In the spring, folks who ordered from a company that sells pre-assembled smoothies and other frozen foods for home delivery, started getting sick—really sick—after consuming an item called “French Lentil and Leek Crumbles” (Crumbles). Daily Harvest, the manufacturer, recalled the product on June 17. A month later, Daily Harvest said it had ruled out various food-borne pathogens, mycotoxins, heavy metals, and major allergens and had “identified tara flour as the cause of the issue.”
By the end of July, FDA reported the product had been linked to 329 illnesses and 113 hospitalizations in 36 states—a surprising number for a product that sold only 28,000 items. Consumer Reports described the health effects as fever, fatigue, vomiting, diarrhea, and liver problems. At least 25 people who consumed the Crumbles required surgery to remove their gallbladders.
Tara flour is made from the seeds or pods of the tara tree (Caesalpinia spinsoa), which grows in the Andes. Tara flour is relatively unknown in the U.S. and was an ingredient—a source of protein—in the Crumbles. A second product from the tree is tara gum, a starch ingredient listed in more than 500 products according to the EWG Food Scores, but made from another portion of the seed or pod. The tara gum was apparently not an ingredient in Crumbles.
Both tara flour and tara gum have never been reviewed by FDA for safety.
We find no evidence that FDA reviewed tara flour or tara gum for safety (although the recall has likely prompted an investigation). Therefore, it is fair to assume that the food manufacturer must have determined that the substances are GRAS before using them in food. The GRAS designation means that using a substance is not only safe but that the broader scientific community recognizes it as safe. For an in-depth look at the GRAS process and designation in the context of tara flour, see Neal Fortin’s article in Food Safety News.
Congress intended for companies to secure FDA’s approval of novel ingredients as food additives through a petition process before companies could use them. In the 1990s, companies began to bypass the process in earnest, by self-certifying even novel substances as GRAS. FDA explicitly allowed the practice in 1997, when it established a voluntary GRAS notification process. The agency encouraged companies to participate by promising an opinion in 6 months, avoiding public comments, and undermining the ability of the public to challenge the actions.
Over the last 20 years, less than 1% of the new substances added to our food have been approved through the more rigorous food-additive petition process established by Congress.
Making the industry-friendly GRAS process even worse for consumers, FDA lacks any systematic means to investigate whether companies are complying with GRAS requirements—especially when there is no notice to alert them to a company’s GRAS determination. As a result, we usually wait until the harm reaches the news, as with tara flour recently and caffeinated alcoholic beverages a decade ago.
Tara flour is yet another example of how FDA’s GRAS program is broken—putting the health of Americans at unnecessary risk. FDA should use its big food reboot to fix the program so that we can have confidence in the safety of our food. The agency should also work with members of Congress who have introduced bills intended to fix GRAS and to have FDA reevaluate old food safety decisions in light of new science.