Nutrition Business Journal

Letter From NBJ: Right Or Responsibility?

A year ago, I wrote that condition specific was the space where supplements retain a right to win. A public convinced, often mistakenly, that their cart full of Whole Foods Market produce is going to satisfy their every nutrient need might be less eager to spend money on a multivitamin (something borne out in NBJ sales data) but at the condition level they are unlikely to buy an avocado for joint pain.

A year later that’s still true. It’s just more complicated and, possibly, hopefully, more lucrative.

The consumers didn’t change their minds.

Regulators changed the game.

Two weeks ago, the FDA’s revised NDI guidance came out, and tucked into the 100+ pages are some paragraphs that innovators in the condition specific space will undoubtedly appreciate: master files that establish what a new ingredient is and how it’s manufactured. These files could also establish a patent-level protection for the intellectual property behind the ingredient.

If it’s enforced, that creates an unprecedented incentive for innovation. If it’s enforced, the age of the knock-off ingredient could be over. Of course, the “if” of enforcement has been echoing across the industry since the early days of post-DSHEA, but even if the enforcement doesn’t protect every branded ingredient from every unscrupulous vendor, it could push product developers to a level of rigor that raises the bar for the industry and the value for the consumer.

Condition specific is a space where, by definition, much of the NDI action is likely to occur. Companies going through the expense of the NDI process will likely be damn sure that the science supports the product.
Better ingredients formulated on better science? Upping the game and raising the expectations could be good for the industry as a whole. Consumers who discover products that work are likely to take a new look at offerings across the industry, from the latest branded ingredient to the most basic of the letter vitamins.

Is that the naïve scenario? Probably. Is it a scenario everybody should be working toward? Definitely.

The right to win I wrote about last year comes paired with responsibility. The NDI process is going to be expensive. It will take safety testing that many in the industry will undoubtedly grumble at, but it’s the kind of expense and diligence that the public expects. In consumer research earlier this year, NBJ found troubling news about trust in supplements—the industry ranked just two rungs up from Congress for trustworthiness—but one of the brighter notes was that people believe the industry is trying. More than two-thirds, 68 percent, believe the industry is continuously working to make products more effective.

It’s a belief the industry should live up to, and the NDI guidance is a strong nudge in that direction.

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