The FDA has proposed a new policy for regulating homeopathy—a policy which is a direct threat to many, many homeopathic medicines. To fully protect consumer access to these treatments, our US colleagues need Congress to pass a law.
Congress and the FDA have always exempted homeopathy from the same drug requirements as pharmaceutical drugs. Now the FDA, with pressure from big pharmaceutical companies who compete with homeopathic medicine, wants to create an unnecessary policy. The FDA’s new policy states that no homeopathic medicines have been “generally recognized as safe and effective” (GRAS/E) by the FDA or gone through traditional FDA drug approval; therefore technically speaking all homeopathic medicines currently on the market are being sold illegally. However, the FDA said it would prioritize enforcement on products with safety concerns.
Homeopathy has grown into a $3 billion market with increasing demand from consumers looking for alternatives to prescription medicine.
In response to the FDA’s new proposal, homeopathy advocates are arguing for a return to the Compliance Policy Guide (CPG) used since 1988.