New England Journal of Medicine reported an investigation by the Food and Drug Administration (FDA) at Stone Gates Food in Minnesota alleging that a vegan beef protein substitute-Tara flour-was making people sick.
Chief Supply Chain Officer at Stone Gates Food said the U.S. importer of Tara flour claimed the flour was safe and could be classified as GRAS or “generally recognized as safe.” Based on the current rules, once an ingredient is labelled as GRAS by the manufacturer it does not require further testing.
Eating Tara vegan beef unfortunately made more than 400 people seriously sick across 39 states with over 130 people hospitalized. Symptoms of toxic ingestion were stomach pain, nausea, vomiting, fever, weakness and doctors reported liver damage many who needed liver biopsies to find out the cause.
FDA also tested Stone Gates for pesticides, chemicals, bacteria, heavy metals or other toxins, and agreed that it was likely Tara flour that was making people sick.
What is Tara flour?
Tara flour or powder is a newer additive or ingredient to the U.S. market and is popular as a vegan plant-based beef substitute because it is rich in non-animal proteins. It is also used as an alternative to wheat flour, and can be added to shakes, muffins, and cookies to increase the protein content. It is made from the seed of Tara trees found in South America mostly in Peru. It is also an ingredient that has been added to French Lentil and leak crumbles.
FDA says based on the dangerous side effects experienced by people eating Tara flour enriched vegan beef that Tara flour, “no longer meets the GRAS or generally recognized as safe and is an unapproved food additive,” and is now removed from this classification.
Can we trust food labeling?
Food labeling may list ingredient as safe without warnings as it did with vegan beef because the company claimed it was “generally recognized as safe,” without proper tested. This is especially dangerous when adding new ingredients or products to our food.
The FAA or Food Additive Amendment requires that all food additives, like Tara flour, be approved by the FDA before introducing into the food supply. However, the FDA has a loophole that if the additives are called GRAS by the manufacturer, it does not require FDA approval to be labeled as an ingredient. In other words, if the food manufacturer calls an ingredient “GRAS,” they are not obligated to report to the FDA or test the ingredient for safety before releasing it to the public for consumption.
The GRAS exception not only allowed the vegan beef manufacturer in Minnesota to include harmful additives but applies to many substances that enhances flavor, texture, extends shelf life, or used as a replacement for meat, eggs, or nuts.
In fact, manufacturers are using GRAS to bypass FDA testing and safety standards. A good example of this is with an ingredient in green tea called epigallocatechin-3-gallate, that is safe when naturally found in green tea but when used in larger amounts or in pill or capsule form may cause harm including liver damage. In low doses or doses found naturally in green tea, it may reduce inflammation, aid in weight loss, and prevent heart disease.
Does FDA protect us from vegan beef?
The consumer protection agency sued the FDA claiming they are delegating their responsibility in allowing manufacturers to label ingredients as safe without safety testing as they did with vegan beef.
A federal district court based on the current legislation says the FDA is not responsible due to the loophole that if a company calls an ingredient GRAS or “generally recognized as safe,” it does not require FDA approval. The court did agree the FDA should take a more active role in ensuring safety of ingredients in labeling.
In the absence of FDA action to restrict GRAS labeling of ingredients or additives to food, states like California have certain food additives including specific food dyes that are linked to health problems banned, and New York recently proposed similar bans. A bill recently introduced in New York would require manufacturers to publicly post the evidence supporting a GRAS determination before marketing a new ingredient in that state.
Is vegan beef safe?
If Tara flour is added to vegan beef, it is not safe. Currently the FDA is restricting the use of Tara flour being added to vegan beef or other food products manufactured in the U.S. In general, plant-based beef can be a healthy part of a balanced diet and may include proteins from plant foods, often pea, soy, wheat protein and mushrooms. It is important to read labels both for safety of ingredients, and also for sodium and fat content. If you are experiencing side effects, please reach out to seek medical help immediately.
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