Daily Harvest, a direct-to-consumer food service with investors such as Gwyneth Paltrow and Serena Williams, began selling frozen vegetable-based meat substitute French Lentil + Leek Crumbles in April 2022.
By that June, Daily Harvest had voluntarily recalled the crumbles after receiving 470 complaints of gastrointestinal, liver, bile duct and gallbladder illness.
“I’ve never experienced pain like that,” Cory Silverstein told CNN Business at the time. He and his wife were among several social media influencers who were sent the product to promote. After eating the crumbles, Silverstein said, he had to go to an urgent care center, where his liver enzymes tested at levels 12 times above normal.
Another content creator who received a promotional package, Luke Wesley Pearson, posted that he underwent emergency gallbladder surgery after eating the crumbles twice. Two other consumers told CNN they also had gallbladder surgery after consuming the meat substitute.
CNN reached out to Daily Harvest, and the company declined to comment for this report.
Investigation rules out contaminants
At first, US Food and Drug Administration officials investigating the outbreak thought the illnesses could be due to contamination at the manufacturing plant. But the factory tested negative for pathogens. Soon, Daily Harvest had narrowed its internal investigation to a new ingredient used for its high-protein content: tara flour.
Tara flour is one of two products made from the seed pods of a thorny shrub native to Peru. One of those, tara gum, has been used safely for years as a thickening agent or stabilizer in human foods. However, tara flour is made differently than tara gum, and the flour has “not been adequately characterized nor previously utilized as a human food ingredient in the United States,” according to the FDA.
“This was the first and only time we’ve used tara flour, which has been available and used in the North American market as a plant-based source of protein prior to our use,” Daily Harvest founder and CEO Rachel Drori announced in July 2022.
Daily Harvest had included the ingredient in the crumbles under the FDA’s “generally recognized as safe” or GRAS designation. Created by a 1958 amendment to the 1938 Federal Food, Drug and Cosmetic Act, GRAS was intended to be narrowly applied to safe, commonly used ingredients in the nation’s food supply, such as oil, vinegar and baking soda.
As some consumers had discovered, tara flour was not safe, the FDA decreed in May 2024 — nearly two years after the ingredient sickened hundreds. During that time, however, other manufacturers could have used the now-“unapproved food additive.”
“This incident shows how broken our food regulatory system is. It’s completely backwards,” said Dr. Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts.
Cohen coauthored a paper on the situation published in September in The New England Journal of Medicine.
“No one is minding the store. Tara flour is introduced into the food supply, and only because there’s an outbreak of liver injury does the FDA even look at whether or not it’s safe,” he said. “Even worse, it takes two years for the FDA to come to that conclusion, all the while leaving consumers at risk.”
A pattern of inaction
Tara flour is a recent example, but the misuse of the GRAS standard — and the delay in FDA response — has been occurring for decades, critics say.
“Tragically for our nation’s public health, GRAS is merely a loophole to enable food manufacturers to bypass FDA oversight and get products more quickly on store shelves,” Illinois Secretary of State Alexi Giannoulias said at a September news briefing.
Representatives for food and beverage companies disagree. Sarah Gallo, senior vice president of product policy and federal affairs for the Consumer Brands Association, told CNN via email that the industry closely adheres to the “rigorous science and evidence-based pre- and post-market safety system established by the FDA that stringently protects America’s food supply.”
“GRAS plays an important role in this proven system, enabling the industry to innovate to meet consumer demand while also meeting FDA’s regulations and safety standards,” Gallo said.
How is GRAS supposed to work?
The FDA states that manufacturers need to do a thorough review of existing scientific literature — or convene a panel of unbiased experts — to determine whether a new ingredient can be designated as GRAS and used in any food sold in the United States.
Such requests for GRAS classification are supposed to be filed with the FDA to get its blessing in advance of incorporating any ingredient not in use before 1958 into a new product.
The FDA set up the current system in the late 1990s when the agency found that it couldn’t keep up with the flood of requests to approve new food additives.
“By 1997 FDA had tentatively concluded that it could no longer devote substantial resources to the GRAS affirmation petition process,” the FDA states on its website. Instead, the agency “established a voluntary GRAS notification program to help ensure that these ingredients are safe under their intended use.”
But as the FDA itself noted, this voluntary guidance does “not establish legally enforceable responsibilities,” and critics say it’s easy for manufacturers to skip this step, adding new ingredients to products without any heads-up to regulators at all.
The US Government Accountability Office, which Congress tasks with evaluating government performance, criticized the FDA’s oversight of GRAS substances in a 2010 report.
“The agency generally does not have information about other GRAS determinations companies have made because companies are not required to inform FDA of them,” the report said.
A 2014 report by the Natural Resources Defense Council, an environmental advocacy group, used federal Freedom of Information Act requests to review how companies communicate with the FDA on new food additives.
