Caffeine
FDA cites 400 mg/day as generally safe for healthy adults. However, pregnancy, children, and individuals with cardiovascular conditions face documented harm at typical intake levels — ACOG recommends <200 mg/day during pregnancy, and EFSA has set lower thresholds for children.
What it is
A naturally occurring methylxanthine alkaloid (1,3,7-trimethylxanthine) and central nervous system stimulant.
Stimulant; flavoring agent; occurs naturally in coffee, tea, cacao; added to colas and energy drinks.
Why it's flagged
- Pregnancy: increased miscarriage/low-birth-weight risk above 200 mg/day
- Cardiovascular: arrhythmia risk in susceptible individuals
- Dependence and withdrawal
- Children: EFSA sets lower exposure thresholds
What regulators actually say
"For healthy adults, the FDA has cited 400 milligrams a day—that's about four or five cups of coffee—as an amount not generally associated with dangerous, negative effects."
"For pregnant women, caffeine intake from all sources up to 200 mg per day consumed throughout the day does not give rise to safety concerns for the fetus."
"Caffeine - GRAS for use in cola-type beverages at a level not to exceed 0.02 percent."
Regulatory status
United States — FDA
GRAS in cola-type beverages up to 0.02% (200 ppm) under 21 CFR 182.1180; warning issued for pure/highly concentrated caffeine products.
European Union — EFSA
Single doses up to 200 mg and habitual intake up to 400 mg/day do not raise safety concerns for healthy adults; 200 mg/day for pregnant women.
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