FDA moves to extend its packaging-chemical exemption to ingredients added to food

The test the expanded exemption would apply is a phrase. Under the proposed text, "any substance used in food (both directly or indirectly added) will be exempted from regulation as a food additive" if there is "no appreciable risk to human health" ^[8]. Advocates quoted by the Guardian say the weakness is in how "appreciable risk" is defined ^[9]. Perchlorate, some phthalates, some bisphenols, some PFAS and some flame retardants are not classed as carcinogens, they say, but can cause harm at doses far below 0.5 parts per billion ^[9]. They also say the rule ignores the combined effect of many small doses and lets carcinogens through when they form as impurities ^[10].

The low-dose premise draws the sharpest objection. "The FDA and industry have this position that if there's only a little bit of something in the diet, then it's not going to be problematic, but that isn't supported by science of any kind," said Maricel Maffini, an independent food consultant who has worked on TOR issues ^[12]. "I don't know how they're going to square that circle because there are many ingredients that at very low levels also cause serious issues in the body," she said ^[13]. Her particular concern is flavourings, where she said manufacturers use chemicals that "play around with the nervous system and receptors in your mouth to try to make us eat more and more of something" ^[17]. The FDA did not respond to the Guardian's request for comment ^[15].

Maria Doa, a scientist with the Environmental Defense Fund, went after the agency's framing directly. "They're widening another loophole, but trying to say they made our food safer," she said. "They did not make our food safer." ^[14] Some advocates have accused Robert F Kennedy Jr of deception over the omission, the Guardian reported ^[18].

For a food company, we think the trade-off is formulation speed now against defensibility later. Advocates call the proposal a major win for big food and say it rests on flawed science ^[16]. An ingredient that skips a federal safety review gets into production sooner ^[3]. If its safety is questioned years on, the company that chose it is defending a decision the agency never examined. The Guardian's report does not address who would bear legal liability in that case. We do not know yet whether the FDA will tighten "appreciable risk" before any final rule.

These exemptions last. BASF used the threshold in 2005 to clear perchlorate for "super sacks", the one-ton polypropylene bags used to move rice, flour and oats ^[1]. The exemption still allows the chemical in grain bags ^[2]. The proposal is not yet final ^[3], so this quarter's question is whether to plan formulations around a standard the FDA has not defined. If the rule is finalised, next year's question is what it costs to take exempted ingredients back out once they are written into supplier specifications.