USA – In a move towards enhancing the regulation of food ingredients, the U.S. Food and Drug Administration (FDA) has revoked the Generally Recognized as Safe (GRAS) status for tara flour.

This decision forms part of the FDA’s broader initiative to more rigorously and transparently assess food ingredients, additives, and chemicals.

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), any ingredient intended for use in food must be authorized by the FDA as a food additive unless qualified experts determine it to be GRAS or meet specific exceptions.

Without this designation, an ingredient is deemed unsafe and any food containing it is considered adulterated.

The reassessment of tara flour was spurred by its association with a foodborne illness outbreak in 2022 linked to a Daily Harvest leek and lentil crumble product.

Over 400 cases of illness were reported. Although Daily Harvest identified tara flour as a potential contributor to the outbreak, the FDA has not confirmed this ingredient as the cause. Nonetheless, the incident prompted a thorough review of its safety.

The FDA’s investigation concluded that there is insufficient data to support the safe use of tara flour in food products.

Moreover, no existing regulation authorizes its use as a food additive. As a result, tara flour no longer holds the GRAS designation, and its use in food products is considered unsafe.

Implications for manufacturers and importers

Manufacturers considering using tara flour are now responsible for ensuring its safety and legality. The FDA encourages these manufacturers to consult with the agency to verify compliance with food safety regulations.

Currently, there is no known domestic production or widespread use of tara flour in food products within the United States.

In addition, the FDA has implemented enhanced screening procedures at ports of entry to prevent the importation of tara flour, either as a bulk ingredient or within food products. So far, no shipments containing tara flour have been detected.

The broader GRAS debate

The revocation of tara flour’s GRAS status highlights ongoing concerns about the FDA’s oversight of food ingredients.

The GRAS system has faced criticism for allowing potentially unsafe additives to enter the food supply without rigorous scrutiny. This perceived regulatory gap has prompted legislative actions at the state level.

In California, the recently passed California Food Safety Act seeks to ban certain potentially toxic additives from foods produced or sold within the state. Assembly member Jesse Gabriel, who sponsored the bill, described it as a measure to address the “concerning lack of federal oversight” and referred to GRAS as a “loophole in federal law.”

Similarly, New York State has introduced Assembly Bill A9295, aiming to curb the industry’s exploitation of the GRAS determination process. This bill would require businesses to notify the state when they deem a substance GRAS and plan to market it within New York.

As the FDA continues to refine its regulatory framework and address gaps in food safety oversight, the revocation of GRAS status for ingredients like tara flour marks a critical step.

The FDA’s actions underscore the need for robust data and transparent evaluation to ensure the safety of food ingredients. Meanwhile, state legislatures remain active in pushing for stricter regulations to protect public health.

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