Direct-to-consumer food service Daily Harvest, backed by investors like Gwyneth Paltrow and Serena Williams, introduced a frozen vegetable-based meat alternative, French Lentil + Leek Crumbles, in April 2022. However, by June of the same year, the company had to voluntarily recall the product following 470 complaints of gastrointestinal, liver, bile duct, and gallbladder issues. Social media influencers, including Cory Silverstein, who had been sent the product for promotion, reported severe pain and abnormal liver enzyme levels after consumption. Luke Wesley Pearson, another content creator, underwent emergency gallbladder surgery after eating the crumbles twice, and two other consumers also reported gallbladder surgery after consuming the meat substitute. Daily Harvest did not comment on the situation when contacted.

Initially, the US Food and Drug Administration (FDA) suspected manufacturing plant contamination as the cause of the illnesses. However, the plant tested negative for pathogens. Daily Harvest's internal investigation soon focused on a new ingredient used for its high-protein content: tara flour. Tara flour, derived from the seed pods of a Peruvian shrub, is different from tara gum, which has been safely used as a thickening agent in foods. The FDA stated that tara flour had "not been adequately characterized nor previously utilized as a human food ingredient in the United States." Daily Harvest's founder and CEO, Rachel Drori, announced in July 2022 that this was the first and only time tara flour was used, and it was included under the FDA's "generally recognized as safe" (GRAS) designation.

The GRAS designation, established by a 1958 amendment to the 1938 Federal Food, Drug, and Cosmetic Act, was intended for safe, commonly used ingredients like oil, vinegar, and baking soda. However, tara flour was found to be unsafe by the FDA in May 2024, nearly two years after it had caused hundreds of illnesses. During this period, other manufacturers could have used the now "unapproved food additive." Dr. Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance, criticized the food regulatory system, stating, "No one is minding the store." He coauthored a paper on the issue published in The New England Journal of Medicine in September.

The misuse of the GRAS standard and the delay in FDA response have been ongoing for decades, according to critics. Illinois Secretary of State Alexi Giannoulias described GRAS as a loophole for food manufacturers to bypass FDA oversight. Representatives for food and beverage companies, however, argue that the industry adheres to the FDA's rigorous safety system, with GRAS playing a crucial role in innovation while meeting safety standards.

The FDA requires manufacturers to review existing scientific literature or consult unbiased experts to determine if a new ingredient can be designated as GRAS. Such requests for GRAS classification should be filed with the FDA before using any ingredient not in use before 1958. However, the FDA's voluntary guidance does not establish legally enforceable responsibilities, and critics argue that manufacturers can easily bypass this step.

The US Government Accountability Office criticized the FDA's oversight of GRAS substances in a 2010 report, stating that the agency generally does not have information about other GRAS determinations companies have made. A 2014 report by the Natural Resources Defense Council found that 56 companies relied on undisclosed GRAS safety determinations for 275 chemicals. The Environmental Working Group's 2022 analysis revealed that nearly 99% of new chemicals used in food or food packaging since 2000 were approved by the food and chemical industry, not the FDA.

Critics argue that the FDA's lack of action and slow response have left it playing catchup, with states taking more aggressive measures. In October 2023, California banned four substances due to serious health concerns, and additional chemicals are being targeted by legislative bills in 11 states. The FDA's new Human Foods Program, announced in 2023, includes a new method of post-market analysis of chemicals already in food, including those that bypassed the voluntary GRAS requirements. However, critics say this plan does not address the regulatory loophole that allows potentially harmful ingredients to be added to food without first being evaluated for safety.

The debate over the GRAS process and the FDA's role in food safety regulation continues, with calls for a reassessment of the system to protect public health and ensure the safety of the food supply. The FDA's response to these concerns and its actions moving forward will be critical in shaping the future of food safety in the United States.