Regulatory Open Forum

We are new as a company to Dietary Supplements (US market), what are the guidance's/Regs for labeling and SPL submission requirements, we want to make sure we don't miss anything

We are being told that there is no requirement for an SPL as there is no ANDA or monograph required for this product?

Many thanks

Hi there, the FDA has guidelines for labeling and marketing dietary supplements.  See link below:
https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide

You are right that there is no need for a SPL or ANDA or monograph but you should have adequate clinical substantiation to support the claims on the product label, website and other marketing collaterals.  I can connect with you offline if you need more help/guidance. 

Best wishes,

Deshanie Rai, PhD, FACN