Betaine
Betaine has an authorized EFSA health claim for normal homocysteine metabolism (1.5 g/day). EFSA approved anhydrous betaine as a Novel Food.
What it is
Trimethylglycine, a naturally occurring compound found in beets, spinach, and whole grains; also synthesized.
Functional ingredient and dietary supplement; methyl donor with role in homocysteine metabolism.
Why it's flagged
- high supplemental doses (>4 g/day) may increase total cholesterol/triglycerides
What regulators actually say
"A cause and effect relationship has been established between the consumption of betaine and contribution to normal homocysteine metabolism."
"The Panel concluded that betaine is safe under the proposed conditions of use as a Novel Food."
Regulatory status
United States — FDA
Betaine anhydrous is an FDA-approved drug (Cystadane) for homocystinuria; food/supplement use as GRAS notified.
European Union — EFSA
Approved as Novel Food (Reg. 2017/2470); authorized health claim for homocysteine.
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