A Better Way to Regulate Homeopathy

Homeopathy consumer group petitions FDA as product removals loom

A leading organization of homeopathy consumers has petitioned the U.S. Food and Drug Administration (FDA) to adopt a set of rules governing homeopathic medicines that it says will do a far better job of protecting consumer interests than the agency’s proposed rules released late last year.

The FDA’s proposal could lead to the removal of many popular homeopathic medicines from the market according to Paola Brown, president of Americans for Homeopathy Choice (AFHC), the consumer-led advocacy group which filed the petition.

In fact, the threat is no longer theoretical. The FDA recently halted imports of injectable homeopathic medicines used by many patients in the United States for both chronic and acute conditions. It sent warning letters to domestic manufacturers as well. The agency has been sued, and the import ban is now before a federal judge.

The AFHC petition seeks to counter such moves by providing “an appropriate framework that represents what the FDA should have been doing from the beginning of this process based on how they have treated homeopathy in the past,” Brown said.

She urges those wishing to make a comment to the FDA on the petition to visit the AFHC website for instructions on how to do so.

James S. Turner, legal counsel for the group, said the petition is “a bill of rights for homeopathy consumers.” And, it is designed to force the agency to adopt a proper administrative process for making rules regarding homeopathy.

Turner explained that the petition is essentially telling the FDA to reaffirm that the agency has been correct all along when it created a special category for homeopathic medicines based on the 1938 Food, Drug and Cosmetic Act, a category distinct from allopathic drugs.

Allopathic drugs are inherently dangerous and only deemed useful if the benefits outweigh the risks. Homeopathic medicines are inherently safe and have many benefits, Turner said. There have been no demonstrated risks in taking properly manufactured and labeled homeopathic medicines.

“The FDA now wants to change its rules arbitrarily in violation of federal law without any evidence of harm,” Turner added.

The FDA is required by law to respond to the AFHC petition within six months or seek an extension to respond. The deadline for the FDA response comes in early December. Brown said the agency could ultimately respond in one of three ways:

1. Announce it will adopt the rules proposed in the petition.
2. Revise the agency’s own proposed rules called “guidance” in ways consistent with the petition.
3. Reject the petition.

Anything short of adopting the rules proposed in the petition would allow AFHC to go to federal court and makes its case before a judge.

No matter what happens, a show of public support will give the organization more leverage to affect change. “Anyone around the world is allowed to make comments on the petition,” Brown said. “The more comments there are, the bigger the impression on the FDA and members of the U.S. Congress,” she added.

For more information about showing your support for the petition, visit https://homeopathychoice.org/fdacomment/

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