Supplements vs. "Treatments" - A Primer in Product Claims

We sell to countries all over the world - although the vast majority are English-speaking nations. Still, being a Bahamian company, people are surprised to hear us use language on pages throughout our site that appear to imitate the presentations of distinctly U.S. alternative health care companies. Specifically, we have frequently received questions that invariably sound something like this: "You say that (such and such product) is a nutritional supplement or an 'adjunct,' and NOT a treatment or a cure for any disease. If this is so, why do you link to a testimonial page where many people claim to have been cured."
Such a seemingly obvious contradiction deserves a thoughtful response.
There is no question that our presentation of materials is, at least in this one respect, unduly influenced by the legal milieu and political machinations of the food and drug bureaucracy in the U.S. Put yourself in our shoes: our city of Freeport is just 90 km. (56 miles) from Fort Launderdale, Florida, and the U.S. remains one of our bigger markets. The jurisdiction of the U.S. Food & Drug Administration isn't confined to the U.S. We learned very early on that it wields an influence that is worldwide - to the consternation of many of the other 185-plus countries in the world, many of which have ethnobotanical and other medicinal cultures that are not at all homogenous with more narrow Western thinking concerning all things health-related.
Example: In 1995 one of Alpha Omega's top herbalists travelled to Chernobyl, in what is now Ukraine (part of the U.S.S.R. when the nuclear disaster struck in 1986). His mission was to help with some of the thousands of officially unreported cases of skin cancer that have developed in the 15-plus years since the accident - cases which are but a small part of its long-term health consequences.
In the process of videotaping the results of Cansema Salve on skin cancer sufferers there, he was surprised to hear Ukrainian doctors tell him it was too bad they couldn't officially use the product (which we were willing to donate) to help with their skin cancer case load. "Why?" our herbalist asked. "Because even here, almost halfway around the world, your Food and Drug Administration would never allow it," was the reply. (Throughout Asia, if you speak English, and you come from North America - well, you simply MUST be an American. By the way, we now have a small video clip taking during our sojourn to the Ukraine.)

This does not mean that progress is not possible. Since the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA, for short), there has been an easing of restrictions on supplemental products. (Hence, the ubiquitous appearance of that phrase, readable a thousand times in the aisle of any American health food store: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. [Section 403(r)(6)(C) of the Act.]." In deference to our American neighbors, and their ever vigilant customs officials, we ourselves have elected to follow these guidelines - to the confusion of our customers everywhere else.
Given that any food, any nutrient, any supplement, any drug, any promising technique, any anything that a patient or otherwise ill person has, is going to be USED to somehow ameliorate their disease or affliction, all this rubbish is bound to strike the average person as just so much legalistic, Clintonesque hair splitting. It is particularly nauseating to our senior customers, many of them coming to us only after being sent home to die - and only after their doctor unceremoniously announced that their condition was such he could no longer help them (and only coincidentally corresponding with an expiration in their HMO insurance coverage). Countless times, we have dealt with advanced Stage IV cancer patients in the U.S., doing our best to comply with relevant laws regarding health claims, only to be scolded with some variation of: "Enough of this nonsense, damn it. Just give me a straight answer!" To which we can only reply: "We're doing our very best..."

