What Happened?
The Food and Drug Administration (FDA) proposed a rule on Aug. 11 that would require companies to notify the agency about certain substances they have determined are generally recognized as safe, a category that is currently exempt from the premarket approval requirements for food additives.Under current law, companies can make that safety determination on their own without notifying the FDA at all.
The nonpartisan research arm of Congress, published a report examining whether the FDA has the legal authority to mandate those notices without new legislation.
Why Does it Matter to Me?
Under the FDA's proposed rule, the agency would have 45 days to decide whether a submission is adequate for filing, followed by a 180-day review period that could be extended twice by 90 days. During this period companies could market qualifying substances.
Under the proposal, a company's failure to submit a required notice could influence the Food and Drug Administration's enforcement priorities after products reach the market, and the agency could determine that a substance does not qualify as generally recognized as safe, which could potentially make foods containing that unapproved additive adulterated.
Both Sides, Now
Critics point to concrete failures under the current voluntary system. Tara flour, an ingredient in a Daily Harvest product, was associated with roughly 400 adverse-event reports, and the FDA later determined it was not safe. Opponents warn mandatory notification could strain FDA resources, slow innovation, or disrupt food supplies. The FDA itself stated in its 2016 final rule that it lacked express statutory authority to require submissions.
Going back more than a decade, the investigative arm of Congress concluded that the Food and Drug Administration's (FDA) oversight process did not help ensure the safety of all new "generally recognized as safe" determinations, because the agency reviewed only determinations that companies submitted through the voluntary program.
What Happens Next?
Public comments on the proposed rule are due Dec. 9. After that, the FDA could finalize the rule and defend its authority in court, where judges would independently weigh whether the statute permits mandatory notification.
Congress has introduced several proposals addressing oversight of substances companies deem generally recognized as safe (GRAS), including the GRAS Oversight and Transparency Act (H.R. 7291), the Better Food Disclosure Act (S. 3122), the Grocery Reform and Safety Act (H.R. 4958), and the Ensuring Safe and Toxic-Free Foods Act (S. 2341).
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