15 Food Additives That Have Lost GRAS Status Amid Safety Concerns

15 Food Additives That Have Lost GRAS Status Amid Safety Concerns

What Was Once “Safe” May Not Be Anymore

For decades, the Generally Recognized as Safe (GRAS) designation allowed food additives to be used without strict pre-market approval. However, recent scientific findings have forced the U.S. Food and Drug Administration (FDA) to rethink that stance. Over the years, at least 15 substances once considered GRAS have been removed due to emerging health risks, including cancer links, organ toxicity, and metabolic disturbances.

The GRAS loophole, which allows manufacturers to self-certify ingredients without direct FDA review, has been widely criticized. Consumer advocates argue that many unsafe substances may still be lurking in processed foods, waiting for stronger regulation.

Here’s a closer look at 15 food additives that lost their GRAS status and why.

1. Brominated Vegetable Oil (BVO) – 2024 Ban

  • Used In: Citrus-flavored sodas
  • Health Concerns: Neurological damage, hormone disruption
  • FDA Verdict: GRAS revoked in 1970; fully banned in 2024

BVO was first removed from the GRAS list in 1970 after concerns over bromine accumulation in the body. However, it lingered in certain beverages until a 2024 ban officially outlawed it.

2-8. Seven Synthetic Flavoring Substances – Banned in 2018

  • Used In: Candy, baked goods, soft drinks
  • Health Concerns: Carcinogenicity (cancer risk)
  • FDA Verdict: Removed to comply with the Delaney Clause, which bans known carcinogens

These seven artificial flavors were widely used to enhance sweetness, spiciness, and minty profiles in processed foods:

Benzophenone – Floral or sweet flavoring
Ethyl Acrylate – Fruity notes
Eugenyl Methyl Ether (Methyl Eugenol) – Clove-like flavor
Myrcene – Earthy or spicy notes
Pulegone – Minty flavoring
Pyridine – Roasted or nutty tones
Styrene – Sweet or balsamic notes

Though the FDA stated that these substances posed minimal risk at normal exposure levels, their removal was a precautionary measure to align with cancer research findings.

9. Partially Hydrogenated Oils (PHOs) – 2015 Ban

  • Used In: Margarine, pastries, fried foods
  • Health Concerns: Heart disease, trans fat risks
  • FDA Verdict: Declared not safe in 2015; full phase-out by 2018

PHOs were the largest source of artificial trans fats in the American diet. Decades of studies linked them to coronary heart disease, prompting their ban.

10. Triclosan and Triclocarban – 2016 Ban

  • Used In: Antibacterial soaps and food packaging
  • Health Concerns: Hormone disruption, bacterial resistance
  • FDA Verdict: No longer GRAS in consumer antiseptic products

Though often associated with hand soaps, Triclosan and Triclocarban were also used in food packaging and processing before their removal.

11. Caffeinated Alcoholic Beverages – 2010 Ban

  • Used In: Energy-alcohol drinks (e.g., Four Loko)
  • Health Concerns: Severe intoxication, heart risks
  • FDA Verdict: Deemed unsafe and misleading

The combination of caffeine and alcohol was found to mask intoxication, leading to higher rates of alcohol poisoning and accidents.

12. Ginkgo Biloba – FDA Rejection

  • Used In: Energy drinks, snacks, herbal teas
  • Health Concerns: Carcinogenicity, bleeding risks, liver damage
  • FDA Verdict: Not GRAS-approved for food use

Despite being a common dietary supplement, Ginkgo biloba was never fully approved as a food ingredient due to concerns over liver toxicity and cancer risks in animal studies. While still available in supplement form, the FDA warns against its indiscriminate use in food products.

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13. Cannabidiol (CBD) – Not GRAS

  • Used In: CBD-infused snacks and drinks
  • Health Concerns: Liver toxicity, drug interactions
  • FDA Verdict: Denied GRAS status in 2023

Though widely available in supplements and oils, CBD is not legally allowed in food due to concerns over long-term health effects.

14. Kava – Not GRAS

  • Used In: Herbal teas and relaxation drinks
  • Health Concerns: Liver toxicity, neurological effects
  • FDA Verdict: Not approved for food use

Despite its use in traditional Pacific Island culture, Kava was rejected by the FDA due to strong evidence of liver toxicity in humans.

15. Red No. 3 – Pending Ban (2024)

  • Used In: Candy, frostings, cereals
  • Health Concerns: Linked to cancer in animal studies
  • FDA Verdict: Proposed for removal in 2024

Though banned in cosmetics since 1990, Red No. 3 remained legal in food until new petitions forced its review.

What Does This Mean for Consumers?

The removal of these 15 substances from the GRAS list signals a growing shift toward stricter food safety regulations. However, the GRAS loophole still allows companies to self-certify new additives, meaning consumers must stay vigilant.

How to Protect Yourself:

Read labels carefully – Many food additives are still poorly regulated
Choose whole, unprocessed foods – Avoid ultra-processed items with artificial ingredients
Follow food safety updates – The FDA continues to review questionable additives

The food industry is constantly evolving, and while many harmful additives have been phased out, the fight for transparency and consumer safety is far from over.

Final Thoughts

As more scientific studies emerge, we can expect further scrutiny of food additives once considered safe. While some of these bans were precautionary, others were the result of serious, long-term health concerns.

With growing awareness, consumers have more power than ever to demand safer food and better labeling practices. The question remains: how many more “GRAS” ingredients will eventually be proven unsafe?

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Dave Soulia | FYIVT

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