Healthcare

    The FDA Proposes Mandatory Safety Reviews for New Food Ingredients, Closing the GRAS Loophole

    A proposed rule announced Monday would end food companies' ability to self-declare new ingredients as generally recognized as safe, requiring safety data to reach the FDA before new compounds reach shelves.

    By Aaron Rafferty·WYDE Newsroom· 2 min read
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    The FDA Proposes Mandatory Safety Reviews for New Food Ingredients, Closing the GRAS Loophole

    Key Takeaways

    • The FDA proposed a rule Monday requiring food companies to notify the agency and submit safety data before selling products with new ingredients, making the voluntary GRAS notification system mandatory.

    • HHS Secretary Robert F. Kennedy Jr. said the government does not know exactly how many chemicals are in the food Americans eat every day.

    • The proposal does not touch ingredients already common in processed food, including high fructose corn syrup, and the administration again declined to define ultra-processed foods.

    The Food and Drug Administration proposed a regulation on Monday that would require food companies to tell the government when they add new ingredients to their products and to submit data demonstrating those ingredients are safe, UPI reported. The change targets a decadeslong practice in which companies could launch new compounds by declaring them generally recognized as safe, or GRAS, without any FDA review, a pathway CNN reports the agency now wants to close.

    Health and Human Services Secretary Robert F. Kennedy Jr. announced the proposal, arguing that the food industry keeps developing novel compounds and chemical combinations that do not exist in nature. "Our bodies did not evolve consuming many of these substances," he said. Under the rule, companies would have to document their safety rationale and give regulators the chance to investigate potential risks before products ship.

    The rule has clear limits. It does not address ingredients already widespread in processed food, including refined carbohydrates, high fructose corn syrup, maltodextrin and dextrose, all of which researchers have linked to chronic disease. And while announcing it, the administration again declined to define ultra-processed foods, a definition it first promised more than a year ago, Time reports. The proposal now enters a public comment period before the FDA can move toward a final rule.

    Food policy is being rewritten docket by docket this month. The farm bill failed in committee over SNAP error rates, HHS proposed erasing about 1,400 Head Start rules, and now the ingredient pipeline itself is up for comment. None of this is new on its own. What's new is how much of what Americans eat is being decided in rulemaking dockets at the same time.

    People Also Ask

    What is the GRAS loophole?

    Under current practice, companies can self-affirm that a new ingredient is generally recognized as safe and bring it to market without notifying the FDA or submitting safety data for review.

    What would the FDA's proposed rule change?

    Notification would become mandatory. Companies would have to submit their safety rationale and supporting data to the FDA before adding new ingredients, giving regulators a chance to investigate risks first.

    Does the proposal cover high fructose corn syrup or refined carbohydrates?

    No. The rule targets new ingredients, not compounds already common in processed foods, several of which are linked to Type 2 diabetes, obesity and cardiovascular disease.

    When would the new food ingredient rule take effect?

    Only after the public comment period closes and the FDA finalizes the rule. No effective date has been set, and proposals of this size typically take months or longer to finalize.

    Sources: UPI, CNN, Time

    food policyhealthcare
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