Dimethylaminoethanol Tartrate
DMAE is not approved by the FDA as a food additive or drug; it remains marketed as a dietary supplement under DSHEA without recognized GRAS status. Animal studies have raised concerns about possible developmental toxicity and neural-tube effects, and it is not authorized in the EU as a Novel Food.
What it is
DMAE bitartrate (deanol bitartrate), the tartrate salt of dimethylaminoethanol, a substance marketed in supplements and topical cosmetics.
Not a recognized food additive; used in dietary supplements and topical skin products.
Why it's flagged
- Animal studies suggest possible developmental/neural-tube toxicity
- No established human safety dose
What regulators actually say
"DMAE may induce neural tube defects... Pending further investigation, the use of DMAE during pregnancy should be avoided."
Regulatory status
United States — FDA
Not GRAS, not approved as food additive; sold as dietary supplement under DSHEA
European Union — EFSA
Not authorized as a Novel Food in the EU
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