Last week, the legality of the self-affirmed GRAS (Generally Recognized As Safe) framework – known popularly as “self-GRAS” -- was confirmed by a federal court. Self-GRAS allows companies that have self-determined the safety of their food ingredients to be exempt from pre-market review by FDA, based on reviews by independent, qualified expert panels. When used in the food supply, these ingredients also qualify for exemption from the New Dietary Ingredient notification (“NDIN”) requirements for dietary supplements. Problems with a mandatory NDIN-only approach were brought to light recently when two comprehensive and science-driven NDINs for hemp extract ingredients were rejected by the FDA.
This court decision is great news for CBD companies that have already invested substantial resources to establish the safety of their products through self-GRAS. More importantly, it reinforces the importance of congressional efforts – through HR 841 and S 1698 -- to allow CBD companies to have access to all of the same safety pathways provided to other dietary supplements and food and beverage ingredients.
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