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The Origins of GRAS: A Loophole in Food Safety
Over time, this well-intended loophole has allowed thousands of untested chemicals into the food supply without direct FDA oversight.
The Generally Recognized as Safe (GRAS) designation was created as part of the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Before this amendment, there were few regulations on what food manufacturers could add to products. The growing use of artificial preservatives and additives raised public concern, prompting lawmakers to establish a system to evaluate food ingredient safety.
The 1958 amendment required that any new food additives undergo FDA approval unless they were already recognized as safe by qualified experts. The GRAS exemption was introduced to cover ingredients like salt, vinegar, and spices—substances with a long history of safe use in food.
Key Moments in the History of GRAS
1958 – The Birth of GRAS
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The Food Additives Amendment of 1958 is passed, requiring FDA approval for new food additives.
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The GRAS exemption is created to cover ingredients with a long history of common use and safety.
1970s – GRAS Expands Beyond Its Original Intent
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Companies begin using the GRAS designation to introduce new synthetic chemicals and food additives, rather than just traditional, well-known ingredients.
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The FDA re-evaluates some previously classified GRAS substances, removing a few but leaving many untouched.
1997 – Industry Self-Regulation Takes Over
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The FDA introduces a voluntary GRAS notification system, allowing food companies to self-determine whether an additive is safe.
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Instead of requiring FDA approval, companies submit their own safety assessments, often relying on industry-funded research.
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The FDA does not independently review or test these substances, unless concerns are raised later
2010s – Growing Public Concern & Investigations
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Health and consumer advocacy groups begin exposing how thousands of new food chemicals enter the market without thorough testing.
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A 2013 Pew Research Center study finds that many GRAS decisions are made by scientists with financial ties to the food industry, raising ethical concerns.
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The Environmental Working Group (EWG) and other organizations demand FDA reform to close the GRAS loophole.
2016 – FDA Formalizes the Self-Regulation System
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The FDA finalizes the GRAS Rule, officially allowing companies to determine safety without FDA oversight.
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Companies no longer need to notify the FDA when they classify an ingredient as GRAS, meaning new chemicals can be added to food without public knowledge or review.
Today – GRAS Remains a Controversial System
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Over 10,000 food additives are now in the U.S. food supply, with thousands classified as GRAS without independent testing.
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Many substances banned in Europe, Canada, and other countries remain legal in U.S. foods due to the weak oversight of the GRAS system.
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Critics argue that industry self-regulation has created a "fox guarding the henhouse" scenario, where food manufacturers put profits ahead of consumer safety.
The Bottom Line:
What started as a well-intentioned exemption for natural ingredients has become a loophole that allows untested, synthetic chemicals into the food supply. Unlike the European Union, which applies the "precautionary principle"—banning substances until proven safe—the U.S. allows food manufacturers to decide for themselves what is safe, often without long-term studies on human health effects.
The GRAS system continues to face criticism for its lack of transparency and failure to protect consumers from potentially harmful substances lurking in everyday foods.