Although FDA regulates homeopathic remedies, enforcement has lagged especially in comparison with the popularity and increased use of homeopathic remedies . Finally in late 2017, FDA issued a draft guidance entitled Drug Products Labeled as Homeopathic.” 

The draft guidance explains how FDA expects to prioritize enforcement and regulatory action with respect to drug and biological products, labeled as homeopathic and marketed in the United States without the required FDA approval. Once the final guidance is issued, FDA will withdraw Compliance Policy Guide (CPG) 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed”, issued back on May 31, 1988.

What is homeopathy? The guidance defines homeopathy as follows: “Homeopathy is an alternative medical practice that has an historical basis in theory and practice first systematized in the late 1700s. Homeopathy is generally based on two main principles: (1) A substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses (known as “like-cures-like”) and (2) the more diluted the substance, the more potent it is (known as the “law of infinitesimals”).”

The definition of “drug” in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 321(g)(1)) includes articles recognized in the Homeopathic Pharmacopoeia of the United States (HPUS) or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs. Senator Royal Copeland, was a physician and homeopathic proponent and finally a major sponsor of the 1938 FDCA.

What does the guidance state about enforcement? According to FDA, the agency recognizes resource limitations and intends to apply a risk-based enforcement approach to drug products labeled as homeopathic and marketed in the United States without the required FDA approval. Further, FDA expects to apply a risk-based enforcement approach to the manufacturing, distribution, and marketing of drug products labeled as homeopathic.  Categories include:

Products with reported safety concerns;

Products that contain or purport to contain ingredients associated with potentially significant safety concerns;

Products for routes of administration other than oral and topical—For example, unapproved injectable drug products and unapproved ophthalmic drug products pose a greater risk of harm to users due to their routes of administration;

Products intended to be used for the prevention or treatment of serious and/or life- threatening diseases and conditions;

Products for vulnerable populations; and

Products deemed adulterated under the Food, Drug and Cosmetic Act.


https://www.federalregister.gov/documents/2017/12/20/2017-27157/drug-products-labeled-as-homeopathic-draft-guidance-for-food-and-drug-administration-staff-and Federal Register Vol. 82, No. 243 (December 20, 2017) Notices 60403






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