An NDIN is not an application for FDA approval. The notifier provides FDA with the information supporting its conclusion that the ingredient will reasonably be expected to be safe, and FDA evaluates whether that information provides an adequate basis for that conclusion.
FDA stated that it was unable to establish the identity of the proposed NDI based on the information provided in the notification. The agency identified inadequate information concerning the botanical starting materials, manufacturing process and analytical testing.
FDA also stated that it was unable to establish the safety of the proposed NDI based on the information provided.
Specifically, FDA said the notification contained inadequate evidence establishing the relationship between the test articles relied upon as safety evidence and the proposed NDI.
FDA ultimately concluded that the submission:
"does not provide an adequate basis"
to conclude that the proposed 75% mitragynine extract would reasonably be expected to be safe under the proposed conditions of use.
FDA further stated that a product containing the NDI "may be adulterated" under 21 U.S.C. §342(f)(1)(B), and that:
"Introduction of such a product into interstate commerce is prohibited under 21 U.S.C. § 331(a) and (v)."
After publication, TNT Manufacturing President Todd Underwood contacted us and objected to several characterizations of FDA's response.
Underwood emphasized two distinctions that deserve to be clear.
First, FDA said a product containing the NDI "may be adulterated." The letter did not state that FDA had made a final determination declaring a particular product adulterated.
Second, Underwood noted that FDA did not affirmatively determine that the 75% mitragynine extract itself was unsafe. Rather, FDA found that the information submitted did not provide an adequate basis to conclude that the NDI would reasonably be expected to be safe under its proposed conditions of use.
We agree those distinctions matter and have revised this article accordingly.
There is no need to characterize FDA's response more broadly than the agency did.
The record establishes that FDA was unable to establish the proposed NDI's identity or safety based on the information submitted, and concluded that the submission did not provide an adequate basis to conclude that the NDI would reasonably be expected to be safe.
FDA further stated that a product containing the NDI "may be adulterated" and that introduction of such a product into interstate commerce "is prohibited."
Those statements appear in FDA's November 26, 2024 response to NDIN 1361.
Readers can review the complete notification and FDA response and draw their own conclusions.
The TNT Manufacturing NDI notification and the FDA response. Download them and share with legislators, advocates, and the public.
FDA Response to NDI Notification No. 1361 — the complete regulatory record.