“It’s not personal—it’s strictly business.” — Michael Corleone
There is nothing more personal to a human being than a product that they put inside their body. That overarching perspective should guide anyone providing foods, dietary supplements or anything else that is ingested. Consider what these products are purported to be. Above all else, they are intended to be safe. The word “effective” isn’t in the description of what foods, inclusive of dietary supplements, can do. Nothing personal—it is simply a matter of how the regulations are structured.
Everyone is physiologically different. One from the other, we deal with food differently and our bodies have different requirements for the broad class of substances known as nutrients. It only makes sense that optimal individual nutritional benefit (note the lack of the term “effective”) would include a more personal evaluation of the individual with a specific eye to their nutritional needs. The reality is that the way the marketplace and regulations are structured, a sock-size approach is likely as close as one can come without significant regulatory and technological breakthrough.
An overarching philosophy to consider is that the more you know about yourself physiologically, the better you can be at maintaining that physiology. The approach to personalized nutrition builds on that. The results, thus far, are limited in many ways by the sock-size reality. Socks come is a limited number of sizes. Each spans across multiple foot sizes. Individuality in socks does not come in the size but in the appearance of the socks, and thus, it is truly a form-over-function selection. Obtaining information about a single individual through their physiologic makeup only sets the stage for the limitations. These are manifold, in that the variety of differences from one individual to another is so vast that literally personalizing someone’s nutrition is nowhere near precise. Hence the sock-size. The number of different “sizes” when it comes to food would be presented either in the form of dietary recommendations, potentially even to meal provision or supplemental nutrition, and food “tailored” to the individual. Just as with socks, the reality is that there is a finite number of variants that it is practical to target.
Recognition of this initial limitation is not necessarily something that should slow down the development of personalized nutrition strategies. The most common approach is to offer a variety through a mix and match process where individual components of the “personalized” nutrition package are selected from among a set number of options, which are algorithmically translated into the delivered product. This is not the only limitation. Once determinations are made regarding the nutritional needs of an individual, the task of compiling the components of the nutritional package must occur. Once compiled, they have to be processed, packaged and labeled. Here, once more, comes the complexity of concept but with the added wrinkle of regulatory requirement.
To use simple numbers, a hypothetical customer base is 100 people. They have been “sized” into one of 30 different nutritional needs summaries based on input directly from the consumer. The available food ingredients—or in the case of dietary supplements, dietary ingredients or even different dietary supplements to be combined—are finite in number as well, let’s keep that to 300. The computers have now chosen the combination of products to include in this personalized presentation. The problem initiates here. It is less challenging to deliver food in conventional form using this approach, but there remain regulations that must be complied with regarding the handling, processing, packaging and labeling of the product intended for the consumer. The critical number is no longer the number of potential ingredients (foods or nutrients) but rather the number of nutritional needs summaries. The larger the number, the greater the challenge. The challenge is really two-fold. Designing a process that will select from among the different ingredients the right amounts of the right ones is challenging. Equally as important is the labeling of the product. Since there are only 30 nutritional needs summaries in the scenario described, that is not very daunting, but simultaneously not terribly personalized.
Since dietary supplements are required to be manufactured in accordance with specific regulations, each batch size for each product produced must have a Master Manufacturing Record (MMR) and each batch produced must result in a completed Batch Production Record (BPR) that is a reflection of the information contained in the MMR. Still pretty straightforward with only 30 nutrient profiles and subsequent combinations of products. However, as the personalization increases and selection of different amounts of specific nutrients are chosen based on the individual’s nutritional profile, it is obvious how rapidly the numbers will overwhelm the ability to keep up with the demand.
The promise of personalized nutrition is one that holds a tremendous amount of appeal. The execution of the concept is where the regulatory and business needs meet the desires to provide the proper level of personalization. We are still at the very initial stages of understanding what personalized nutrition should look like, whether from a conventional food or dietary supplement perspective. We need to be mindful of what “personalization” truly means and be completely aware of the regulatory requirements that must be fulfilled in order to provide the product to the customer in a compliant fashion.
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.