Introduction: What Is GRAS?
This is the Tara spinosa tree. Its seeds are commonly harvested to extract tara gum, that’s a food additive used in products like ice cream, sauces, and baked goods. Although tara gum is widely used around the world, it’s not explicitly listed by the U.S. Food and Drug Administration (or the FDA) as an approved food additive. Instead, it is used under the FDA’s "Generally Recognized as Safe" (GRAS) regulatory framework. GRAS allows certain substances to be used without formal FDA approval if they are considered safe by qualified experts.
Tara Flour and the Limits of GRAS
In 2022, a company used Tara spinosa seeds in a different way—not to extract gum, but to mill the entire seed into a novel ingredient called tara flour. This ingredient was added to a packaged food product based solely on the company’s internal GRAS self-determination, without FDA review.
Shortly after its release, nearly 400 consumers reported serious health issues, including liver dysfunction and gallbladder removal. The product was recalled, and an FDA investigation followed. In 2024, the FDA concluded that tara flour did not meet GRAS standards and deemed it an unapproved food additive.
The Legal Foundation of GRAS
The GRAS concept dates back to the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. This amendment carved out an exemption for substances that either:
Were backed by strong scientific evidence reviewed by qualified experts.
Importantly, these “qualified experts” can be internal to the company making the GRAS determination.
GRAS in Food Ingredients
GRAS substances are excluded from the formal definition of food additives, and therefore do not require premarket approval from the FDA. To qualify as GRAS, a substance must:
Be supported by publicly available safety data
Be generally recognized as safe by qualified experts
Show a reasonable certainty of no harm when used as intended
When GRAS Conflicts with Global Standards
There are several ingredients that were commonly used before 1958 and remain GRAS in the United States but are banned elsewhere.
For example, brominated vegetable oil (or BVO). This was added to the GRAS list over 50 years ago, and it has been banned in numerous countries due to potential health risks. And in July 2024, the FDA officially revoked its GRAS status.
However, being revoked doesn’t mean BVO has been entirely removed from the US food supply. According to the USDA’s FoodData Central, over 600 products still contain BVO at the time of this recording—demonstrating that GRAS is not a foolproof measure for food safety.
State-Level Pushback: California’s Skittles Ban
In 2023, California passed Assembly Bill 418, and it was nicknamed the "Skittles Ban"—which prohibited the use of several food additives still permitted under federal GRAS standards. This legislation reflects a growing trend of state-level action challenging the federal status quo on food safety.
GRAS in Packaging Materials
The GRAS concept also extends beyond ingredients to packaging materials. Any material that may come into contact with food—like coatings, adhesives, containers—must not compromise food safety.
For example, a can of soup may include a metal can, the interior coating preventing corrosion, adhesives or cements holding the seams together, and exterior labels, inks, and varnishes used in the branding.
Even though many of these components don’t directly contact the food, they must still be evaluated for safety. And in some cases, the risk of chemical migration is so minimal that full FDA food additive petitions may not be required.
GRAS But Banned Elsewhere: Phthalates in Packaging
One significant class of substances used in packaging that is GRAS in the US but is banned in other countries is phthalates. The European Union, in contrast, bans or heavily restricts phthalates in food packaging due to links to endocrine disruption and developmental toxicity.
GRAS Determination Pathways
Companies seeking to determine the GRAS status of a substance have two primary options:
Self-Determined GRAS:
This means a company conducts its own assessment to conclude that a substance is GRAS for its intended use.
And no formal FDA notification is required.
The company assumes responsibility for ensuring the safety and compliance of the substance: U.S. Food and Drug Administration.
FDA Notification (Voluntary):
The company voluntarily submits a GRAS notice to the FDA for review.
The FDA aims to respond within 180 days, with a possible 90-day extension if needed.
The FDA's response can be one of the following:
No questions regarding the GRAS conclusion.
Insufficient basis for the GRAS conclusion.
At the notifier's request, can cease the evaluation.
It's important to note that while FDA notification is voluntary, it provides an added level of oversight and can offer greater assurance to consumers and stakeholders regarding the safety of the substance.
Preparing for Legal and Regulatory Scrutiny
While the GRAS framework has not been overhauled as of April 2025, companies relying on self-affirmed GRAS status should prepare for increasing scrutiny by:
Reviewing and strengthening your safety dossiers
Ensure all supporting safety data is up-to-date and robust.Conducting additional safety studies
Especially where public health debates or new research raise concerns.Monitoring legal and regulatory changes
Be proactive in adjusting internal protocols to align with evolving standards.
If you like this lesson, it lives within our Regulations course within the Certificate of Packaging Science.
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