To understand how we could have possibly gotten ourselves into this predictament, it is important to go back in time and enter into the dark recesses of the economic, political, and cultural climate that would give rise to the Food, Drug & Cosmetic (FDC)Act of 1938, as Amended, and Amended, and Amended again. This is important, even if you're not American, because the propensity of U.S. policy makers to follow their manifest destiny of self-appointed policemen to the world, as demonstrated previously, goes on unabated in the area of health care. In all fairness to the FDA, and their mirrored drug agencies in other Western countries, it should be noted that their own historical renditions are not without merit. It is hard to imagine, for instance, a modern, prosperous free market economy without a system for inspecting its food plants, established standards for tolerances on known poisonous substances, the ability to prosecute those who would foist adulterated or misbranded drugs on the public, etc. Furthermore, we can hardly throw our hat in with the more virulent anti-government groups in the U.S. who think that the world would be a better place if you could somehow, by magic, just get rid of the FDA altogether. Nonsense. Since 80% of its functions are necessary, even critical, to protect the general public, how could you? If you could get rid of the FDA, you would only have to turn around and re-create an agency that was nearly just like it.
But that's the operative word. Nearly.
Rather than throw the baby out with the bath water, our focus is on one arcane piece of thinking that is part of the very cornerstone of the FDA and its fellow agencies. In terms of what we know today about the science of pharmacology, phytopharmacology, ethnobotany, and their related disciplines, much of this cornerstone is rigidly drawn from the 19th century. It is as if you passed a law that all practicing cartographers be not only licensed with the Flat Earth Society, but must share their philosophy about the earth, or they could not engage in map making. Where would modern physics be today if those in charge passed laws that the only acceptable knowledge that could be taught in the universities, applied in industry, and accepted for peer-reviewed publication, was that which could be found in 19th century textbooks on physics. We would simply ban all mention of Einstein, Bohr, Planck, Bose ... and commit ourselves to only those theories which would correspond with thoughts and theories of Galileo and Newton.
If the metaphor seems exaggerated, it most decidedly is not.
At the precipice of the health care crisis in the U.S., and elsewhere in the West, where costs are skyrocketing out of control, is the notion that any health claim concerning the curative properties of a given substance or compound must be based on a singular, pure, chemical entity - as opposed to the synergistic interactions of a number of medicinal compounds, as we see in plant medicine; that this claim is not legitimate unless it has been backed up by laboratory paperwork that is no longer measured in number of pages, or linear feet, but train-hauled boxcars; and that the threshold to obtaining the right to make this claim is set so high, in terms of financial requirements, that only an elite class of drug companies be able, for all intents and purposes, to obtain it. The result? The ability to have monopolist claim over a compound you may now call an "approved drug," a "treatment," - even a "cure." Whether or not your compound can effectively treat anything is, has, and continues to be, quite immaterial. Whether or not it is cost effective is immaterial. Whether or not there are disturbing side effects is, likewise, immaterial.
This has set in motion a practice that is now over a half century old, whereby drug companies no longer seek out proven remedies and attempt to market them. Instead, we have a system where companies seek out singular, chemical entities, obtain patents, and then go about the business of identifying their physiological effects on humans to see which diseases they might remotely have an effect on.
If you ran a car company, would you design your car first and create parts that fit that design? Or would you spend your time in the machine shop, creating oddly-shaped tooling and metal parts that no one had ever used before, and then say, "Let's see if we can build a car that could use this part! No one has ever used this funny part before us - so we'll have the only car that has one!"
Surely this wasn't the intent of those who sought to protect the public with better governmental oversight of the food, drug, and cosmetic supplies consumed by an unsuspecting public. But that is the prevailing insanity upon which the drug industry is built today.
Is this system profitable? Very.
Is it fair? This is debatable.
Is it an efficient system for bringing safe, effective remedies to the public? On the contrary, it is just the opposite - and the corruption it has woven into the fabric of the modern health care system has been documented many times over.

Lest our thoughts on the subject be viewed as a total assault on the sensibilities of the orthodox, we wish to make one important point: when we say that our products are adjunctive, that they are nutritional support products, we are quite serious.
The terms "treatment," "cure," and "prevent," are, in our mind, synonymous with the intervention of a health care professional. Granted, a good many of our users stick to self-administration of their health care products. This is almost never optimal. And most do it because they have to - not because they are rejecting the professional advice and care of an good physician, whose counsel is balanced, work is competent, and fees are reasonable. They behave as they do because, at least in terms of much public perception, the "good doctor" is an endangered species.
That so many people today REFUSE to see a physician when they are sick is not a testimony to the resourcefulness of consumers. Instead, it is a reflection of a health care system that is failing them, in no less a fashion than if people were forced to reject dentists and fill their own cavities; spurn electricians and foolishly attempt to wire their own homes; or scorn professional mechanics to rebuilt their own car engines - never mind their lack of familiarity.
Historians point to the work of Adam Smith ("Wealth of Nations," 1776) as ground zero for the creation of our modern, free market economies. In its very first chapter, Smith astutely points out the importance of division of labor in an advancing society. This is a principle that applies as much here as to any other in society: it is highly unlikely that the vast majority of consumers can, or even should, hope to replace the expertise of men and women who spend four years in medical school, several years in internship, and a lifetime thereafter devoted, quite often, to highly specialized areas of medicine, honing their craft - all with a devotion to finding effective treatments for their patients, who have invested their care, their trust, and all the vulnerabilities that are attendent therein.
For all that Alpha Omega Labs has done to help countless thousands of people, this is not our job. It is the job of your doctor - be it your M.D., N.D., D.O., D.C... or whatever modality you choose. If you cannot find a doctor with whom you feel comfortable, it doesn't mean you cannot obtain our products. But know that there is a better way and you can help, in your own way, to MAKE the system work better. Already, scores of doctors are using our products, not because they learned about them in medical school, but because they were shocked to see their patients' response to one of our products, so they emailed us and began a dialogue in earnest.
When we say that our products are adjunctive, and not a treatment or a cure, we impress upon our customers an important part of the health care system that isn't missing. It's just been temporarily broken. And like all things that are vital, and important, and life-supporting, and time-honored, it can be repaired. And it should be repaired.
For the thousands of people who have written us, to let us know how well Alpha Omega products worked for them, we are grateful. They chose, of their own volition, to use our product as a treatment. This was their choice.
However, the use of adjunctive products in such a way that it circumvents the realignment of the health care system so that it incorporates these products and other products like them, is not, in the aggregate, a healthy development.
It is a distinction we make not to conveniently skirt a legal minefield; it is a sensible position, based on common sense, the best scientific findings, and our own feeble attempt to inject a Socratic re-examination of a health care system that requires its citizens to repeat, at least once, some faint repetition of the Hippocratic Oath ...
It needs something more than repetition.
It needs to be lived.