The development of dietary supplements and nutraceutical products is usually based on published research data. As directed by the Federal Food, Drug and Cosmetic Act (FD&C, 21 U.S.C. 343[r]), manufacturers of dietary supplements should make only truthful and not misleading substantiation claims. The claim substantiation of supplement products should be based on human studies. These studies should be intervention studies that can provide causal evidence to substantiate the effect of the specific natural compound (ingredient). Observational studies have limited ability to provide causal evidence. Although animal and in vitro cell-based studies may confirm specific biological effects of ingredients, these studies are not enough for the proper claim substantiation.
It is obvious only effective ingredients can make an effective final product. However, the ingredient itself does not guarantee the activity/effectiveness of the final product. It is possible to find solid evidence in peer-reviewed studies about the effectiveness of certain ingredient(s), but in reality, final products on the market can be partially effective or ineffective.
Several factors influence the effectiveness of final products, such as formulation, reactivity of other compounds in the product and the delivery method. These affect bioavailability, which will eventually affect the product’s effectiveness.
Examples are the best way to explain the complexity of natural compounds’/ingredients’ effectiveness and ineffective final products. The large and growing popularity of cannabis and especially CBD is one such example.
Proper validation of biological activity is necessary not only for the original ingredients, but also for the final products. Only laboratory tests may identify active ingredients and confirm effectiveness of the final products. These activity validations of effectiveness should be applied not only for CBD products, but for all dietary supplements.
Read the complete version of this article in INSIDER’s Contract Labs digital magazine to learn more about the testing required to ensure products meet product claims.
Daniel Sliva, Ph.D., CEO & founder, DSTest Labs, is a senior investigator at Indiana University Health, and an adjunct associate professor at the Indiana University School of Medicine. He has master’s degrees in food and biochemical technology, as well as biochemistry, and a doctoral degree in molecular biology and genetics. Sliva also completed postdoctoral studies at the department of medical nutrition, Karolinska Institute, Sweden, and at the Indiana University School of Medicine, Indianapolis. He founded DSTest Laboratories at Purdue Research Park in 2014 for evaluating and standardizing efficacy of ingredients, nutraceuticals and dietary supplements. In addition to authoring more than 82 peer-reviewed papers and three book chapters, he is an international speaker.