“Worry and stress affects the circulation, the heart, the glands, the whole nervous system, and profoundly affects heart action.”
—Charles W. Mayo, M.D.
A good night’s sleep is beneficial and desired by just about everyone. Sleep is a topic that people naturally warm to. Linked are things that prevent this respite from each day—usually a discussion of stress. All consumers deal with stress, and sometimes it gets in the way of night’s precious escape. Remedies of all sorts are offered to help people get the sleep they need and desire.
Industry is scattered with a number of sleep aids included in product portfolios. This product category is one that percolates along without much fanfare since the “usual suspects” are typically not involved with these formulations. However, additive to these are the components known as adaptogens. These beneficial components are increasingly recognized for their effects and benefits, but does the use of them meet regulatory requirements?
Adaptogens are substances that assist the body in adapting to stress by countering its effects on the human system. Measurement of stress reduction is far more challenging than demonstration of sleep assistance. The melding of the two areas of interest and seemingly providing cover for claims associated with stress as a contributor to sleeplessness is logical, but the demonstration of the adaptogenic effect is the issue. The definition of the term itself is rather broad in the sense there is no definitive demonstration of these benefits to the degree necessary to show the effects most directly. Simply asking any knowledgeable herbalist or natural medicine practitioner will result in a discourse of experience, tradition and discussion of the different adaptogens’ individual purposes. The discussion usually continues to the point of explaining different adaptogens are purposeful for different situations and individuals. The adaptive effect of the compound needs to be demonstrated in order to have the substantiation necessary to make the claim. Compositional challenges arise as well when the adaptogen determined to be of use is one that does not fit neatly into the regulatory scheme. These compositional challenges are equally fraught with potential regulatory issues in the promotion of products, which are of enough concern to stress out over, unfortunately.
Managing stress through the consumption of any substance is historic in the United States. The first compounds historically sold for stress management were B vitamins. Water-soluble B vitamins in elevated potencies are products that still identify as “stress vitamins” today. This carried forward the understanding that these vitamins were lost more rapidly under times of stress and, hence, the replenishment strategy. Today’s array of products designed to help with stress management includes far more compounds than simply B vitamins. Whether B vitamins for stress or adaptogens assist with coping by supporting the systems effected by stress, the same evaluation remains: Does the ingredient or ingredients or, better still, the specific product, have sufficient substantiation to talk about stress management? This begs the question, how is this measured? The evaluation of the clinical endpoints that must be measured in determination of stress management are not easy to identify. Yet, the quality of the substantiation depends on a demonstration of substance benefits relating to physiologic systems affected by stress, rather than direct combat of stress itself.
Sleep is a different matter. The array of natural products intended to address sleep troubles rely on the same fundamental concepts of relaxation and the physical systems that trigger a relaxed state to allow for sleep. Stress reduction and sleep are hand-in-glove-type issues, but these claims again—yes, these ever-pesky claims—may present regulatory risks. While a product may legitimately offer something for occasional sleeplessness, it cannot discuss insomnia. While a product may assist in coping with stress, it cannot discuss PTSD (post-traumatic stress syndrome) or many of the consequences associated with stress owing to the context evaluation of the label. A product’s ability to promote sleep differs from the role of adaptogens, but the topics remain closely related. The requirements to demonstrate sleep benefits are the same as for all substantiation, but are more simply performed.
The most significant, common challenge with developing products and adaptogens is the final composition in which they are presented to consumers. FDA has already formally moved against synthetic versions of phytochemicals by determining they are not considered old dietary ingredients, let alone whether they’re considered dietary ingredients at all. This challenges the acceptability of the compounds themselves. Therefore, the first determination to be made is whether the substance requires notification through the new dietary ingredient (NDI) notification process or through a food additive petition process (i.e., GRAS self-determination, food additive petition).
When considering the range of adaptogens and other potential substances to use in a product, consider first, hurdles may exist simply in selection of the substance to ensure the resulting product does not run afoul of regulations. Then comes the daunting task of ensuring the copy describing the wonders of the product are allowable and, finally, the demonstration that the described benefits are adequately substantiated—not simply referencing unqualified studies. Each of these requirements is challenging and must be addressed each time a product is conceived. Otherwise, sleepless nights are likely in store and the stresses involved require more than simply adapting; preparation in advance of product delivery is the stress relief that is most effective.
As chief operating officer, Jim Lassiter oversees all consulting operations at 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.