Thioctic Acid
Thioctic (alpha-lipoic) acid is sold as a dietary supplement. EFSA evaluated its use and concluded that high intakes (>800 mg/day in some studies) are associated with adverse effects including hypoglycemia and rare insulin autoimmune syndrome; it is not authorized as a food additive in the EU.
What it is
Alpha-lipoic acid (ALA), a sulfur-containing fatty acid acting as an antioxidant cofactor.
Used as a dietary supplement ingredient and antioxidant; not a typical food additive.
Why it's flagged
- hypoglycemia risk at high doses
- reports of insulin autoimmune syndrome
- not authorized as EU food additive
What regulators actually say
"EFSA Panel on Food Additives and Flavourings published a scientific opinion on the safety of alpha-lipoic acid as a novel food."
"NIH Office of Dietary Supplements maintains fact sheets on dietary supplement ingredients including alpha-lipoic acid."
Regulatory status
United States — FDA
Sold as dietary supplement under DSHEA; not approved as a general food additive.
European Union — EFSA
EFSA assessed alpha-lipoic acid in food supplements; not authorized as a food additive.
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