By J.P. Borneman, Ph.D. and Alvin J. Lorman
Homeopathic drugs, we proudly tell folks, really are drugs: the Federal Food, Drug, and Cosmetic Act has recognized them as such since its passage in 1938. Being characterized as a drug has many implications: our products are subject to current Good Manufacturing Practices, they must be produced in registered establishments, and they must comply with various labeling requirements. Labels for homeopathic drugs have been a source of concern for decades, only partially resolved by the 1988 Compliance Policy Guide on homeopathy.
Probably the biggest continuing issue, both for industry and for the Food and Drug Administration (FDA), is the difference between a prescription (Rx) and an over-the-counter (OTC) drug. The distinction has never been cast in concrete; as times change, so does FDA’s views on what constitutes “adequate directions for use.” That phrase is the statutory standard; a drug is deemed to be misbranded unless its label bears “adequate directions for use.” FDA has always interpreted that phrase as meaning “adequate” for a layman. In fact, the prescription legend was initially created by FDA as an exemption to the adequate directions for use requirement.
The difference between an Rx and an OTC indication has always caused problems; to the surprise of many, FDA does not maintain a list of acceptable OTC indications. For allopathic drugs, clarity has emerged through the OTC Review: a final monograph ends speculation about the appropriate claims for that class of drugs. But what about for homeopathic drugs, which are not part of the OTC Review? It is clear that if FDA accepts as OTC an indication for an allopathic drug, then that indication can also be used for a homeopathic drug. In some monographs, FDA has found no active ingredients to be generally recognized as safe and effective but has left the indication available as an acceptable OTC claim. But what about potential OTC indications that FDA has never examined? For years, products with those indications have been marketed with relatively little objection. (We are not talking here about clear Rx indications, such as treatment of cancer or vaccines.) More recently, however, some FDA inspectors have taken the position that the only acceptable OTC indications are those recognized by the agency in the OTC Review or by approved New Drug Applications. This issue remains unresolved.
Another recent issue arises from the use of the Drug Facts label. While not required for homeopathic drugs, they are often used for these products. Manufacturers of homeopathic drugs struggle to figure out what to say in the “Purposes” section; for an allopathic drug, that is generally simply the pharmacologic class of the ingredient. Remember, however, that FDA will look at the Purposes section to see if you are using words that expand the “Uses” of the drug. The Purposes should stick closely to the Uses to avoid trouble.