The FDA said it had concluded that BVO was not safe for use after the results of studies, it conducted in collaboration with the National Institutes of Health, found the potential for adverse effects in humans.
The agency had first proposed to revoke the regulation in November 2023. According to the Center for Science in the Public Interest, BVO was banned in the UK in 1970, followed by India in 1990, the EU in 2008 and Japan in 2010.
Everything that the FDA doesn’t declare as “known” or “proven” safe within defined limits are “considered” safe or may be allowable to a defined limit. It is their cute little scapegoat should a substance they allow be proven unsafe and then they would face a greater risk of lawsuit had they determined it was known or proven safe.