Homeopathy is a term translated from Greek-homeos meaning similar and pathes meaning suffering. Born out of that translation is a concept defined by the principle of similars, or Similia Similibus Curentur, that has captured a small but loyal following since the late 18th century.

According to the National Center for Homeopathy (NCH), Alexandria, VA, homeopathic medicines are drug products made by homeopathic pharmacies in accordance with the pro­cesses described in the Homeopathic Pharmacopoeia of the United States (HPUS), which is the official manufacturing compendium recognized by the U.S. Food and Drug Administration (FDA). The substances may be made from plants such as aconite, dandelion, plantain; from minerals such as iron-phosphate, arsenic oxide, sodium chloride; from animals such as the venom of a number of poisonous snakes or the ink of the cuttlefish or even from chemical drugs such as penicillin or streptomycin. These substances are serially diluted with vigorous shaking (called succession) at each step until little of the original remains. The NCH said it is important to remember that a medicine is homeopathic only if it is taken based upon the similar nature of the medicine to the illness. A medicine labeled as "homeopathic" will only work if it is homeopathic to the symptoms presented.

Relating the concept of homeopathy was J.P. Borneman, chairman and CEO, Standard Homeopathic and Hylands, Los Angeles, CA, and board member of NCH, who said it is best explained through an example. "Homeopathy is based on the belief that like treats like. In other words, if a healthy person develops symptoms from a pharmacologically active substance and an afflicted person has that same symptom complex from another cause, a homeopathic dose of the substance that would have caused symptoms in a healthy individual may relieve the symptoms in the afflicted individual," he said, adding, "This is very much akin to early vaccine theory. The first vaccine that was developed was Jenner's vaccine for smallpox, which was developed from cowpox because the observation was that milkmaids would develop cowpox but were immune to smallpox."

The Man Behind the Concept

A German doctor by the name of Samuel Hahnemann is considered the father of homeopathy. Due to his dissatisfaction with the ways of practicing medicine in the 18th century, he actively pursued an alternative to medical therapies of the time. Dr. Ronald Boyer, medical director of the Boiron Institute, Newtown Square, PA, discussed homeopathy's be­­ginnings. "Dr. Hahnemann started by translating books and in one of the books he was translating by a Scottish physician named William Cullen, he took particular interest in Dr. Cul­len's suggestion that quinine could be administered in patients to fight off malaria (then called intermittent fever) because it was bitter," he said. "Dr. Hahnemann found this strange because he said there were a lot bitter things on earth and didn't know why this specific bitter substance should have an effect against in­termittent fever." At this, Dr. Hahnemann decided to take quinine himself. To his astonishment, taking quinine in large doses created on himself the symptoms of malaria, which is the disease that quinine was supposed to treat. Dr. Boyer said, "Dr. Hahnemann found it interesting that a substance that could treat a disease could create the same symptoms as the disease itself."

Homeopathy started to gain mo­mentum in the U.S. around the 1820s and lead to a peak interest in the late 1800s, according to Joe Lillard, president, Washington Homeopathic, Bethesda, MD, and vice president of NCH. "Into the 1880s and 1890s, 25% of doctors in the U.S. considered themselves homeopathic practitioners," he said, adding "Then came an effort in 1910 through what is referred to as the Flexner Report to standardize the teaching of medicine in the U.S. This new standard of teaching was to be applied to all homeopathic and allopathic hospitals and teaching institutions." Al­though the standards set forth were reasonable, according to Mr. Lillard, there were many homeopathic hospitals and institutions that did not fall in line. "In my opinion they really hurt themselves by not being more in line in teaching anatomy and chemistry," he said. "It wasn't the report that changed the fate of homeopathy, rather it was the response by homeopaths not to act on the standards set forth by the report."

Today homeopathy in the U.S. has become more of a self-medicating practice. But the potential of homeopathy, according to Fabienne Pug­netti-Boiron, public relations manager, Boiron USA, Newtown Square, PA, goes way beyond self-medication, which is why there is a huge difference between the way it is used in Europe and the way it is used in the U.S. "Homeopathy is a very popular and common mode of treatment in Europe and it has always been in the hands of physicians. In France, for example, more than 40% of the population is under homeopathic treatment whereas in the U.S. only about 3-5% of the population is using homeopathic medicines on a regular basis," she said, adding. "Furthermore, 40% of the medical doctors in France prescribe homeopathic medicines and 100% of the pharmacies have homeopathic medicines in stock."

Trends

According to SPINS, San Francisco, CA, homeopathic medicines represented $31.6 million of sales in natural product supermarkets-which is where the core customer's of homeopathic medicines are in the U.S.-for 52 weeks ending June 2002 (see figure 1). In that same period the category grew 13%.

The top 10 homeopathic brands in natural product supermarkets-not including Cold-Eeze or Zicam, which primarily target the mass market-accounted for $29.5 million of total sales, pointing to strong brands with staying power. These companies included Boiron, Boericke & Tafel, Hylands, BHI, Natra Bio, Similasan, Liddell, Newton, Nelsons and Bioforce (see figure 2).

The mass market for homeopathic remedies is a different story. According to John Durkin, director of sales, Boiron, sales of homeopathic medicines in the food, drug and mass (FDM) market were $44 million for 52 weeks ending July 2002, exhibiting a growth of 19% from the year before. "That number may be a little distorted because sales of Zicam are included in that number and Zicam's sales alone represent $21 million," said Mr. Durkin. "Zicam has really been positioned in the mass market and has stayed away from the natural foods retailers. Just to put it in perspective, sales of Zicam in natural products supermarkets total $13,000."

