i- Today FDA announced the publication of an assessment concluding that tara flour does not meet the criteria for generally recognized as safe (GRAS) status and that its use in food constitutes an unapproved food additive use which renders the food adulterated. The assessment comes almost 2 years after Daily Harvest’s June 2022 recall of a product containing tara flour following serious reports of adverse events, including liver toxicity and hospitalizations.
- Tara flour is derived from the germ of the plant Tara spinosa (aka Caesalpinia spinosa or tara plant) and should not be confused with tara gum, which is derived from the endosperm of the tara plant and which FDA notes has a “well established” safety profile when used as a thickening agent/or stabilizer in food.
- FDA’s assessment concludes that there is little information describing the composition or effects of tara flour and that the few studies that do exist are not sufficient to support a GRAS conclusion based on scientific procedures. Indeed, one study on a non-protein amino acid in tara flour (baikiain) was suggestive of liver toxicity. Furthermore, the Daily Harvest recall, as well as other adverse event reports, are inconsistent with a GRAS conclusion. FDA also found no evidence that tara flour was consumed in food prior to 1958 which is necessary (but not sufficient) for a GRAS conclusion based on common use in food.
- Last September, the Canadian Food Safety Inspection Agency (CFIA) issued a similar notice, advising industry not to use tara flour because it was likely a novel food (i.e., a food without a safe history of use) and CFIA had not conducted a pre-market assessment as required for novel foods.
FDA Concludes that Tara Flour is Not GRAS
Wednesday, May 15, 2024
