If anyone has doubted that the regulation of a single state could impact the nation, it’s time to think again …
In the wake of California’s October banning of brominated vegetable oil (BVO) in food, the FDA has followed suit, proposing to revoke the regulation authorizing its use. While the FDA BVO release explains that the agency has determined it can no longer conclude that the use of BVO in foods is safe due to studies it conducted, it seems a bit odd that its conclusion and revocation proposal would follow so closely on the heels of the California ban.
The process here creates some serious concerns around who is the leading authority. Is it a federal agency charged with keeping current around risks in foods? Or is it a state which has significantly fewer resources and is not charged with protecting public health across the entire country?
To provide a little history, BVO was recognized as GRAS in the 1950s, but questions of its safety became prevalent enough in the 1960s for FDA to remove it from the GRAS list. However, the agency did not see there being enough data to completely restrict its use. So BVO use since then has been limited to no more than 15 ppm as a stabilizer for fruit flavoring in beverages (for which it is used to keep the citrus flavoring from floating to the top). However, there also is some aspect of FDA locking the barn door after the horses have left, as most beverage manufacturers have already reformulated their products to replace BVO, with few beverages still sold in the U.S. that contain BVO. So is that why FDA did not take action on BVO earlier – because the agency determined nobody was using it?
Both California and the FDA base their actions on studies demonstrating adverse health effects of BVO, such as a bioaccumulation of bromine having toxic effects on the thyroid – a gland critical to the regulation of blood pressure, body temperature, heart rate, metabolism and the reaction of the body to other hormones. But with FDA having continued studies over the more than half a century since its BVO GRAS removal, it just strikes us as interesting that its revocation proposal would be issued less than a month after California’s signing.
In fact, FDA cites the California ban in its news release, stating, “We recognize that California recently took steps to ban the use of four food ingredients, including BVO, in that state.” It also said that the agency is continuing to assess the other three ingredients as well, with a current focus on Red dye no. 3, for which “decision from the FDA is forthcoming.”
Such FDA focus also brings to mind the October California ruling on the disclosure of test results of heavy metals in baby food. The state’s rule requires that testing for arsenic, cadmium, lead, and mercury begin in 2024, and that manufacturers post test results on their internet website beginning in 2025. That is, any product tested for a toxic element subject to an FDA action level, regulatory limit, or tolerance would have to have a QR code on its label that links to a webpage with the test results and a further link to related FDA guidance. While the rule references FDA action levels, limits and tolerances, it takes the federal guidance to the next level, not only requiring public disclosure, but making it a crime to manufacture deliver, hold, or offer for sale in the state any baby food that does not comply with the rule’s provisions.
With the widespread consumer advocacy push to reduce heavy metals in foods and FDA’s apparent following in California’s footsteps (i.e., the BVO ban) related to such regulation, we see it as likely that the agency’s gradual entry into heavy metal legislation could take a stronger stance with stricter action levels and regulatory limits. But even if the federal actions don’t take a speedier turn, selling into California continues to be increasingly complex, with manufacturers likely to apply its rules to all products, rather than trying to manufacture separately for one state.
Overall the sequence of events here is disappointing. Traditionally FDA is the “Lead Authority” in risk related to food that falls under their purview. So what happened with BVO? Is this a lack of leadership at FDA, a lack of funding, political pressure – whatever it is, there is a lack of transparency and an erosion of confidence in the agency’s ability to stay out in front of risks.