Ingredients suppliers and supplement manufacturers have filed comments with the Food and Drug Administration on FDA’s draft guidance on New Dietary Ingredients (NDIs). The comments that were filed in time to make the Dec. 2 deadline are almost unanimous in this respect: The guidance is severely flawed and should be withdrawn. FDA should start from scratch.
All this can be a bit arcane, with lawyers and longtime industry insiders wrangling over points of law that might make a rabbi cross-eyed. Who cares, right?
The big reason why natural products retailers should pay attention is that this guidance, if implemented in its current form, could cause many products to be pulled from shelves for relabeling and/or reformulation. At the extreme, some of these products could disappear if smaller manufacturers decide they can’t afford to comply with the new regs or, in the case of some niche products, a company decides that the sales don’t justify the cash outlay. End result: Fewer choices for your customers.
Here are a few ways in which the draft NDI guidance could affect your supplements aisle:
The draft guidance takes a very broad view of what might cause a so-called Old Dietary Ingredient, i.e. one that was on the market back when the Dietary Supplement Health and Education Act took effect in October 1994, to be considered chemically altered from that pre-DSHEA state and therefore be considered “new.” If a manufacturer changed the way they make an extract in one of the products in your store that product might have to go through a NDI filing, at a minimum cost of tens of thousands of dollars.
You probably have products on your shelves right now that contain synthetic versions of one or more molecules that were first discovered as parts of a plant. Lycopene in tomatoes or resveratrol in grapes, for example. FDA has said in the guidance that these synthetic versions cannot be dietary ingredients (even though synthetic versions of many vitamins have been on the market for decades). Industry sources are emphatic in saying that there is no scientifically defensible reason for this point of view. It seems that in the worst-case scenario those products would have to be taken off the market.
Costs of filing
FDA has taken the view that every supplement that contains a NDI needs to send in its own NDI filing, even if the ingredient in question had already been vetted for safety. Industry, needless to say, strongly disagrees and maintains the NDI process is about assessing the safety of ingredients, not of the formulations in which those ingredients appear. If the guidance is put into force in its present form, costs will rise dramatically and innovation, which is already on the wane, could be squelched further. Bottom line: Fewer choices and higher costs, all without providing products that are significantly safer.
Don’t like what you hear? Get involved. Talk to your congressman and join an industry association.