Alternative health group sues FDA over plan to block homeopathic remedies

An alternative health group has filed a lawsuit against the US’s Food and Drug Administration (FDA) over its new regulations that could take homeopathic remedies off the shelves.

Under the new ruling, the FDA is treating homeopathic remedies as ‘new drugs’ that need to pass through safety trials before they can be offered to the public.  Pre-market clinical trials, which new pharmaceutical remedies must pass before they can be prescribed, can cost many millions of dollars.

The Alliance for Natural Health US is arguing that the new measure violates federal law and ignores a Congressional ruling that recognises homeopathic remedies as being different from pharmaceutical drugs and can operate under a more relaxed regulatory framework.

This difference, which includes the unique way the remedies are made together with their excellent safety record, was recognised in the Food, Drug and Cosmetic Act, legislation that is more than 80 years old.

But guidance issued by the FDA in 2022 bypasses the act’s protection of homeopathy, argues the ANH.  The group has issued the lawsuit along with homeopathic products manufacturer Meditrend against Robert M Califf, the FDA’s commissioner.

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