‘I’ve never felt pain like this’: Consumers bear the consequences of untested food ingredients

In April 2022, Daily Harvest, a direct-to-consumer food brand backed by investors like Gwyneth Paltrow and Serena Williams, launched its frozen vegetable-based meat substitute, French Lentil + Leek Crumbles.

By June, Daily Harvest had voluntarily recalled the product after receiving 470 reports of gastrointestinal issues, liver damage, and bile duct or gallbladder problems.

‘I’ve never felt pain like this,’ Cory Silverstein told Dinogo Business. He and his wife, both influencers, were sent the crumbles to promote. After consuming them, Silverstein’s liver enzymes were found to be 12 times higher than normal, forcing him to visit an urgent care center.

Luke Wesley Pearson, another influencer who received the product, shared that he required emergency gallbladder surgery after consuming the crumbles twice. Two other consumers also reported having gallbladder surgery following their consumption of the meat substitute.

Dinogo contacted Daily Harvest for a statement, but the company chose not to comment on this report.

Investigation Rules Out Contamination

Initially, officials from the US Food and Drug Administration (FDA) suspected that the illnesses might have been caused by contamination at the manufacturing facility. However, after testing, the factory was found to be free of pathogens. Daily Harvest soon focused its internal probe on a new ingredient used for its high-protein content: tara flour.

Tara flour comes from the seed pods of a spiny shrub native to Peru. While tara gum, another product derived from the same plant, has been safely used for years as a thickener or stabilizer in food, tara flour is processed differently. The FDA notes that tara flour has 'not been adequately characterized nor previously used as a food ingredient in the United States.'

Rachel Drori, founder and CEO of Daily Harvest, stated in July 2022, 'This was the first and only time we’ve used tara flour, which had been available in North America as a plant-based protein source before our usage.'

Daily Harvest had classified tara flour under the FDA’s 'generally recognized as safe' (GRAS) designation. Introduced by an amendment to the 1938 Federal Food, Drug, and Cosmetic Act, GRAS was originally designed to apply to safe, widely used ingredients in the food supply, such as oil, vinegar, and baking soda.

In May 2024, the FDA declared tara flour unsafe — nearly two years after the ingredient had caused illness in hundreds of consumers. However, other manufacturers may have used the now-labeled 'unapproved food additive' during that time.

Dr. Pieter Cohen, an associate professor of medicine at Cambridge Health Alliance in Somerville, Massachusetts, commented, 'This incident highlights the flaws in our food regulatory system. It’s completely backward.'

Cohen coauthored a paper on the issue, which was published in September in The New England Journal of Medicine.

'No one is overseeing this process. Tara flour is added to the food supply, and only after an outbreak of liver damage does the FDA investigate its safety,' Cohen said. 'Even more troubling, it took the FDA two years to reach this conclusion, all the while leaving consumers vulnerable.'

A History of Inaction

Tara flour may be a recent case, but critics argue that the abuse of the GRAS standard and the FDA's slow response have been ongoing issues for decades.

'Unfortunately, the GRAS system has become a loophole, allowing food manufacturers to sidestep FDA oversight and get products to market more quickly, with consequences for public health,' said Illinois Secretary of State Alexi Giannoulias during a September press conference.

Food and beverage industry representatives have a different view. Sarah Gallo, senior vice president of product policy and federal affairs for the Consumer Brands Association, told Dinogo in an email that the industry strictly follows the 'rigorous science and evidence-based pre- and post-market safety system established by the FDA to safeguard America’s food supply.'

'GRAS plays a crucial role in this proven system, allowing the industry to innovate and meet consumer demand while complying with the FDA’s regulations and safety standards,' Gallo explained.

How Does GRAS Work?

According to the FDA, manufacturers must thoroughly review existing scientific research or consult an unbiased panel of experts to assess whether a new ingredient can be classified as GRAS and allowed for use in food sold in the United States.

Requests for GRAS classification should be submitted to the FDA for approval before using any ingredient not in the food supply before 1958 in a new product.

In the late 1990s, the FDA established the current system after it became clear the agency couldn't keep up with the growing volume of requests to approve new food additives.

'By 1997, the FDA had tentatively concluded that it could no longer allocate substantial resources to the GRAS affirmation petition process,' the agency explains on its website. Instead, it introduced a 'voluntary GRAS notification program' to help ensure that ingredients are safe for their intended use.

However, as the FDA itself acknowledges, this voluntary program 'does not create legally enforceable obligations,' and critics argue that it allows manufacturers to bypass the process entirely, adding new ingredients without notifying regulators.

In a 2010 report, the US Government Accountability Office, which is tasked by Congress with assessing government performance, criticized the FDA’s oversight of GRAS substances.

'The agency generally lacks information about other GRAS decisions made by companies because they are not required to notify the FDA,' the report stated.

A 2014 report by the Natural Resources Defense Council, an environmental advocacy organization, utilized federal Freedom of Information Act requests to examine how companies communicate with the FDA regarding new food additives.

