What Are New Dietary Ingredients (NDIs)?
What does the dietary supplement industry love more than anything?
If there’s a way to shorten, abbreviate, or otherwise truncate a term or phrase, this industry has figured it out. Of all the abbreviations that the nutraceutical industry likes to use on a regular basis, few have led to more conversations and discussions than NDI.
Short for “new dietary ingredient,” this acronym has a 20-year history of inducing head-scratching while also safeguarding consumer wellbeing.
The Million Dollar Question: What are NDIs?
Fact: Prior to October 1994 the phrase “new dietary ingredient” (and the subsequent acronym) didn’t exist.
So what happened in October of 1994? The dietary supplement world was introduced to another acronym! DSHEA, which is short for the “Dietary Supplement Health and Education Act,” was signed into existence on October 25th, 1994. With DSHEA came the “new dietary ingredient.”
DSHEA and the NDI
For the sake of understanding NDIs, here’s what you need to know about DSHEA:
The Dietary Supplement and Health Act of 1994: Under the terms of this federal act, the dietary supplement industry falls under the jurisdiction of the FDA. Accordingly, the FDA is responsible for establishing the Good Manufacturing Practices (see 21 CFR Part 111) that regulate the industry.
As part of DSHEA, it was decided that supplement manufacturers would not need to seek FDA approval in order to market supplements and supplement ingredients that had been present in the US market prior to 1994.
Any supplement or supplement ingredients introduced to the US market after 1994 would have to be submitted to the FDA for review for safety and efficacy as “new dietary ingredient.”
Prior to August 2016, the standards for submitting NDIs to the FDA outlined established in 1994 had remained unchanged.
Your Supplement Product and NDIs
Even though your contract manufacturer should be able to provide you with plenty of information when it comes to understanding NDIs and what implications there may be for your supplement product, the FDA has tons of educational material on the subject.
We recommend taking a look at their “New Dietary Ingredients In Dietary Supplements – Background for the Industry” page. They offer up answers to key questions like these:
- What is a new dietary ingredient?
- When must you notify us about a new dietary ingredient?
- What information must the notification contain?
- Where do you send your premarket notification and who do you contact at FDA, if you have questions?
- What happens after you submit a premarket notification for a new dietary ingredient to us?
- What new dietary ingredient notifications FDA has received and what is the status of each?
If you still find yourself confused by the mention of this pesky little acronym, our team of production specialists and account managers is always willing to help brand owners work through any contract manufacturing questions they might have.
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