It has been a while since I posted about a food additive but I feel that this issue is important enough to blog about as it is a final step after a long debate about the safe use of BVO. Today, on the Federal Register’s (FR) pre-publication page (here), there is a proposed rule to revoke the use of BVO in food.
The use of BVO as a food ingredient is intended to stabilize flavoring oils in fruit-flavored beverages. There are no authorizations for other uses of BVO in food. The FDA says, “[T]his action is being taken because there is no longer a reasonable certainty of no harm from the continued use of BVO in food.”
The FR notice cited above provides the history of the FDA’s actions regarding BVO, from its decision in 1970 to grant GRAS status to the ingredient for use in food as well as subsequent decisions regarding what might be considered safe levels to permit the continued use of BVO (from an original permitted level of 150 PPM down to a permitted use level of 15 PPM) while awaiting the submission of scientifically valid data supporting its continued safe use. The history reveals a long pause on any regulatory action as the FDA waited for data.
As part of the FDA’s reevaluation of food additive ingredients, which began in 2014, the Agency identified four unresolved safety issues regarding the use of BVO in food:
- the potential for thyroid toxicity
- developmental neurotoxicity, and
- reproductive toxicity
The FDA was not happy with the data to make any kind of final decision regarding the disposition of BVO so it commissioned a well-designed rodent study to be conducted by the National Center for Toxicological Research (NCTR). “The rodent safety studies conducted by NCTR were published in 2022 and confirmed previous reports that dietary exposure to BVO is toxic to the thyroid and results in bioaccumulation of lipid-bound bromine in the body at doses relevant to human exposure.” Because this study was sufficient for taking action to remove BVO for use in food, the Agency concluded that there was no reason to conduct additional studies to assess the other two unresolved issues.
With other, more recently permitted food additives available to replace it, the Agency published this proposed rule to begin the process for finalizing a decision. While the use of BVO by manufacturers has been substantially reduced over time in favor of other ingredients, the Agency has set in motion the final process for eliminating the use of BVO in foods.
Well, it’s been a long time in coming and there is still a wait until final action can be taken. There will be a 75-day comment period after the proposed rule is published tomorrow. The FDA says that it will not accept comments after that date. The comments will then be reviewed and, hopefully, the final rule will be published shortly after that.