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FSN Daily Weekend Edition: The GRAS Debate

Hi FSN Daily readers, and welcome to this Special Weekend Edition!

Three years ago, a Daily Harvest outbreak shook consumer trust, sickening nearly 400 people across 39 states with severe gastrointestinal and liver issues. The likely culprit? Tara flour, a novel ingredient introduced under the FDA’s “Generally Recognized as Safe” (GRAS) loophole — a system letting companies self-certify ingredients as safe without mandatory FDA review.

This week’s Wednesday Weigh-In asked: “Should the FDA end self-affirmed GRAS status for food ingredients?” Over 150 responses poured in, revealing sharp divides and raw frustration. Let’s dive into what you had to say.

Here’s How You Weighed In:

  • ✅ Yes—it’ll stop unsafe additives and boost FDA oversight: 62% 

  • 🔍 Maybe, but only if fees don’t burden smaller companies: 24% 

  • 🚫 No—it’s unnecessary red tape that stifles innovation: 10%

  • 💬 Other: 4%

Closing the Loophole: A Safety Win?

The GRAS designation, designed to simplify the approval of safe food ingredients, has been criticized as a loophole that allows companies to introduce potentially unsafe additives without rigorous FDA review. A strong 62% of you supported ending the self-affirmed GRAS status, reinforcing calls for enhanced oversight.

“Self-regulation is never adequate regulation,” wrote one reader, comparing it to “letting 4-year-olds set their own bedtime.” Another, still reeling from a foodborne illness, shared: “I’ve learned the hard way that companies prioritize profit over health. Three years after a ‘secret GRAS’ product, I can’t work or eat freely.”

Readers pointed to cases like the Daily Harvest outbreak, where an unvetted ingredient led to 133 hospitalizations. “Greedy companies will skirt rules unless fines hit their bottom line,” said a respondent, calling for more FDA inspectors.

A Balanced Approach?

Twenty-four percent took a middle road, supporting reform but worrying about costs. “Smaller companies can’t afford hefty fees,” one reader cautioned. “Big players like PepsiCo will just pass costs to consumers, while startups get crushed.” Another suggested tiered regulation: “Scale oversight to company size—don’t choke innovation.”

This group sees the Toxic Free Food Act, proposed by Rep. Rosa DeLauro, as a step forward but fears it could overburden small producers. “The FDA needs to streamline, not strangle,” one wrote.

Curious about tara flour? Check out this in-depth analysis by Neal Fortin, Professor in the Department of Food Science and Human Nutrition and Director of the Institute for Food Laws & Regulations at Michigan State University, on tara flour and the GRAS framework.

Innovation at Risk?

Ten percent pushed back, arguing GRAS fuels creativity. “It’s a statutory concept—FDA’s hands are tied without Congress,” one reader noted. Another defended industry: “New ingredients drive plant-based growth. Overregulation could kill jobs.” The Consumer Brands Association has echoed this, warning mandatory reviews could stall progress.

Still, even skeptics admitted flaws. “There needs to be a framework, but blanket bans aren’t it,” one said, suggesting targeted audits over scrapping GRAS entirely.

Outside the Box

The 4% who chose “Other” brought fresh angles. One reader distrusted the FDA itself: “They’ve allowed unsafe ingredients for years—why trust them now?” Another called for global standards: “Imports dodge GRAS rules. Fix that first.” A third demanded transparency: “Publish every GRAS self-affirmation online.”

What’s the FDA doing about tara flour? See their May 2024 update.

Why It Matters

Your responses show a hunger for change tempered by practical concerns. The Daily Harvest outbreak revealed how the GRAS system can allow untested ingredients to reach store shelves — and put lives at risk. Still, some argue that reform shouldn’t come at the expense of small businesses or affordability. As one reader put it, “Safety can’t crush the little guy or jack up grocery bills.” 

Will it restore trust, or spark new battles? You tell us.

(Keep it respectful; personal attacks or ads will be removed.)

Stay tuned for next Wednesday’s Weigh-In! Until then, stay safe and informed with FSN Daily!

All the best,
Jonan Pilet, Newsletter Editor

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