The investigation revealed that 56 companies appeared to rely on undisclosed GRAS safety determinations for 275 chemicals. However, when the FDA did receive a GRAS request from a manufacturer, the agency was diligent, rejecting or prompting the withdrawal of one in five requests, the report noted.

A more recent 2022 analysis by the Environmental Working Group found that nearly 99% of new chemicals used in food or food packaging since 2000 were approved for use not by the FDA, but by the food and chemical industries themselves.

Over that period, food manufacturers sought the FDA's approval to introduce a new substance only 10 times, according to the analysis.

'For decades, the food industry has enjoyed a free pass when it comes to the safety of food chemicals,' said Melanie Benesh, vice president of government affairs at the Environmental Working Group. 'By exploiting this loophole, the industry has relied solely on its own science to determine ingredient safety, often downplaying the potential increase in disease burden linked to some of their products.'

When Dinogo inquired whether the FDA would reconsider the GRAS premarket process, the agency pointed to Congress as the entity that needs to address the matter.

'Congress writes and passes laws; the FDA's role is to implement them as written,' an FDA official stated in an email.

'Food manufacturers are accountable for marketing safe products, including ensuring the safety and regulatory status of the ingredients they use before making them available to consumers,' the official added.

US states and the European Union take the lead

Critics argue that the FDA's delayed response has left it playing catch-up, trailing behind more proactive measures put forward by individual states.

In October 2023, California enacted a ban on four substances — brominated vegetable oil (BVO), potassium bromate, propylparaben, and red dye No. 3 — due to significant health risks, including cancer, reproductive issues, endocrine disruption, and liver and heart problems.

Legislation in 11 states is targeting additional chemicals, such as red dye No. 40, blue dyes No. 1 and 2, green dye No. 3, yellow dyes No. 5 and 6, titanium dioxide, and azodicarbonamide — a dough conditioner also found in yoga mats, according to the Environmental Working Group.

The FDA had already revoked BVO’s GRAS status in 1970, but it wasn't until July 2024 that the agency officially banned the additive from the US food supply.

“The FDA was aware for decades that brominated vegetable oil (BVO) posed risks, yet it remained approved for use due to lobbying from food manufacturers,” said Giannoulias, co-author of the Illinois Food Safety Act, which was passed by the Illinois Senate in April 2024.

The FDA prohibited the use of red dye No. 3 in cosmetics and external medications in 1990 after animal studies linked it to thyroid cancer, but despite petitions from advocacy groups, the dye continues to be used in thousands of foods, dietary supplements, and oral medications.

“BHA (butylated hydroxyanisole) is another food additive linked to cancer, found in a wide range of foods from cured meats to children's cereals,” said Benesh from the Environmental Working Group. “A doctor petitioned the FDA for its ban in 1990, but after 34 years, the petition remains unresolved, with no action taken by the FDA.”

The European Union concluded that bisphenol A (BPA) is harmful at levels much lower than previously thought to be safe, according to Benesh. Meanwhile, a petition filed with the FDA in 2022 remains unanswered, she noted.

The Consumer Brands Association highlighted recent actions taken by the FDA regarding GRAS, including a revised 2024 list of chemicals the agency plans to assess.

Critics, however, argue that the list includes chemicals already being addressed by states, substances not directly added to food or packaging, and those that have been under FDA review for years with no resolution. They also point out that the FDA is still behind the latest scientific developments.

The FDA responds to years of critique with the introduction of a new Human Foods Program in 2023, which incorporates a new approach to post-market analysis for chemicals already present in food, including those that bypassed the voluntary GRAS process.

In response to mounting criticism, the FDA unveiled a new Human Foods Program in 2023, introducing a method for analyzing chemicals already in the food supply, including those that sidestepped the voluntary GRAS system.

Jim Jones, the FDA’s deputy commissioner for human foods, explained to over 300 attendees at the first public hearing on post-market review that there is no legal obligation for the FDA to conduct post-market reviews or require the industry to share safety testing data after a chemical enters the market.

Jones added that, due to limited resources, the agency has not put in place a systematic process to verify if the safety assessments made at the time of approval remain valid over time.

The FDA’s action follows a recent Government Accountability Office (GAO) report, which revealed that the agency lacked the necessary tracking mechanisms to quickly identify substances that may require re-evaluation due to emerging safety concerns.

The FDA’s proposed plan covers a wide range of substances, including food and color additives, food contact materials, potential contaminants, pesticides, and ingredients previously deemed GRAS.

While this new plan may improve oversight of existing chemicals, critics argue that it fails to address the regulatory gap that still permits potentially hazardous ingredients to be added to food without undergoing safety assessments first.

Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest, urged the FDA to reassess the entire GRAS process to better protect public health and reduce the burden on post-market reviews during a recent hearing.

He also criticized the lack of transparency, stating, 'Companies are determining the safety of food chemicals behind closed doors, and the FDA is unable to guarantee the safety of our food supply.'