Vitamin B8
Biotin (B7/B8) is essential and non-toxic at supplement doses; very high doses can interfere with laboratory immunoassays (FDA safety communication). Inositol is well tolerated at typical food/supplement levels.
What it is
Older European designation referring either to biotin (vitamin B7 in US nomenclature) or to inositol; both are water-soluble vitamins/vitamin-like substances.
Fortificant/nutrient added to foods, infant formula, and supplements.
Why it's flagged
- high-dose biotin can cause clinically significant lab test interference (FDA warning)
What regulators actually say
"Biotin in blood or other samples taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically significant incorrect lab test results."
"Biotin (vitamin B7) is a water-soluble B-vitamin; no toxicity has been reported in humans at the levels found in food and supplements."
Regulatory status
United States — FDA
Permitted nutrient/fortificant; biotin GRAS as nutrient (21 CFR 184.1140 for pantothenic-related items; biotin GRN-affirmed).
European Union — EFSA
Approved nutrient under Regulation 1925/2006 (addition of vitamins and minerals to foods); UL not established.
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