Not having valid substantiation (or any research to support marketing claims) can be very costly. But research is confusing, which is why I think many companies skip this step entirely on their way to growing their businesses in the supplement industry. They seem to believe if they have a natural product that meets the definition of a dietary supplement, then it’s ok to skip the research process. This could not be further from the truth.
 
While there is a relatively low barrier to entry for getting into the sale of dietary supplements (relative to other markets, i.e., pharmaceuticals), the cost of doing business is likely much higher than anticipated by most companies. After all, there are local, state and federal laws to be considered. Further, if deciding to retail products in a store, through the Internet or through mail order, in addition to U.S. Postal laws, there may be others that can impact your business.
 
The logical method of obtaining sales is through various forms of advertising—which is inherently linked to research. In other words, when one advertises a product, state and federal laws dictate what you can and cannot say about your product or ingredient. In fact, these laws and a U.S. governmental agency (i.e., FTC) stipulate that products need the support of research in order for claims to be substantiated and not misleading.
 
What Level of Research is Necessary?
 
Once you are ready to retail your dietary supplement, understanding what you can say about the ingredient or product becomes of utmost importance. There are various types of claims that are regulated by FDA. These fall into three main categories: 1) nutrient content claims; 2) health claims; and 3) structure/function claims.
 
FDA’s Center for Food Safety and Applied Nutrition (CFSAN) supervises health claims. Currently, it has approved 12 of them.
 
FTC has authority over advertising and works with FDA in the space of dietary supplements. At a recent industry conference, Mary Engle of FTC stated the agency has been clear about what it looks for in order to decide whether a product is advertised appropriately. One aspect she discussed was substantiation.
 
Substantiation is when you have proof or the preponderance of proof that what you say about a product is true and not false or misleading. Ms. Engle stated that since 1984 FTC has been saying the level of science one needs for substantiation is two randomized, double-blind, placebo-controlled clinical trials.
 
More specifically, the agency states that adequate and well-controlled human clinical study “means a human clinical study conducted by persons qualified by training and experience to conduct such study. Such study shall be randomized, and, unless it can be demonstrated that blinding or placebo control cannot be effectively or ethically implemented given the nature of the intervention, shall be double-blind and placebo-controlled.”
 
If you want to engage in a research program and are not sure that funding a randomized, double-blind, placebo-controlled trial is the best use of your money, you might consider a “proof of concept” study.
 
Proof of concept studies typically utilize a pre-set amount of people, whereas a randomized, double-blind, placebo-controlled trial will utilize a more formal sample size calculation. 
 
The proof of concept study gives you a rough idea of the effects of the intervention while realizing this “rough idea of effect” is just that—so the results should be interpreted with some caution and not fully embraced as the end all. Importantly, did the product move the needle at all and in a meaningful way to be worthy of further development? The answer to this question will determine whether you move on to bigger trials.