Products promoting energy boost are defined by nutritive valueProducts promoting energy boost are defined by nutritive value
Regulatory compliance depends on ingredient claims, and those in the energy space are confronted with numerous wrinkles.
July 2, 2020
Everyone needs a boost. It doesn’t matter if you are an office or factory worker or if you are a weekend or weeknight athlete. The idea of having more energy is appealing to everyone. With all that need for additional energy out there, the market is craving products that have positive effects on energy. Looking at the topic of energy, there are some interesting situations that have developed over time. Energy is considered part of the definition of “nutritive value.” This is important for the basic understanding of what energy claims may be made and why. The regulations further describe how energy can be labeled, as 21 CFR §101.9(c)(1) is the only labeling description of energy and centers on calories.
The acceptance of substances other than those that do not provide calories, but still provide energy, is not firm. The importance lies in the definition of “nutritive value.” Since energy is considered nutritive value, provision of it allows for claims to be made concerning the effects of a food product on the structure, or in this case function (providing energy) to the human body. This is the allowance for foods in conventional form to make such claims—it must be based on the nutritive value of the food. Absent that demonstration, there is no structure/function claim to be made.
The specific allowance for claims regarding energy contained in food products that provide caffeine in one form or another is clear within the regulatory actions taken and the current labeling practices for these products. The science behind whether caffeine actually provides energy is a little less than supportive, but regulatory inaction is a clear indication. Secondary considerations abound in the realm of B vitamins. The documented mechanism of action for many of these ingredients includes their role in energy production. This does not mean B vitamins provide energy, but they do help convert dietary energy into ATP (adenosine triphosphate), the kind of energy your body uses. Those are the two simplest presentations of the seeming conundrum behind what does and does not provide energy.
There are other substances in the marketplace that purport to provide energy in some form or another. Sometimes the type of energy is identified as “sustained” or “long-lasting.” As with any structure/function claim, there is a requirement for substantiation of the claim to exist. This means that both the provision of energy or the boost in energy production, or whatever form the claim takes, must be substantiated. But more importantly, the modifier words similarly need to be substantiated. Consider what long-lasting is? Does the information substantiating the claim demonstrate an extended period of time? Is that time period significantly longer than simple caloric intake? Important questions to answer.
The lingering issues that remain involve the overconsumption of at least one of these energy givers—caffeine. Products that are labeled as foods are not required to disclose the amount of caffeine in a serving, and this raises previous concerns over potential overconsumption of this energy-boosting ingredient. Other substances are purported to boost cellular energy but there remains a paucity of research concerning whether ingredients like creatine monohydrate or L-carnitine provide any sort of quick boost of energy. While the evidence does point to these compounds promoting energy or being involved in energy production, care in the creation of the claims to match the substantiation must be considered.
The last consideration involves consumer awareness and perception. It is no longer as simple as telling the consumer that the product refuels you (a classic claim for sugared drinks with sprinklings of electrolytes) or that the product gives you the energy you need. There is an increasing number of consumers who have awareness of the functional benefits of some of these compounds on their own and recognize them. The presentation of the claims for them and the inclusion of them in formulations must consider all aspects of the claims intended, the products intended and the substantiation in support of the claims. Simultaneously, the relative safety of each of these components used must also be considered and the attendant marketing associated with the products should also not remotely overpromote consumption.
The marketplace for energy drinks is broad. The discussion of food products and supplements that provide or enhance energy production is one that has serious legitimacy. The descriptors for the claims, the quantitation of the individual components used in the products and the consideration of the knowledge level of the marketplace all are necessary components to successful promotion of these products without the regulatory risk.
Jim Lassiter, chief operating officer, 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 products industries.
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