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Discerning high quality research evidence from speculation and marketing hype is more important in today’s climate.
September 8, 2020
By: Gregory Stephens
By: Sheila Campbell
When the Dietary Supplement Health and Education Act (DSHEA) was unanimously passed by Congress in 1994, the industry and healthcare professionals cheered. At that time, dietary supplement labeling was not tightly regulated. For many products, consumers could not verify the contents with a high level of confidence. Truly, some contained contaminants, and some did not contain the promoted ingredient as stated. There were no uniform manufacturing standards governing product safety and purity. And some products were marketed based solely on their “story.” For example, the ingredient was found in a remote region of the world being used by the indigenous people who lived into their 100s with no evidence of disease. Little or no scientific substantiation was given, or asked for. A good story is still important. But from our perspective, a robust promotional narrative was often more relevant in certain distribution channels than others. For example, health food stores, multi-level marketing, and some e-commerce sites benefited more from emphasis on the story compared to products distributed in the health practitioner channel. Practitioners and their patients were less interested in the marketing and more attuned to clinical research supporting efficacy of claims. But times are changing. First, DSHEA mandates that manufacturers and distributors of dietary supplements and dietary ingredients ensure that products are not adulterated or misbranded. Firms must evaluate the safety and labeling of their products before marketing to ensure that they meet the requirements of DSHEA. The FDA can and is taking action against companies marketing adulterated or misbranded products. Second, although it is cliché to point out that today’s consumers are savvy, it is a fact. More often than not, they ask for evidence that a product actually does what marketing claims. Enhancing their knowledge, more consumers are asking their healthcare providers for guidance, and practitioners are incorporating the use of dietary supplements into patient care plans. But healthcare professionals will not make recommendations without data. Third, the COVID-19 pandemic has changed the world. Global experts call for scientific data from well-designed studies, and world leaders echo the need for scientifically based evidence to direct the fight against the virus. No doubt, this requirement affects the dietary supplement industry operations at every level. Hierarchy of Evidence The “gold standard” for claims support is the prospective, randomized, controlled clinical trial (PRCT). However, trials of this type may not always be possible, practical, or ethical. Other evidence, including in vitro and animal studies, as well as expert consensus opinion, adds to the evidence that can be used to support claims. The strongest evidence comes from systematic reviews, meta-analyses and PRCT (see Figure 1). Descriptive, observational reports such as case studies and anecdotal reports provide weaker evidence because their design is not controlled, and data cannot be applied to populations other than the specific one included in the study. Expert opinion provides the weakest support. FIGURE 1. Hierarchy of Scientific Evidence
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