October 7, 2019
Whether it’s an aging Boomer, an overworked Gen X weekend warrior or an active Millennial, maintenance joint health is increasingly a top daily concern. It’s a concern that spans generations and is driving consumers to seek out great information on natural solutions. Which raises the specter of the “E” in DSHEA.
That “E” stands for education. The concept behind the Dietary Supplement Health and Education Act of 1994 (DSHEA) was not only that dietary supplements were safe, but they are beneficial. That “E” stands for the opportunity to educate the consumer, and the law allows education to be available. Consider the critical discussion regarding claims for dietary supplements. That special allowance is present so that meaningful—as well as truthful and not misleading—educational information could be delivered to consumers.
Of course, there is a challenge with that when it comes to the topic of joint health. Even looking at this challenge from two widely different angles, the challenge is simple: Claims about joint health are tough to make. Add to this the desire to discuss the substantiated potential of some nutrients to affect minor pain and inflammation, but also the cost of such substantiation, and what we see in the market is more borrowed science that still doesn’t comply with the law.
FDA several years ago determined that inflammation claims were generally equivalent to disease claims, with few exceptions. When considering the limited potential for presenting acceptable pain relief claims and the preclusion of discussion of joint health, we have a claims quagmire. Substantiation alone for joint health support is challenging since most clinical endpoints would be either too long to measure realistically (populations with dietary components and statistically significant effect on joint health) and/or require evaluation of who would be considered “diseased” individuals. That substantiation, in FDA’s current thinking, is not appropriate.
However, I believe we can educate the consumer in those areas with the relative regulatory impunity; the emphasis in the approach lies in the “E” portion of the acronym and other allowances within the law.
One necessary component of compliance is the approach to presenting information on the label, in addition to considering the context surrounding presenting educational information. FDA’s interpretation of the “E” has resulted in marketers weaving words around the base of boundaries. Instead, by working within the confines of the law, without interpretation of the regulations, there is allowance for information to be given over to the consumer; but, this comes at a cost.
The requirement is that substantiation for claims—whether or not they are allowed—must exist in order to initiate the argument for acceptability of the claim from a regulatory perspective. This means evaluations in non-diseased individuals with clinical endpoints that are measurable and outcomes that meet statistical criteria. It isn’t easy, but the compliant presentation of meaningful information not only benefits the bottom line, but provides consumers with the information they deserve. Review of the claims and the substantiation behind them is the mandate plus the evaluation of a multitude of aspects regarding the balance of the information on the label.
The other angle of approach for consideration is widely divergent. Consider the fact that rheumatoid arthritis is a disease. No equivocation, no argument and entities that treat or prevent this disease or in any way affect the progression, outcome or other aspect are drugs. But what about osteoarthritis (OA)? What if the argument was that OA is simply a result of aging? Our bipedal physiology exerts enormous wear on specific joints. These joints wear out as a normal consequence of ageing and this non-disease crosses gender boundaries. Companies could therefore consider an approach that addresses the condition rather than the outcome. Provided the effects of the nutrient are substantiated in the matter of joint renewal, the discussion of another non-disease exists.
In this evolving landscape of structure/function claims, it is beneficial to stake out claims territory. The introduction of different approaches to lay claim to claims areas points directly to fulfilling the promise of DSHEA. Now is the time to push firmly against the boundaries of claims in order to clarify those boundaries, improve and standardize the level of substantiation and, most importantly, advance the “E”ducation of the consumer overall.
As chief operating officer, Jim Lassiter oversees all consulting operations at REJIMUS, formerly Ingredient Identity. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.
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