FDA Homeopathic Drugs

FDA Homeopathic Drugs are subject to a new enforcement policy that could lead to big changes. Current homeopathic drugs are the subject of a Compliance Policy Guide (CPG), which is an explanatoryatory note for FDA staff and industry.  As CPG Sec. 400.400 explains, the FDA recognizes and permits homeopathic drugs recognized by a Homeopathic Pharmacopeia. This requires following the ‘like-treats-like’ principle of homeopathy (The practice of treating the syndromes and conditions which constitute disease with remedies that have produced similar syndromes and conditions in healthy subjects). FDA homeopathic drugs often become a hide out for herbal products or traditional medicines that don’t fit into an FDA OTC monograph and would require an expensive New Drug Application (NDA). Under the new enforcement policy these products may gain new scrutiny.

The FDA’s new proposed approach prioritizes enforcement and regulatory actions involving unapproved drug products labeled as homeopathic based on risk. Those products with the greatest potential to cause risk to patients will be removed from the market. Under a Draft Guidance articulating this approach the FDA intends to focus its enforcement authorities on the following kinds of products:

• products with reported safety concerns;
• products that contain or claim to contain ingredients associated with potentially significant safety concerns;
• products for routes of administration other than oral and topical;
• 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 that do not meet standards of quality, strength or purity as required under the law.

Examples of products that may be subject to the enforcement priorities in the draft guidance are infant and children’s products labeled to contain ingredients associated with potentially significant safety concerns, such as belladonna and nux vomica; and products marketed for serious conditions, such as cancer and heart disease.

The FDA’s homeopathic drug enforcement approach follows a similar update from the FTC last year.

Contact our Washington D.C. or Research Triangle office with any questions.

**Disclaimer: Marc C. Sanchez, Esq. is a FDA attorney in private practice and the above is not intended as legal advice. FDA Atty law firm is hosting this blog solely for educational purposes.**