The Looming Future of NDI’s

NDI Draft Guidance Image

The Looming Future of NDI’s

Wednesday, February 15, 2023
Written by: Jim Lassiter

There is always a common thread in considering the possibilities and future of regulatory matters when it comes to the food and dietary supplement industries. That commonality equates to an ever-tightening noose for just about every aspect of the requirements for compliance. Unfortunately, this is often put in place without the benefit of a rulemaking process and is therefore, less than definitive and questionably enforceable for that matter. Still we, folks in the industry, have to deal with it. Such is the case for New Dietary Ingredients. Without additional caveat – here’s a prediction as to what we can see this year…

The 2016 Draft Guidance for New Dietary Ingredient Notifications (NDINs) was identified as the “the most current thinking” of FDA on this matter along with the recent clarification update published last year. While it contains non-binding recommendations, the clear intent is to define what is expected for such notifications. The process itself is not overwhelming – but the “noose” is already starting to tighten and effects are being felt. To refresh the memory: FDA’s view is that any DIETARY SUPPLEMENT using a New Dietary Ingredient must notify the FDA of such use. Since this is already the expectation, it is likely that soon, the FDA is going to start requesting NDI Dossiers from brand owners and/or ingredient companies to determine if they in fact require a notification even prior to finalizing the NDIN Guidance this year. However, in practice to date, it has been only ingredient suppliers performing the notifications or NDI Dossier assembles. Recognition of the intent of the Law as modified was designed to ensure notification and review of any New Dietary Ingredients rather than the use of such materials. The elimination of the “finished product” notification requirement,would be a good step in shoring up the supply chain and holding more companies accountable earlier on where they should be. This notification accomplishes the desires of the legislative intent – exempting dietary ingredients from food additive requirements but mandating notification of New Dietary Ingredients – to the fullest. The listing of dietary supplements using these ingredients makes no sense in the construct of the Law and its allowances and intent.

Well, whether a specific NDI requires notification or not, the NDI Dossier (DO NOT call them “Master Files” any longer) must exist on file and be available upon inspector request. Also, companies solely reliant on GRAS Status (especially Self-affirmed ones) aren’t going to be safe from this active interpretation if they are making or marketing dietary supplements. For those lacking anything or having inadequate info on file, would theoretically, result in an enforcement action against the company with the unnotified Dietary Supplement using the questionable NDI, or even the ingredient supplier directly, but how practical is this really? Uneven enforcement from the Agency is a never-ending thorn owing to largely limited resources and the bureaucracy that exists. How could the Agency make up for this deficit quickly though? Well, fines of course, big ones, and then hire and train more inspectors/reviewers to deal with the backlog. Then the application of the existing regulations targeting a large ingredient company or brand that is marketing or selling a non-compliant or suspicious ingredient,  they can shock-start things and make an example or two for the rest of the industry. This is certain to occur in the foreseeable future as it has been common practice in the past.

Secondary to this activity is the increasing scrutiny of the submissions and FDA’s not-infrequent ruling that a notified substance does not qualify as a Dietary Ingredient at all. The increase in actions such as this is very likely to occur during the coming months and the answer to this, you need to be prepared with an argument to the contrary immediately. The most recent example of N-Acetyl Cysteine (NAC) shows the direction FDA wishes to move, but similarly, the current stalemate regarding its removal from the market and potential opposition to such restriction. FDA’s principle mandate is to ensure the safety of the food supply, not concern itself with the most obscure exclusion criteria – as the NAC debacle points out.

Not yet addressed, but coming soon to a regulatory action near you, are other issues such as the very different “extracts” of botanicals that exist, the differences resulting in additional NDI requirements. Plus there is the lingering question of demonstration of chemical equivalence of the synthetic forms of a given phytochemical and its consideration as a Dietary Ingredient. There are many more matters looming given the increase in synthesis and biosynthesis technologies becoming more prevalent for food ingredients in the marketplace with continued efforts towards somewhat more “sustainable” or more “environmentally friendly” or more “geno-custom” alternative ingredients and thus the alternative foods they will become. There’s still a great deal of subjectivity here of course, so stay tuned.