Ash. Dun. Slate. Roan. Plumbaceous.
Whatever shade of gray you prefer to describe the unique regulatory niche dietary supplements have carved out between the immovable dolmens of food and medicine, suffice it to say that this gray space is getting grayer. Though regulated as a subset of food, shifting consumer interest toward non-pharmaceutical solutions to health conditions has pulled dietary supplement marketing in line with that of the over-the-counter drug market, which then prompts companies to push the boundaries of DSHEA compliance when it comes to their health claims.
Business changes faster than the rules do—any bureaucrat can tell you that. The OTC-ing of the supplement industry has been on the advance since the advent of DSHEA in 1994. Today, another force is starting to tug on the supplement industry's orbit and pull it into the gray zone—personalization. Nutrition Business Journal can't stop talking about the promise of personalized medicine as it filters into the supplement space—see, for example, blood diagnostics democratizer WellnessFX, winner of NBJ's 2012 Innovation Award. Diagnostics and genetics are now the bleeding edge of nutrition.
The mapping of the human genome a decade ago served as a nodal event for changes in healthcare—an epicenter from which genetics has gradually tumbled into an array of industries: sequencing hardware, big data, clinical diagnostics and now consumer nutrition. Supplement companies have just started to scratch the surface here. For one, there's geneMe, which sells cheek-swab kits and formulates nutrient combos based off a 12-gene sequence. And now weight loss is on board too! Amway's BodyKey by Nutrilite weight-loss program now offers a genetic test, in cooperation with InterleukinGenetics, to determine the ideal fat-carb-protein ratio for your diet, and yours alone. Cool, no?
But as promising as these personalized approaches may be, they begin to lead us into a food/medicine gray area—and FDA hates gray areas. Take the Ideal Omega Test Kit from Barlean's. It's a take-home blood test (read: medical device) that quantifies the omega-3 to omega-6 ratio of fatty acids in your body. Once you mail in the sample, your analysis is returned with "detailed dietary and supplemental suggestions" to better balance your fatty-acid profile. And it's available at retail. Intriguing? Certainly. But careful language aside, this confluence of devices, diagnostics and recommendations (prescriptions?) leads up to one inevitable, awkward question: Isn't this just medicine? – Connor Link