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.
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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