Don’t take it personally—Regulations are the same for everyone

“Personalizing” intake is among the most exciting and logical approaches to nutrition. Nothing is more personal than something a person puts inside their body, such as a food or dietary supplement. The challenge for food and supplement brands is to make them even more personal.

The industry is approaching personalization with vigor, but regulatory pitfalls face these enterprising brands. Personalization was not anticipated by those who made the regulations, but manufacturing and labeling must follow the same laws as the old, once-daily multivitamins.

Combinations of different supplements have been put together in packs for decades. These presentations take individual product formulas and combine them in packaging for specific needs. The evolution of this would be to tailor a series of supplements for the individual and package them specifically for that person. This goal is difficult to achieve logistically and is near impossible to do from the standpoint of the regulations.

Individual batch records are required for every lot of finished product. Each “personalized pack” requires its own individual batch record, along with the other regulatory documentation and testing. Individual containers of product must be released, since these constitute a single “batch.”

To make things even more complicated, brands could custom blend individual nutrition packets for consumers. Each of these individual blends requires a master manufacturing record (MMR) along with additional production documentation. The testing requirements would be increased significantly because the results of one customer’s product are not applicable to the next. The additional burden imposed on companies wishing to venture into this must be considered during the development of the business. Compliant mechanisms can mitigate these challenges, but many of these solutions undercut the purpose of personalization.

Multiple products providing different ingredients require “ad hoc” labels for each production, but all labels must still meet regulations. That’s fine when there are rolls and rolls of labels, but not so easy when they are printed on demand.

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