New ‘GRAS’ food rule: What the proposed change could mean for you

As you walk through the grocery store and toss a box of cereal or a bottle of salad dressing into your cart, it’s natural to assume these items are safe. After all, if a product is sitting on a supermarket shelf, a regulatory agency must have vetted all of its ingredients first. Right?

Not exactly. For decades, food manufacturers themselves have been allowed to determine whether many of the food chemicals and ingredients in their products are safe for people—often with zero input or oversight from the U.S. Food and Drug Administration (FDA), the federal agency charged with protecting our food supply.

But a recent proposal from the FDA could be a first step towards addressing this loophole. Under the proposed change, food companies would be required to notify the agency whenever they independently decide an ingredient qualifies under the “Generally Recognized as Safe” (or GRAS, for short) designation.

What does GRAS mean?

GRAS is a designation for substances generally recognized as safe, exempting these ingredients from being subject to the same premarket review and approval by FDA as other food additives. The rule dates back to 1958, when lawmakers created the GRAS designation to allow companies to skip lengthy FDA reviews for simple ingredients such as baking soda, vinegar and flour.

Over the decades, this exception for common household staples that didn’t require rigorous pre-market safety testing grew into a massive regulatory loophole. It’s estimated that food manufacturers have routinely used the GRAS process to quietly introduce at least a thousand substances including thickeners, extracts, flavorings and sugars into the U.S. food supply, without having to notify federal regulators or produce any scientific evidence of their long-term safety.

What do the proposed GRAS rule changes mean for me?

Under the newly proposed rule, food companies would be required to tell the FDA about new ingredients they plan to use. The FDA would also expand its public database, making it easier for shoppers to see which additives are hidden inside ultra-processed foods. This expanded database would give regulators the necessary data to flag and challenge suspect new additives faster.

That said, the proposed rule fails to address the root of the problem, as it doesn’t close the loophole the food industry has been taking advantage of. Worse, companies would still be allowed to decide for themselves if a new ingredient is safe and begin selling it in products while the FDA’s review is still pending.

Meaningful reform of the GRAS framework extends well beyond compulsory notifications. To genuinely protect public health, the policy needs rigorous, evidence-grounded safety benchmarks and mandatory, impartial FDA evaluation prior to any new chemical entering the food supply. Furthermore, regulators must reassess the vast backlog of existing market additives that have gone decades without substantive scientific scrutiny.

How do refined carbohydrates play in?

Former FDA commissioner David Kessler has petitioned the FDA to rescind GRAS status for refined carbohydrates, which are grains and sugars that have undergone heavy industrial processing to strip away natural fiber, vitamins and minerals. High-fructose corn syrup, maltodextrin, dextrose and other refined carbohydrates are treated as inherently safe under GRAS rules, despite modern scientific evidence linking their consumption to health issues in people.

Because GRAS allowed these ingredients to flood the market without formal evaluation from the FDA, refined carbohydrates are the backbone of modern ultra-processed foods. Ultra-processed foods now account for roughly 58% of the average American’s daily calories. The consequences of this oversight are written across our nation’s health statistics:

• roughly 74% of American adults are overweight or obese,
• about 38% of young adults are insulin-resistant or prediabetic,
• nearly one in three adolescents ages 12 to 17 already meet the clinical criteria for prediabetes, and
• only 12.2% of American adults are considered metabolically healthy.

Take action to get our food supply back on track

While the proposed rule change is a tiny step in the right direction, fixing the fundamentally flawed GRAS framework requires the elimination of self-certification loopholes that let manufacturers approve chemical additives without notifying the FDA in the first place. It also requires proving a food item is safe before selling it to consumers.

Staying informed by reading labels is essential, but holding regulators accountable to higher safety standards is what ultimately changes our food supply. You can take action by telling the FDA to rescind GRAS status for refined carbohydrates today.