Over seven years ago, as a student at Northeastern University, I sat in Dr. Darin Detwiler’s lectures in the regulatory affairs program learning about the U.S. patchwork regulatory system. However, I never fully understood the detrimental repercussions of our fragmented systems governing food safety and oversight until I fell victim to the dangerous gaps in U.S. food regulations. The brunt of toxic food poisoning left me feeling helpless, as I thought I was dying from a mysterious illness.
MY WORST NIGHTMARE. I started ordering vegan and gluten-free meals from Daily Harvest because I was looking for a way to eat clean and healthy while working long hours as director of education for a dietary supplement company. I loved the meals! They gave me an assortment of smoothies, flatbreads and harvest bowls. Then, they launched innovative new products called crumbles. They reminded me of an alternative sausage product, and I thought they were a perfect companion to scrambled eggs. I bought both options, but the French lentils and leeks crumbles soon became my worst nightmare.
I visited the emergency room but didn’t learn what made me sick until I received an email from Daily Harvest two weeks after I first became ill telling me to dispose of the French lentils and leeks. They said they would give me a $10 credit for each bag I had purchased.
DELICIOUS BUT POISONOUS. They were delicious but poisonous. I suffered digestive symptoms lasting for days, horrible heartburn, abdominal pain, extreme fatigue, weakness, muscle and body aches, fever, dark urine and intense itching. I was so sick that I lost 10 pounds in a week. It has taken me months to recover from this ordeal, and still, I occasionally have abdominal pain/spasms in my liver region that make me concerned about long-lasting damage.
I messaged Daily Harvest through their app to let them know that I got sick. It turns out that I wasn’t the only one. As of June 2022, Daily Harvest had received 470 complaints related to the poisoning. In reading the news, I learned there were other victims experiencing similar abdominal pain and gastrointestinal symptoms. At least 25 people had their gallbladders removed, and some had to have liver biopsies. Daily Harvest is now facing legal action after so many of their customers became severely ill.
THE CULPRIT: TARA FLOUR. The culprit was a new ingredient called tara flour. The working theory is that tara flour, made from the seeds of a tree native to Peru, contains high amounts of a nonprotein amino acid called baikiain that some individuals’ bodies cannot process.
Shouldn’t this have been understood before this ingredient went to market? Before eating a new ingredient, the consumer believes that food companies know that the products they are making are safe for them to consume.
FRUSTRATIONS AS AN INDUSTRY INSIDER. I read food labels, so how could I become a victim? Because I had never heard of tara, I assumed it was taro. Maybe it was a misprint. It happens. In my line of work, I catch plenty of misprints before they go to market. (Even Microsoft keeps trying to correct the spelling of the word as I type this article.)
But this was tara, not taro. Taro is the root vegetable used as flour and made into chips that have a sweet taste similar to sweet potatoes. Those I’ve eaten before. So, I thought I would give these new crumbles a try. Another hard lesson: Never make assumptions in the food industry. An assumed typo could be a new ingredient.
I fully understand food companies are trying to compete in innovation when the public is demanding plant-based protein. It’s a race to bring the next big thing to market. But at what cost? Our Generally Recognized as Safe (GRAS) process demonstrates a weak link in food regulation, essentially a ticking bomb that blasted over 400 Daily Harvest customers.
GRAS substances are exempt from food additive requirements. Basically, this exemption allows foods that are common substances known to be safe, such as salt and sugar, to be used in foods without being subject to testing and government review.
According to the Food, Drug, and Cosmetic Act section 201(s), the general recognition of safety for a food substance must be established either by scientific procedures or experience based on common use in food before Jan. 1, 1958. If not in common use prior to 1958, then GRAS is based on scientific procedures and can be self-affirmed, which means a company is permitted to make self-determination that the substance or ingredient they intend to use is safe.
As far as I can see, tara flour has not been used in the food industry. Tara gum, which is a different ingredient from the same plant, has been used in small amounts as a thickening agent. The use of the food additive tara gum does not give companies the right to use tara flour in their recipes. The issue with GRAS is that although the FDA will review GRAS submissions when submitted, it is not required, and most companies will opt for what is called self-affirmed GRAS. This gives companies permission to market a food additive immediately — unless it is a new food additive, and then it must obtain premarket approval. Where is the tara flour premarket approval?
There isn’t a clear path of regulation for either meal-kit or fresh-frozen meal delivery businesses. Do they fall under regulations for restaurants, local health departments or all states that they ship to? My understanding is that currently, these types of meal delivery businesses are regulated under retail food establishments, which means they are not registered with the FDA.
The Daily Harvest fiasco of an unrecognized food additive making people sick across the country has brought this gaping hole to the attention of food safety organizations. Ready-made food and meal-kit delivery businesses grew at an unprecedented rate during the pandemic and will continue to be a service that grows out of convenience. Can we establish a regulatory plan to protect the consumer as companies innovate with ingredients and services being delivered nationally?
GROWING PAINS. As careful as I’m becoming in monitoring my personal diet, we can’t expect that from the public. They depend on the companies they buy from. I hear people say all the time, “It wouldn’t be sold if it wasn’t safe.” And it’s supposed to be.
I’m hoping the unfortunate events of the Daily Harvest poisoning will provide a lesson of caution to the many food companies that are trying to keep up with consumer diet trends. As an industry insider, I understand their quest to do so.
The current call to action is for both food companies and regulatory bodies. It’s time to review and plan for the future as companies experiment in an attempt to make products that delight an ever-changing customer desire. I ask that the risk be considered before rushing to market with new ingredients. It’s not worth it to consumer safety or your bottom line.
Jen Bickerton, DC, MS, founder of The Vitamin Advisor, with 25 years of experience in healthcare and a Master of Science in Regulatory Affairs for the Food Industry, is pro-industry with a consumer safety-first approach. She offers dietary supplement strategy sessions, structure-function claim support and consumer product education design for entrepreneurs, dietary supplement companies and start-up brands.
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