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FDA Rejects Two NDI Filings on Hemp Extracts

The US FDA rejected two New Dietary Ingredient notifications for CBD ingredients. Industry stakeholders have commented that the rejection underscores that there will be no immediate pathway forward full spectrum CBD in supplements. Federal law requires that New Dietary Ingredients that were not on the market prior to October 15, 1994 must file a notification with FDA demonstrating that the ingredient is reasonably expected to be safe. This was meant to be a lesser standard of proof than what is required for food additives based on the idea that supplements are consumed in lesser quantities. The FDA gave prior use as a drug and insufficient safety information as two reasons for rejection of the CBD ingredients. It may be that a legal pathway for CBD is determined by Congress.

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Posted on 22 September 2021