Body, heal thyself
- How Homeopathic Products Are Made
Homeopathic preparations are made through repeated dilution. Homeopathic products start with plants, minerals or animal products. These substances are first crushed and dissolved in a liquid, usually grain, alcohol or lactose. Homeopaths then dilute the preparation with more alcohol or lactose, either 1 part to 10 (written as “x”) or 1 part to 100 (written as “c”). Dilution is repeated until the final product is chemically indistinguishable from the dilutant. Homeopathic products are available in a wide range of forms, including tablets, gels, creams, liquid drops, tinctures and sugar pellets.
- Homeopathy Regulations
The U.S. Food and Drug Administration has not approved any products labeled as homeopathic.
“Products labeled as homeopathic and currently marketed in the U.S. have not been reviewed by the FDA for safety and effectiveness to diagnose, treat, cure, prevent or mitigate any diseases or conditions,” according to the FDA’s website. “Products that have not been evaluated for safety and effectiveness may harm consumers who choose to treat serious diseases or conditions with such products, and consumers may be foregoing treatment with a medical product that has been scientifically proven to be safe and effective.”
The agency issued a final guidance on homeopathic drug products on Dec. 6, 2022, that outlines its approach to prioritizing regulation, which is available at https://www.fda.gov/media/163755/download. As needed, the FDA will issue alerts, warnings and recalls if it has concerns about specific products, such as potential health risks or contamination. The FDA recommends consumers talk to their doctor or health care professional about safe and effective treatments for their disease or condition.
Homeopathic products are regulated under the Federal Food, Drug and Cosmetic Act of 1938 . For decades, these products were typically prepared by homeopathic physicians for individual patients. Nowadays, they are frequently mass manufactured and widely marketed as over the counter products.
The FD&C Act recognizes the Homeopathic Pharmacopeia of the United States as the official reference for the identification and quality standards of homeopathic starting materials and tinctures. The HPUS also describes manufacturing methods and standards for compliance with homeopathic products. The initials “HPUS” on the label of a drug product indicate the active ingredients are found in the official reference and assures the product conforms to those legal standards of strength, quality, purity and packaging.