Sports nutrition is at the cutting edge of nutritional support and physiologic enhancement. It is also at the confluence of just about every challenging regulatory topic facing the industry. Sports nutrition brands often reference more science during formulation than other companies. This category is poised to push the industry into territory it has not been.
Two major arteries feed into this confluence of potential regulatory challenges. The first is centered on labeling. Are the claims made acceptable? Likely yes, owing to the caution that most players in this space take. These claims are typically presented in terms that are difficult to pin down using hyperbolic language to present information about how to get “ripped” or “shredded.” However, more specific claims wander into unacceptable territory. This most often shows up in terms of how much better one product is than another or the reason the product yields the results promised.
Formulators of sports nutrition products include some of the more inventive minds in the industry. They monitor science to determine trends and innovations. Ingredients and delivery forms in this category often come with a good bit of documentation of effects, which serves well for fulfilling the claim substantiation requirements. However, one lingering problem is the use of “common or usual names.”
Per the Federal Food, Drug and Cosmetic Act (FD&C, 21 CFR 101), supplement brands must include the statement of identity of a food (including dietary supplements)or, if no such name is specified, the common or usual name of the food. If the food has no common or usual name and the nature of the food is not obvious, the statement of identity must be an appropriately descriptive term.
A chemist would delight in the description of the dietary ingredients offered in this category. Those delights are not necessarily in alignment with the “common or usual name” requirement. They may not even be the preferred chemical name for the component. This shortfall leads into the next river of challenge regarding the ingredients themselves.
Not that long ago, chemical names abounded on sports nutrition labels as ingredients. Apart from the nomenclature challenges, brands must determine whether these materials are authorized for use and inclusion in food products (including dietary supplements). The limitations put in place by the Anabolic Steroid Control Act of 2004 and the Designer Anabolic Steroid Control Act of 2014 removed several ingredients from the market. Some ingredients still exist in a regulatory limbo.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) says dietary ingredients are exempt from food additive regulations. However, there is a statutorily mandated notification requirement when those dietary ingredients are determined to be “new.” The science that supports ingredient efficacy and subsequent development of components that have an effect does not eliminate the obligation to notify, at a minimum, the use of these components if they are new. Failure to do so results in the introduction of adulterated product into the U.S. market, which is not a good place to be.
Sports nutrition advocates and devotees focus on the potential to achieve individual dreams regarding appearance, stamina, performance and mental clarity. The information presented to consumers is voluminous. Studies are cited and formulations with the latest and greatest ingredients are put into the marketplace routinely. No abnormal regulatory action is taken in this category, and brands that face legal prosecution are often due to “undeclared” ingredients.
Ingredients’ desired effects and the insider knowledge of what “works” is shared among the sports nutrition advocates far more readily than the average consumer. The challenges begin when the labeling of these products and their formulations are scrutinized. The suppliers of sports nutrition products should be aware of the crossroads at which they sit and be prepared when the regulatory inquiries come.
Learn more about this category’s potential in INSIDER’s “Sports nutrition: Muscle building” digital magazine.
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.