The Coming NDI Draft Guidance Enforcement Discretion

The Coming NDI Draft Guidance Enforcement Discretion 

Friday, June 17, 2022
Written by: Jim Lassiter

So the other regulatory shoe is about to drop, with the issuance of recent news from the FDA, regarding the current NDI Draft Guidance and FDA’s intention to exercise enforcement discretion for the “thousands” of New Dietary Ingredients that FDA is certain are out in the marketplace without proper notification. What does that all really mean? 

It means a lot. The topic of these notifications has been hiding in the background since the passage of DSHEA in 1994. Now, the FDA is essentially placing shots across the industry bow, by announcing that it will act against those products using New Dietary Ingredients (NDI’s) that have not been notified. Which ones? Well – that is where the guessing game begins. The response is known to no one, except for the FDA really, and they will make up their mind presumably as soon as the current draft guidance is finalized, but then again maybe not. Remember the one published in 2016 concerning New Dietary Ingredient Notifications? Yep, that’s the one. If you have forgotten what it is or looks like – just take a peek to get refreshed despite first efforts and it sitting in draft form for almost the past 6 years, hovering like the sword of Damocles over the industry’s head. This discretion applies to New Dietary Ingredients requiring notification to be specific. The enforcement discretion period begins within 180 days of publication of the final guidance. Those products marketed on May 20, 2022, without the required notification will be the subject of enforcement action. 

The open questions in all of this include some critical ones. There is the matter of differing botanical extracts and what truly makes these individually different and thus subject to the notification. Another question that has been “answered” on numerous occasions but involves whether a phytochemical that is manufactured/synthesized without the use of a starting food ingredient (botanical or otherwise) can even be considered a Dietary Ingredient at all. The clear indications are that NO – they are not. While this would ordinarily involve some form of rulemaking, FDA’s position is clear and will be enforced. 

Lastly is the matter of other regulatory requirements that will be swept up with the notification – a process that FDA openly admits it will NOT complete within the original statutory timeframe of 75 days for market introduction until FDA gets around to it. So the sword continues to hang. Developing an ingredient to bring to market only to have the regulatory agency potentially rule it out of existence, even with the proper notification, is generally not a positive for business.  

Companies need to conform to the applicable regulations. That is what we are all about. However, it is another matter when the rules of the process change, or rather continue to do so after the finalization of the guidance (so not new regulation since that has been written), which puts business owners at potential regulatory risk. Even more of concern and contention is the request in the new Draft Guidance that companies submit a hypothetical finished product label for a Dietary Supplement to be sold using the NDI along with any reports of adverse events or serious adverse events so they may better be able to make proper determinations as to the safety of the ingredient or supplement, while combing through the label to find any other issues with other regulations. Many clients only intend to manufacture ingredients and have not control over what their customers put in their products, the levels or even what is on their labels, but yet we still conform. 

In fairness, industry has brought this about with its own inconsistent approach to complying with the notification requirements out of 21 CFR §190.6 since that regulation was finalized. The result is a de facto approval system for those products that have been marketed (past tense) offers additional information than required if the company had notified the ingredient as originally required by the Law. All the while simultaneously attempting to conform with the current and evolving thinking about these ingredients and their overall regulatory status. Accepting these requirements and proceeding to assist FDA with its job is not a position without merit. It is, however, not remotely what DSHEA was supposed to fix. It is quite the opposite. 

Simply put, we are fully in favor of and have worked hard with our clients in order to make compliance a matter of course in all these activities. That said, we are also fully in favor of actual regulation (like you know the ones that already exist) and enforcement actions taken against those who do not. Without resolving some or even any of the challenges with the matter of Dietary Ingredients generally, industry is being asked to undo DSHEA (remember that Dietary Ingredients are not subject to Food Additive regulations) under the guise of consumer safety. Once more, the industry as a whole has brought this on themselves and regardless of the number of NDIs that have not been properly notified, this form of “cooperation” with the regulatory agency poses no appreciable benefit to the consumer and will only serve to further restrict the provision of safe, meaningful and beneficial products being made available. 

In the meantime, ingredient companies, especially those with novel compounds or manufacturing processes that haven’t notified or even assessed if they need to notify, need to start preparing immediately for what may come a rapid impediment to their future business in an already ready economically tumultuous period of time.