The sneaky way companies get new chemicals into our food

What It Covers

Planet Money investigates how a Peruvian plant-based protein called Terra Flower entered the U.S. food supply without FDA knowledge, poisoned hundreds of people, caused 42 gallbladder removals, and exposed the GRAS loophole that allows companies to self-certify new chemical additives as safe without government review.

Key Questions Answered

• •The GRAS Loophole Scale: 99% of chemicals currently in U.S. food entered through the GRAS (Generally Recognized As Safe) exemption rather than formal FDA review. Over 24 years, roughly 900 new chemicals were added to food; only 10 went through official FDA approval. The loophole, originally designed for common ingredients like sugar and flour, now functionally replaces the law it was meant to supplement.
• •Secret GRAS — Door Three: Beyond the standard GRAS self-certification, companies can use "secret GRAS," where they make no notification to the FDA whatsoever. Terra Flower entered the U.S. food supply this way. Consumers can protect themselves by checking ingredient lists for unfamiliar plant-derived proteins or novel additives, particularly in meal-kit and health-food products marketing high-protein plant ingredients.
• •The "Take-Back" Provision: When a company voluntarily notifies the FDA under GRAS and the FDA raises safety concerns, the company can legally withdraw its notice, halt the review, and still use the ingredient in food anyway. This means FDA concern alone carries no enforcement power — companies face zero legal obligation to address flagged safety questions before putting additives on shelves.
• •Private Litigation Fills the Regulatory Gap: Food safety attorney Bill Marler recovered $32 million across 450 Terra Flower victims because lawsuits grant subpoena power, sworn depositions, and document production under perjury penalties — tools the FDA lacks without a formal enforcement action. Consumers harmed by novel food additives should document product lot numbers, retain packaging, and seek legal counsel, as litigation currently outpaces regulatory accountability.
• •Long-Lag Additives Pose Greater Risk: Immediate-reaction cases like Terra Flower are traceable. The harder problem involves additives with chronic, delayed effects — partially hydrogenated oils were GRAS-approved for decades before the FDA revoked their status, estimating removal could prevent thousands of annual heart attacks. Consumers reducing processed food exposure across multiple product categories lower cumulative additive intake and reduce long-term chronic risk.