The FDA is proposing to widen a "threshold of regulation" (TOR) exemption so that certain chemicals could be added directly to food as flavorings, preservatives, enzymes, stabilizers or other ingredients without formal food-additive review, provided they aren’t classified as carcinogens and pose "no appreciable risk" at very low levels. Critics warn this would let substances known to disrupt hormones, harm developing brains, impair immune function, alter microbiota or persist in the environment - including perchlorate, some phthalates, bisphenols, PFAS and flame retardants - enter ultra-processed foods at concentrations that science shows can be harmful well below 0.5 parts per billion. The rule also ignores cumulative exposures, allows carcinogenic impurities, offers no consumer disclosure, and was quietly bundled into a broader move touted as closing the GRAS loophole, prompting accusations of deception by FDA leadership and charges that the change favors industry over public health.
Campaigners point to a concrete precedent: a 2005 TOR exemption for perchlorate used in industrial grain bags coincided with higher perchlorate levels in children’s cereal, which impairs thyroid hormone production essential for brain development. Investigations found hundreds of substances have exploited the GRAS pathway to reach the market, and critics say the proposed TOR expansion repeats past regulatory failures by relying on flawed assumptions about "safe" low-dose exposures and by aligning with an administration philosophy resistant to stricter oversight.
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