By Cory Grand, PhD PMP
Walk into any pharmacy or grocery store personal care aisle, and you will be inundated by probiotics, diet aids, extracts, and herbal supplements.
Online and on television, these “nutraceuticals” are touted to provide benefits ranging from reversal of aging, digestive support, protection (or even treatment) of cancer, increased energy, “toxin” removal… one would be hard-pressed to name a health condition that is not purported to be treatable by one natural product or another. With all of this information, however, how does one separate the wheat from the chaff, so to speak?
Anecdotal evidence abounds; there are stories passed around of people who eschewed mainstream medicine for a particular supplement, and are now disease-free. Anecdotes are funny; George Burns enjoyed martinis, was hardly ever seen without a cigar in his mouth and lived to 100. Therefore, smoking and drinking leads to long life, right? Of course not. The latter does not necessarily follow the former. Simply put, anecdotes cannot stand alone as evidence.
Regulation for Natural Products
By way of reconciliation, I should point out that I am very much a natural product supporter; so many of our modern-day pharmaceutical agents are based on substances produced by plants, bacteria and fungi that I would be a colossal hypocrite to dismiss nutraceuticals out of hand. Salicylic acid (aspirin), quinine (an anti-malarial drug), and penicillin all have their origins in the natural world (willow bark, cinchona bark, and the Penicillum chrysogenum fungus, respectively). These products, however, have all undergone rigorous laboratory and clinical testing for safety and effectiveness before their acceptance into mainstream medical use. Nutraceuticals are not bound by this burden of proof, which makes it difficult to determine which claims are valid, and which are based on conjecture, anecdote, or at worst the silver tongue of contemporary “snake oil salesmen.”
This is not to say that there is no regulation whatsoever; the U.S. Food and Drug Administration requires that any dietary supplement be safe, either by limiting its ingredients to those “generally recognized as safe” or by proving that any New Dietary Ingredient is not toxic at the dose supplied. Natural product suppliers must register with the FDA and as of June 2010 abide by Current Good Manufacturing Practices (GMP), which include requirements for consistency in manufacture, record-keeping, and sterility.
However, no proof of efficacy is required; any claims made regarding such products must bear the following disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”. It is up to the consumer to determine if a product is effective… that said, nutraceuticals may make general health claims that do not strictly assert efficacy in a disease (for additional information, check out the FDA’s guidelines here).
While this does come with advantages in terms of cost to the consumer (the cost of bringing a nutraceutical to market is far less than a traditional pharmaceutical, which requires proof-of-concept laboratory studies, toxicity studies, clinical trials involving hundreds or thousands of patients to prove efficacy and superiority over standard-of-care, all of which must be recuperated once the product is approved for marketing), it creates an atmosphere of misinformation and confusion. This is especially dangerous today, as the internet makes it possible to disseminate information all over the world, without review or evidence (contrast this to the situation 25 years ago, when encyclopedias and professional journals, both rigorously peer-reviewed, were the primary source of scientific information).
The question, then, is how can a consumer determine the validity of these claims before deciding to buy a product?
By extension, how can a nutraceutical company earn the confidence of its customers?
Better Science Education
As science education becomes more refined and commonplace in earlier grades, the level of understanding of basic science has increased among the general populace. Concepts like genetics, physiology and health are taught in elementary school, resulting in a population of young consumers who are far more “science-savvy” than their parents or grandparents (as an example, the California Department of Education details their current standards for K-12 here).
In addition, these customers are taking a greater personal role in their health. As this trend continues, businesses must take this increased level of comprehension into account. I’ve recently come across a product which claims to combat aging through increasing telomere length by binding to the amino acids in DNA (paraphrased to avoid getting myself into some kind of defamation debacle). We hear about telomeres a lot these days, and their role in “cellular aging.” Amino acids and DNA are both biological terms… Those in my parents’ generation might read this and think that this product is legitimate. Those coming out of high school would probably realize that DNA does not contain amino acids, undermining any confidence they might have in the product. Sadly, it is the parents and grandparents who are dealing with health issues, and are being taken in by pseudo-scientific claims.
Good Data Creates Trust
Although nutraceuticals are not required to prove their efficacy, it is clear that, in a bloated market, any empirical evidence backing up a product’s claims would provide a competitive advantage. By “empirical evidence”, I refer to data collected experimentally to support a statement of effectiveness. This is distinct from theory (“since oxygen is important for living things, drinking oxygen-enriched water will make you healthier!”), which, although an important starting point, does not provide proof.
Anecdote (“I take this supplement every day, and I feel great!”) may simply be the result of a placebo effect, or have nothing to do with the product at all, and may not represent the overall population’s experience. A savvy customer must look for products which are tested in a laboratory or clinical setting, in systems which predict how those products will perform. A natural product which boasts its anti-inflammatory properties should be marketed alongside data showing that it reduces the expression of pro-inflammatory signalling proteins, for example. Armed with such information, a consumer can purchase and use a given nutraceutical product with confidence, and a producer can enjoy a much larger customer base and the revenues that come along with it.
For a nutraceutical company, this need not be a monumental investment; pharmaceuticals travel a long and expensive path from the laboratory to the manufacturer to the clinic before being approved, but for a natural product, several well-designed experiments can yield sufficient compelling data to support most claims. Given that such data would bolster consumer confidence, increase revenues, and ultimately legitimize natural products (which, because of pseudoscientific claims, unethical advertising, and misinformation, do not carry the trust they should), it is somewhat surprising that more nutraceutical companies do not employ controlled scientific methods during product development. I expect that this will change, as the global population becomes ever more well-versed in basic and applied science, and the nutraceutical industry as a whole is forced to meet an increased demand for evidence-based products. Those who do not, I believe, are ultimately destined to fail as the world moves on without them.