Is Beta-Carotene banned?
Beta-Carotene is permitted by the US FDA. Several countries restrict, warning-label, or have reviewed it for safety concerns. The US has more lenient additive rules than the EU, UK, Canada, and Japan, which is why this ingredient remains widely used here.
Why Beta-Carotene is flagged
Beta-carotene from food is considered safe and beneficial. However, high-dose beta-carotene supplements (25 mg/day and above) were associated with increased lung cancer risk in two major clinical trials — ATBC (1994) and CARET (1996) — specifically in heavy smokers and asbestos-exposed workers. Food-level exposure from coloring use is far below supplemental doses. Harmless skin yellowing (carotenemia) can occur with very high dietary intake. As a food additive colorant, no significant safety concerns exist.
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