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Watch Your Language: Homeopathic health claims

The area of homeopathic medicine is a hazy gray territory. By law, homeopathics are defined and approved as medicine, ie drugs not dietary supplements. Homeopathic medicine was first introduced by German physician Samuel Hahnemann in 1796 to treat patients and in 1938, FDA approved homeopathics for sale as over the counter drugs.

Today, Homeopathic Pharmacopeia of the United States (HPUS) serves as a compilation of standards for source, composition, and preparation of homeopathic drugs. It is recognized as an official compendium under Section 201(j) of the Federal Food, Drug, and Cosmetic Act. An OTC homeopathic drug must have at least one OTC indication as listed in the HPUS and may not be combined with dietary supplement ingredients such as botanicals.

Only homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed as an OTC homeopathic. This means even though FDA classifies homeopathics as OTC drugs, there are very specific health claim restrictions. One can get in trouble if the guidelines are not followed.

Recently, some marketers of dietary supplements have added homeopathic remedies to their product line in hopes of selling a product that is not as vulnerable to FDA watchdogs as dietary supplements. And recently some companies have taken liberties in marketing homeopathic products with disease claims, also thinking FDA will not notice. Apparently FDA is watching.

A recent FDA warning letter to one company made this abundantly clear. The company has seven homeopathic remedies that were advertised for diseases that should only be treated by a physician, including tumors, pleurisy, epilepsy, diabetes, gout and rheumatism, pulmonary disorders and measles. All are clearly disease claims, which mean these products, may not be sold as an OTC homeopathic. If a company wishes to follow the disease claim route, they must be approved by FDA as a prescription medication.

The FDA takes this position: "We note that at least one component of the product is recognized in the Homeopathic Pharmacopeia of the United States (HPUS). Please be aware that a product's compliance with requirements of the HPUS does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use."

In other words, just because the ingredients are listed in the Homeopathic Pharmacopeia of the United States (HPUS) does not necessarily mean it can be sold as a product that can cure diseases, hence this notation from FDA:

"You have failed to require that your product be dispensed under a prescription from a duly licensed practitioner. Therefore, your product is misbranded under section 503(b)(1) of the FD&C Act, and is marketed in violation of sections 301 (a), 301 (b), and 301 (k) of such Act."

Diseases that are considered self-limiting and suitable for self-medication can be treated with OTC homeopathics. Unfortunately, the FDA does not specify which diseases are appropriate for self-medication, but a good rule of thumb is to refrain from marketing or advertising the product as a "cure" or a "preventative" means for diseases. The law states that only drugs can do that.

Remember, watch your language. Then, you won't have to watch your mail.

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