In May 2024, the FDA announced that it would ban the unapproved food additive tara flour. The ingredient was used in some food products as a protein source until it was identified as an ingredient of interest in an outbreak associated with Daily Harvest plant-based crumbles. Mandatory premarket review of food chemicals could help prevent future outbreaks.
Tara flour associated with an outbreak from Daily Harvest plant-based Crumbles
Tara flour comes from the seeds of a type of South American tree called the tara tree. Tara flour is not a common food additive in the US but has been used by some manufacturers as a plant-derived protein source. The meal delivery service Daily Harvest began using tara flour as an ingredient in its lentil and leek plant-based Crumbles. In June 2022, 393 people were sickened and 133 were hospitalized, some with permanent organ damage, after eating the Daily Harvest product. Daily Harvest voluntarily recalled the Crumbles.
In May 2023, the company stated that a chemical in tara “appears to be the cause of the [reported] issues.” In May 2024, the FDA finally completed its own safety review and determined that tara flour is an unsafe food additive. The agency stated that “[t]he serious adverse events and liver injury with food products containing tara flour raise serious safety questions.”
The FDA lacked sufficient evidence to consider tara flour to be generally recognized as safe, meaning that manufacturers can no longer use the chemical without first consulting with the agency.
FDA regulation of new food ingredients needs reform
While declaring tara flour to be unsafe was certainly the right call, the FDA’s evaluation of tara flour’s safety should have occurred before the chemical was actively used on the market. Currently, manufacturers have the ability to introduce chemicals and ingredients into our food supply without FDA oversight, and when those ingredients are unsafe, the FDA is forced to play catch-up and react to harm after it occurs. This is simply unacceptable.
If official premarket approval had been required before new food chemicals and ingredients could be used, tara flour would not have been approved, and consumers would have been protected.
How food companies sneak new ingredients past the FDA
The 1958 Food Additive Amendment to the Federal Food, Drug, and Cosmetic Act created a loophole for food ingredients “generally recognized as safe,” or GRAS, exempting them from the FDA’s approval requirements. This exemption was intended to allow common food ingredients—like vinegar, flour, and baking soda—to bypass safety reviews and become available to all food manufacturers. The FDA created a voluntary notification system that allows food companies to self-determine that a new chemical is GRAS and add it to foods without notifying the FDA.
Legally, companies are still required to make a full safety assessment based on publicly available data before they can start using new food chemicals. However, because they are not required to provide the FDA with that assessment, some companies simply start using the chemicals in food without sufficiently assessing the risks or publishing their safety data.
While it is illegal for companies to use food ingredients in new ways without conducting a safety review, the FDA’s weak regulations cannot compel companies to demonstrate that they conducted an adequate safety review before using the chemical.
How you can help reform food laws
Industry should not be allowed to decide in secret what is safe for us to eat. That’s why CSPI is working to reform federal laws and regulations to ensure consumers are protected from unsafe food chemicals. To get involved, you can sign CSPI’s petition calling for the FDA to update food additive regulations so that the FDA decides which chemicals are safe for our foods.
