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FDA proposes new food ingredient rule, but definition of 'ultra-processed' is delayed

Created at 10 Aug · 3:56 PM1 source↑ Market-relevant
IN SHORT

The FDA has proposed a rule requiring manufacturers to notify the agency of all food ingredients used under the Generally Recognized As Safe (Gras) pathway. However, the administration has postponed defining 'ultra-processed foods,' a move criticized by experts.

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Key Numbers

1958year Gras framework was put in place
10,000confirmed cases of cyclosporiasis in current outbreak

Who's Involved

US Food and Drug Administration (FDA)
proposed new food ingredient notification rule
Marion Nestle
professor emerita of nutrition, food studies, and public health at New York University
Kyle Diamantas
acting commissioner of the FDA
Amaru Sanchez
food and agriculture lawyer at Akin Gump Strauss Hauer & Feld
Robert F Kennedy Jr
secretary of the US Department of Health and Human Services (HHS)

↳ Why This Matters

The FDA's proposed rule aims to enhance transparency and safety in the food supply chain by mandating ingredient notifications, while the delay in defining 'ultra-processed foods' leaves consumers and researchers without a clear standard for evaluating food healthiness.

Key facts

  • The FDA has proposed a new rule requiring mandatory notification of all food ingredients used under the Generally Recognized As Safe (Gras) pathway.
  • This proposed rule aims to close a loophole that allowed companies to introduce new ingredients without formal FDA submission.
  • The Trump administration has deferred the release of a definition for 'ultra-processed foods'.
  • The Gras framework, established in 1958, has become a primary route for new substances entering the US food supply.
  • The FDA will also issue new guidance on biological hazards in fresh-cut produce.
  • The US Food and Drug Administration (FDA) has proposed a new rule that would require food manufacturers to formally notify the agency of all ingredients used in their products under the Generally Recognized As Safe (Gras) pathway. This move aims to close a long-standing regulatory loophole that has allowed new substances to enter the US food supply without rigorous review.

    However, the administration has once again delayed the release of a definition for 'ultra-processed foods,' a highly anticipated announcement that experts say is crucial for transparency in the food system. Marion Nestle, a professor emerita at New York University, expressed frustration, questioning the delay for such a seemingly simple definition.

    The proposed rule, submitted to the Federal Register, would transform the Gras framework, established in 1958, from a voluntary system to a mandatory notification process. Kyle Diamantas, acting commissioner of the FDA, stated on a press call that this change would apply to both existing and new ingredients.

    Amaru Sanchez, a food and agriculture lawyer, described the proposal as a significant development for the food industry, though he raised questions about the FDA's regulatory authority to mandate such notifications, especially in light of recent legal decisions. The FDA also plans to release new guidance on biological hazards in ready-to-eat fresh-cut produce.

    Experts like Nestle noted that while mandatory notification is an improvement, companies would still be responsible for proving the safety of their ingredients, and the FDA would face increased strain in reviewing these submissions. The agency has yet to clarify the process for when it rejects a company's safety proof. The delay in defining 'ultra-processed foods' comes amid ongoing large-scale foodborne illness outbreaks in the US, including cyclosporiasis and salmonella.

    Frequently asked questions

    The FDA is proposing to require food manufacturers to formally notify the agency of all ingredients used under the Generally Recognized As Safe (Gras) pathway, shifting from a voluntary to a mandatory system.

    The Gras framework, established in 1958, has become the primary method for new substances to enter the US food supply, often bypassing the more stringent food additive petition process.

    The definition has been postponed, with the FDA stating that it is difficult to ascertain and that further information will be shared at a later date.

    Questions remain about the FDA's legal authority to mandate notifications and the process for handling rejected ingredient safety proofs. Experts also note that companies will still be responsible for proving safety.

    What Happens Next

    01The FDA will publish new guidance on biological hazards in ready-to-eat fresh-cut produce.
    02Additional information on ultra-processed foods will be shared at a future time.

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    Cadence

    How It Developed

    The FDA submitted a proposed rule to the Federal Register on Monday.
    The rule requires companies to submit all ingredients used under the Gras pathway to the FDA.
    The proposed rule aims to transition the Gras framework from a voluntary to a mandatory notification system.
    The administration has delayed providing a definition for 'ultra-processed foods'.
    The FDA will also publish new guidance on biological hazards in ready-to-eat fresh-cut produce.

    Sources

    T1
    FDA proposes new food ingredient rule but skips defining ‘ultra-processed’The Guardian

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