Awareness is low but growing due to the self-care trend that has continued to proliferate the U.S. population. "People are becoming more a-ware of the category and are more able to differentiate it from herbs and 'home remedies.' Women in particular have a sensitivity towards homeo­pathy and will take the time to learn what it is all about, not only for themselves but also for their family," said Mr. Lillard. "While this is a positive trend, homeopathy is expensive and it is hard to figure out how to get these medicines into the hands of people that don't have much money."

According to Ms. Pugnetti-Boiron, building awareness is a long term pro­cess that her company is working toward. "The medical community needs to be aware of the potential of homeopathic medicines and what we are working toward is implementing accessible courses and teaching tools to help physicians include homeopathic medicines in their practice," she said. "Our goal is to give to every practitioner the possibility of including homeopathy as a therapeutic tool."

Regulatory Issues & Distribution Channels

In 1938 the Food, Drug & Cosmetic (FD&C) Act was passed and it included homeopathy as a drug
therapy within the meaning of that act. Discussing the FD&C act in more detail was Mr. Bor­neman. "Part of the act in 1938 was the fact that the government sanctioned the Homeopathic Pharmaco­poeia of the U.S. (HPUS), which is a federally recognized compendium of standards for the production of homeopathic medicines," he said. "Consequently, what you see on the bottle, if it is made ac­cording to HPUS standards (which it should be to pass FDA muster), is pretty much the same from company to company. Additionally, ho­meo­pathic manufacturers are also required to follow drug GMPs."

Ironically, on the 50th anniversary of the FD&C act in 1988, FDA passed compliance policy guides for the marketing and sales of homeopathic medicines, which are the operative guidelines under which the industry works. Explaining the significance of the compliance guides was Mark Land, technical manager for Boiron. "FDA about 15 years ago realized that the regulations that were written were very basic in relation to how a process should be undertaken or how a product label should be defined. According to FDA, there wasn't enough in­formation in the regulations to address all of the specific needs that a wide and very varying industry might need. Because the process of changing regulations is difficult and because it spans such a wide range of applications, FDA undertook a process of what they called compliance policy guides," he said, adding, "The idea was to produce a document that would guide both FDA and the homeopathic industry in very fine detail regarding specific processes or regulations. These guides were developed to help FDA, specifically their field force, evaluate homeopathic manufacturers as well as to create a common language that manufacturers would work toward in order to be in compliance with expectations of FDA." The compliance guides were developed jointly between the homeopathic industry and the compliance affairs division of FDA and explain what a homeopathic medicine is, what the differences are between a homeopathic over-the-counter (OTC) medicine and a prescription homeopathic medicine, how they should be labeled and how the process by which they are made, should be controlled.

In terms of the claims that can be made on products, Andy Bormeth, president, American Association of Homeopathic Pharmacists (AAHP), commented on the types of claims that are allowed for homeopathic medicines. "Within the homeopathic market the claims that can be made fall into the OTC drug arena. When you get to prescription type products the prescriptions must be written by a doctor and dispensed by a pharmacist or a doctor," he explained. Mr. Bor­meth said in order to make claims they have to be within the realm of what FDA considers OTC and said there are three criteria to follow: (1) That you are dealing with a self-limiting disease. (2) That the condition is self-treatable.(3) That the condition is self-diagnosable. As an example, he said, "The common cold meets all three of the criteria. It is self-limiting because it goes away after two weeks. It is self-diagnosable because people know when they have a cold. It is also self-treatable be­­cause there are medications that you can take orally, it doesn't have to be administered in an intravenous (IV) fluid."

In the latter part of the 19th century and the early part of the 20th century homeopathy was exclusively a province of physicians, so the sales were to physicians that dispensed them out of their office. However, with the change in the regulatory environment sales began to move to other channels. Mr. Borneman commented on the transition. "The growth of the natural foods channel toward mid-century began to open up as an outlet to sell homeopathic medicines directly to consumers through retailers. Similarly, companies began to sell direct to consumers via catalog and mail order at about the same time," he said. "By the time 1985 hit, the dominant channel was health food and in 1990 the direct to consumer sales had surpassed the direct to physician sales." By 1995 things changed again as the most important channel became FDM, with natural foods coming in at about a fifty/fifty mix with that channel."

Homeopathic Medicines vs. Dietary Supplements

There are many differences than "similars" when it comes to comparing dietary supplements and homeopathic remedies. One could even say the only similarities between the two categories are the customer base and channels of distribution.

If a dietary supplement company were looking to incorporate homeopathic medicines into its existing line of products, it would have to meet GMP standards as well as develop homeopathic medicines under the guidelines set forth by the HPUS. If these two standards were met, a company could reap the benefits of being able to better market the quality of its products and it could take advantage of stronger label claims.

Mr. Bormeth discussed the differences in the labeling and classification of these products. "There are number of ways to differentiate between a ho­meopathic product and a dietary supplement. First of all, with a homeopathic drug you will have to list the word 'homeopathic' somewhere on the primary label. In addition, most homeopathic drugs have what's called a national drug code or an NDC number, which signifies a product's listing with FDA. However, an NDC number is not required, so not ALL homeopathic medicines will have an NDC," he said, adding, "You will also see a drug facts panel or a similar set of information on a homeopathic product, which will tell you how to use it, what the active is and what the inactives are as well as detail the warnings. Pharmacists are very attuned to the drug facts panel to be able to standardize where to look for informa­tion for their customers."

Though the two industries remain separate entities, the shared experience of dealing with unscrupulous practices is something with which both industries can identify. For the future, Mr. Bormeth speculated, "In both the dietary supplement and homeopathic market, more and more companies are pushing the envelop in terms of what you can say on the label. I see more and more risky products out there in terms of the claims they are making and products that are going on store shelves. Until FDA enforces the rules that are out there right now, there will be more companies willing to take that risk."NW