The investigation found that 56 companies appeared to rely on undisclosed GRAS safety determinations for 275 chemicals. When the FDA was provided a GRAS request by a manufacturer, however, the report said, the agency was thorough, rejecting or triggering the withdrawal of 1 in 5 requests.
A more recent 2022 analysis conducted by the Environmental Working Group found that nearly 99% of new chemicals used in food or food packaging since 2000 were green-lit for use not by the FDA but by the food and chemical industry.
During that period, food manufacturers asked the FDA’s permission to introduce a new substance only 10 times, according to the analysis.
“Industry has gotten a free pass for decades when it comes to food chemical safety,” said Melanie Benesh, vice president of government affairs for the Environmental Working Group. “By exploiting this loophole, industry has been able to depend entirely on their own science to determine whether or not an ingredient is safe. And they have been able to downplay some of the increased disease burden that may come with some of the products they make.”
When CNN asked the FDA whether it would be reassessing the GRAS premarket process, the agency pointed to the need for Congress to address the issue.
“Congress writes and enacts laws; it is the FDA’s role to implement laws as written,” an FDA official said in an email.
“Food manufacturers are responsible for marketing safe foods, including ensuring the safety and regulatory status of the ingredients they use in foods before they are available to consumers.”
US states and European Union take the lead
Critics say the lack of action and slow response by the FDA has left the agency playing catchup, tagging along behind more aggressive measures proposed by states.
In October 2023, California banned four substances — brominated vegetable oil or BVO, potassium bromate, propylparaben and red dye No. 3 — due to such serious health concerns as cancer, endocrine and reproductive issues, and heart and liver problems.
Additional chemicals being targeted by legislative bills in 11 states include red dye No. 40; blue dye No. 1 and No. 2; green dye No. 3; yellow dye No. 5 and No. 6; titanium dioxide; and azodicarbonamide, a dough conditioner that is also used in yoga mats, according to the Environmental Working Group.
The FDA had declared BVO — a vegetable oil used in citrus sodas and sports drinks — no longer GRAS in 1970, but the agency did not officially ban the additive from use in the US food supply until July 2024.
“The FDA knew for decades that brominated vegetable oil or BVO would be harmful, but it was allowed to remain in use at the request of food manufacturers,” said Giannoulias, a coauthor of the Illinois Food Safety Act, which was passed by the Illinois Senate in April 2024.
The FDA banned red dye No. 3 from use in cosmetics and externally applied drugs due to a link to thyroid cancer in animals in 1990, but despite petitions from advocacy groups, the agency continues to allow the dye to be used in thousands of foods, dietary supplements and ingested drugs.
“BHA (butylated hydroxyanisole) is another food chemical linked to cancer, used in thousands of foods ranging from cured meats to kids’ cereals,” the Environmental Working Group’s Benesh said. “A doctor petitioned the FDA to ban it in 1990, but 34 years later, the petition is still pending, and the FDA has yet to respond.”
The European Union decided that bisphenol A, commonly known as BPA, “was harmful at hundreds of times lower levels than what was previously considered safe,” Benesh said. However, a petition for action filed with the FDA in 2022 is still waiting the agency’s response, she added.
The Consumer Brands Association pointed to recent GRAS actions by the FDA, including an updated 2024 list of chemicals the agency plans to review.
According to critics, however, the list contains chemicals already targeted by states, chemicals not directly added to food or packaging, and chemicals that have been under FDA review for years without action. Even today, critics say, the FDA lags behind modern science.
FDA sets a new course
Facing years of criticism, the FDA announced a new Human Foods Program in 2023, which includes a new method of post-market analysis of chemicals that already exist in food — including those that bypassed the voluntary GRAS requirements.
“There is no statutory requirement for FDA-initiated post-market review or for the industry to conduct safety testing and to share that data with FDA after a chemical is introduced into the market,” Jim Jones, the FDA’s deputy commissioner for human foods, told more than 300 attendees last month at the first public hearing on post-market review.
“As such, given our limited resources, the agency has not established a systematic process to ensure that our original determinations of safety held up over time,” Jones said.
The FDA action comes after a more recent GAO analysis that found that the agency did not track information in a manner that would allow it to quickly identify substances that needed to be examined “because new safety information may have emerged.”
The FDA’s proposed approach is broad, addressing food and color additives, food contact substances, potential contaminants and pesticides, and ingredients already considered GRAS.
Although this new plan may boost oversight of chemicals already on the market, critics say it does nothing to address the regulatory loophole that still allows potentially harmful ingredients to be added to food without first being evaluated for safety.
“FDA should take a new look at the entire GRAS process and make changes to protect public health and take the burden off of the post-market review process,” said Thomas Galligan, principal scientist for food additives and supplements with the Center for Science in the Public Interest, a consumer advocacy organization, at the recent FDA hearing.
“Companies are making decisions about the safety of the chemicals in our food in secret, and FDA cannot ensure the safety of our food supply.”
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