Regulatory Exposure

Exploring a new market like homeopathic medicines may limit your regulatory risks when making express or implied disease claims.

By Todd Harrison

The nutritional supplement marketplace is extremely competitive. To get your message out, companies either flirt with making express disease claims or simply decide to ignore the prohibition against such claims and make disease claims anyway. The calculus for many companies is simple. What is my regulatory exposure for making an express claim? There are two different regulatory risks, the FDA and the FTC. With the FDA, if the worse case scenario is a warning letter, some companies will decide to make the disease claim. The FTC risk assessment is more difficult to make and should depend on the level of substantiation the company has for the product or its ingredients. Although, a review of FTC enforcement cases over the last 10 years indicates that the FTC will generally initiate an investigation if the claim relates to losing a significant amount of weight without any changes in diet and exercise or relates to a serious disease condition(s), e.g., Alzheimer, cancer; there have been a couple of cases where minor conditions were involved. Additionally, the advertising in question was more likely to appear on television as a long form infomercial. Thus, based on the claims being made, many companies will make the business decision that their regulatory exposure is low and move forward with making disease claims. (I would be remiss to state that low regulatory exposure does not mean “zero” exposure. So if a company has minimal substantiation and the FTC comes knocking at the door, their exposure can be quite significant.)

For instance, many companies will make claims regarding cold, flu, allergy, and the relief of minor aches and pains. The interesting issue about these types of low risk disease claims is that there is actually a developing market out there that allows companies to make express disease claims that are similar to over-the-counter (OTC) drug claims that have generally received limited FDA and FTC scrutiny. The category I am referring to is homeopathic drugs. Homeopathic drugs are natural medicines that are generally made from herbal ingredients that are commonly found in dietary supplements. However, they are regulated very differently and companies are permitted to make express disease claims.

Homeopathy is the “practice of treating the syndromes and conditions which constitute disease with remedies that have produced similar syndromes and conditions in healthy subjects” (FDA Compliance Policy Guide 7132.15). A homeopathic drug is “any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.” Any substance may be categorized as homeopathic if it meets two basic requirements: (1) the substance has known “homeopathic provings” and/or known effects which mimic the symptoms, syndromes, or conditions which it is administered to treat, and (2) the substance is manufactured in accordance with the specifications of the HPUS.

The HPUS is a compilation of standards for source, composition, identity, and specifications for preparation of homeopathic medicines. The HPUS does recognize combinations of homeopathic medicines, provided each component is listed in the HPUS. Both FDA and HPUS treat products that contain homeopathic and non-homeopathic ingredients as non-homeopathic products. In other words, one cannot mix the concept of a dietary supplement with a homeopathic drug, albeit, some companies have done so. One possible way of achieving this result is to simply state that the homeopathic drug is in an herbal base. Indeed, neither FDA nor the HPUS require that inactive ingredients be recognized as homeopathic. Rather, the inactive ingredients must be safe in the amounts administered and must not interfere with the effectiveness of the preparation or with suitable tests or assays to determine if the product meets its professed standards of identity, strength, quality and purity.

The HPUS permits homeopathic products to be sold in powder, pellets, tablets, triturates and cones form. Tinctures, liquids, and solid attentuations also may be sold as suppositories, ointments, gels or lotions for topical use. In other words, homeopathic drugs are not limited to ingestibles. Thus, for those companies looking to market cosmeceuticals, they may want to consider whether its product could qualify as a homeopathic drug in the first instance.

The product label and manufacturing process of the product must strictly adhere to the regulations set forth in the HPUS. The potencies of homeopathic drugs are specified in terms of dilution, i.e., 1x (1/10 dilution), 2x (1/100 dilution), etc. Homeopathic drug products must contain diluents commonly used in homeopathic pharmaceutics.

Unlike dietary supplements, homeopathic products may make claims that the product is intended for use in the diagnosis, cure, mitigation, treatment or the prevention of disease. However, to determine whether a particular claim is appropriate for a homeopathic product, FDA relies on the ingredient descriptions provided in the Dictionary of Practical Materia Medica by John Henry Clarke. The FDA also recognizes other homeopathic Materia Medica such as the Homeopathic Materia Medica by William Boeriocke. In the Dictionary of Practical Materia Medica, each ingredient listing contains a list of symptoms that the ingredient is known to cause. For example, an OTC homeopathic cold remedy on the market contains ingredients that are listed in the Dictionary of Practical Materia Medica as causing the following symptoms: sneezing, runny nose, nasal congestion and minor sore throat.

From an FTC perspective, OTC homeopathic drugs represent a unique challenge. The FTC would prefer to apply typical western standards to marketing of these products. This means the products should have competent and reliable scientific evidence to support the claims. However, that is not the standard re-quired to market these products under the Federal Food, Drug and Cosmetic Act. Indeed, the FTC would have a difficult time challenging an advertisement for a homeopathic drug as long as the claims are limited to claims appearing in one of the sources mentioned previously. With that said, if a claim states or implies that it has scientific support, e.g., clinical study, or makes a comparative or superiority claim, the FTC would re-quire competent and reliable scientific evidence to support the claim. Thus, carefully crafting your claims to stay within homeopathic medicine should help a company avoid close scrutiny by the FTC.

To market a homeopathic drug as an OTC remedy, it must meet certain criteria. In this regard, only products in-tended for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and self-treatment may be marketed OTC. Examples of self-limiting conditions include colds, head-aches, and other minor health problems that eventually go away on their own. Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products. If a homeopathic drug claims to treat a serious disease, such as cancer, it can be sold by prescription only. Additionally, if the HPUS specifies a distinction between nonprescription (OTC) and prescription status of products that is based on strength (e.g., 30x) which is more restrictive than Section 503(b) of the Act, the more stringent criteria will apply.

There are other requirements that have to be met such as registering and listing with FDA, but space runs short and I must end this article by simply stating that homeopathic remedies provide an opportunity for the responsible company that desires to make express disease claims for disease conditions that are self-limiting and capable of self-diagnosis and treatment.NW