In a recent important proposal, the US Food and Drug Administration (FDA) announced a ban on the use of brominated vegetable oil (BVO) in food and continued to assess the safety of other chemical substances. Behind this proposal is a deep concern for human health and well - being, as well as the progress of scientific research. Below, we will delve into the legal background and potential impact of this policy change.
The FDA has extensive legal powers to regulate in accordance with the Federal Food, Drug, andCosmetics & Personal CareRegulated under the FD&C Act to ensure food safety in the US market. Under this act, any food additive must obtain FDA approval before use. FDA defines food additives as any substance intentionally added during food processing - these substances may serve purposes including improving food color, flavor, shelf life, etc.
Brominated vegetable oil was once classified as a substance Generally Recognized As Safe (GRAS), but over time, concerns have arisen about the safety of BVO. Recently, the FDA conducted a priority review of BVO usage under Section 170.3 of 21 CFR, which stipulates safety evaluation procedures for food additives. FDA scientists assess the potential health risks of chemical substances based on available data and consider whether to prohibit or restrict their use in food.
The legal action in California to ban the use of BVO foreshadowed the regulatory changes across the country. According to California regulations, the ban on the use of certain chemical substances is based on concerns about the potential health problems these substances may cause. Now, the FDAs proposal extends this ban to ensure that all US consumers do not ingest substances considered to have potential health risks.
In addition to BVO, the FDA is also re-evaluating the use of FD&C Red No. 3. According to Section 74.303 of 21 CFR, this color additive is specifically approved for coloring food, drugs, and cosmetics. However, under Section 409(b)(3) of the FD&C Act, any food additive found to reasonably cause cancer must be banned. Therefore, the FDA is assessing the risks of FD&C Red No. 3 based on the latest scientific evidence and regulatory framework.
As scientific research progresses, legal rules must also evolve to reflect new understandings and protect consumers from potential chemical risks. This proposal by the FDA is an important exercise of its regulatory function.
For more details, please refer to:FDA Proposes to Ban Food Additive, Continues Assessments of Additional Chemicals
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