NDI Guidance Targets Modern Science, Innovation

When NDI submissions were first required, NDIs were supposed to be completely new compounds – often hybrids of nutrients – never before seen in nature in exactly that form. This always seemed a strange requirement since many safe nutrients are often combined with other safe, natural substances that help the mineral or vitamin’s absorption.

As the “decision tree” provided by the FDA with this latest guidance makes clear, if a new manufacturing process, extraction method, or plant part is used, then it is a new dietary ingredient!

This is absurd! This means that if hexane or other harsh solvents were used in the past, and safer solvents are used today that better preserve the integrity of the ingredients (e.g., grain alcohol or glycerin), then these solvents now render the ingredients as NDIs even though the extracts are closer to what’s growing in the soil than how it was extracted in 1993!

The guidance also states that synthetic versions of natural ingredients are also NDIs. What!?

 Virtually every product sold today includes synthesized, exactly bio-identical versions of what is found in a plant, nut, seed, fruit, or soil. By FDA's logic, most supplement ingredients and supplements containing them could eventually get their manufacturers slammed with notices of failure to submit a 75-day pre-market NDI notification, likely since most companies have been selling these ingredients and products for 17 years!

In addition, the safety testing requirements recommended for NDIs go way beyond anything reasonably required for herbal ingredients and nutrients. These over-the-top standards would not provide more safety; these would merely force companies to spend millions on unnecessary tests on ingredients that have been in the food supply for 10,000 years.

While this is not law, not regulation, and not binding . . . however, and this is a biggie . . . it gives a very clear picture of FDA's intent to use these side-door and back-door routes to undermine and effectively dismantle DSHEA, which protects our right to market and buy safe and effective dietary supplements.

If FDA were allowed to interpret the law this way, it would endanger thousands of products and scores of supplements, extracts, and tinctures. The ones that survived would be locked into pre-1994-era processing and manufacturing standards, and innovation would be almost totally blocked, since any new advances used with existing ingredients would require participation in the draconian NDI notification process.

We need to file a comment with the FDAtelling them to withdraw this notification as it is an outrageous, and unacceptable, approach to re-classifying hundreds, if not thousands, of safe dietary supplement ingredients. If you agree, let the FDA know that you will not stand for thisegregious attempt to roll back the clock on innovation by nearly 20 years, to grievously harm the health food industry and to set the stage for far less choice and cutting edge products going forward.