Food safety and your health- the FDA is on notice

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DoctorH
M.D.

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Health and Human Services (HHS) issued a warning that food manufactures must report health safety information on new ingredients added to our food and the Food and Drug Administration (FDA) must get rid of legal “loopholes,” and step it up.

How can food additives be unsafe?

It is not unusual for food companies to add new additives without necessarily testing for safety. Based on the Food Additives Amendment (FAA), it requires all food additives to be vetted and reported to the FDA before entering the food supply however since 1997, reporting is “voluntary,” meaning if the company feels the ingredient or chemical is safe or “generally regarded as safe,” called GRAS then could choose not to report.

GRAS classification was intended for ingredients that are common and regarded truly as safe, like salt, baking powder, or baking soda not new additives or chemicals.

In fact, 99 % of all food chemicals introduced since 2000 were greenlighted without FDA approval, the agency responsible for ensuring food safety. And, even if reported to the FDA, the food company could withdraw the report and use in food without safety testing if they felt generally regarded as safe or GRAS.

The practice of not properly vetting new food additives made people sick as seen with Tara flour, food dyes, brominated vegetables oils or bromine used in citrus and sports drinks, certain green tea extracts, and the list goes on.

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 doesn’t 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.

What’s happening to make food safer?

March 10, 2025, U.S. Department of Health and Human Services (HHS), and FDA are now on notice to promote “radical,” transparency to make sure all Americans know what’s in their food. They are drilling down on the rules around GRAS or additives that are ‘generally accepted as safe,” to be closely vetted and to eliminate the food companies’ ability to approve new additives without careful FDA scrutiny including submitting safety studies before allowing a new ingredient to be released into our food supply.

In the absence of FDA action to restrict GRAS labeling of ingredients or additives to food, states like California have 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 evidence supporting a GRAS determination before marketing a new ingredient in that state.

“Too far too long, manufacturers have exploited a loophole.” It’s time to eliminate their self-affirming process. Health and Human services (HHS) are committed to exploring ways with Congress to close the GRAS loophole. It is time to make food safe again and step it up.

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