FDA: L-Theanine Powder Supports Relaxation Claim

This document is a notice from the FDA regarding a submission for a dietary supplement claim related to L-Theanine Powder. The submission, from Threshold Enterprises (Source Naturals), pertains to their product, Serene Science L-Theanine Powder, which is marketed with claims of supporting relaxation and easing normal everyday stress. The FDA's receipt of this submission is noted, but no specific regulatory action or review outcome is detailed.

Regulated entities, particularly manufacturers of dietary supplements, should be aware of such submissions as they relate to the types of claims being made for products. While this notice does not impose new obligations or require immediate action, it serves as an indicator of products and claims entering the regulatory landscape. Companies making similar claims should ensure their substantiation is robust and compliant with FDA regulations.