullman, MPH, CCH

In December 2017, the U.S. Food and Drug Administration (FDA) announced their interest in protecting consumers from "potentially harmful, unproven homeopathic drugs." The FDA is proposing to nullify its previous guidelines by which homeopathic medicines can be marketed. Instead, the FDA would deem all homeopathic medicines to be "unapproved new drugs," which would make them subject to enforcement based on the perceived "risk/benefit" of a specific drug.

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