NDI Delay is Ominous for Industry

The past few weeks have seen the dietary supplement industry under close scrutiny yet again both in Washington and in the media. On May 26, regulators, legislators, industry and consumer groups went in front of the Senate Special Committee on Aging in an attack entitled, “Dietary Supplements: What Seniors Need To Know” , and most of us have heard the results: that some retailers are telling tall (illegal) tales about what supplements can do, and that many supplements are ‘contaminated’. Incidentally, an article yesterday’s USA Today tees off on this very issue with an intro paragraph that reads enticingly, “Next time you're taking a dose of your favorite dietary supplement or herbal remedy, how would you like a dash of lead on the side?” At least that article, unlike a weekend NPR radio report, allows CRN’s Steve Mister some counterpoint to defend the sector.

The USA Today article includes a single reference to what might in fact be the most defining and important Pandora’s box facing the industry, namely, the lack of an approved list of ingredients. That critical point was also referenced in testimony a few weeks ago by Dr. Joshua Sharfstein, current Principal Deputy Commissioner of the. In this case, both the choice of language and comments not made are significant. Sharfstein testified, “There is no authoritative list of ingredients that were marketed prior to 1994, which creates a significant challenge to FDA in enforcing this provision of (DSHEA).” USA Today’s take was, “Proposals to restrict supplements to ingredients approved by the FDA have already drawn fierce opposition…”

Word earlier in the year suggested that the long awaited New Dietary Ingredient (NDI) guidance document from FDA was at most weeks away from release. In his testimony a couple weeks ago, Sharfstein said the agency expected “this guidance document to be ready by the end of this year.” At best, the delay is curious. At worst, it signals a harsher stance that could turn to a trickle the number of ingredients entering the market year on year.

The real ominous cloud though, looms squarely over the hundreds (thousands really, depending on definition) of ingredients that have been either introduced, or altered, since the passage of DSHEA 16 years ago. With the GAO, mainstream media and the sports community block moving in lock-step to condemn the lack of an approved list of ingredients, we can certainly expect this guidance document to be harshly restrictive. Quite likely any alteration to an original substance will constitute the creation of a new dietary ingredient.

I can only hope that companies are scrambling to find documentation of pre-1994 use, as well as to show that any process changes introduced since then have not changed fundamental ingredient characteristics and properties and moreover, have been proven safe. And once again, onus is on the ingredient manufacturer once again to do the homework for the industry. Maybe this time, we’ll see full appreciation and credit given to those companies that work the hardest to support their supplement company clients, instead of the all too frequent commoditization that typically cheapens the sector.

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