Like other compounds sold as dietary supplements, melatonin doesn’t need premarket approval by the Food and Drug Administration when sold in pill form. But used as a food additive, it would likely be subject to FDA regulation. That’s why the makers of the new melatonin-spiked brownies are marketing their products as dietary supplements — not food.
Lazy Cakes are a combination OTC sleeping pill with a high dose of melatonin and unknown amounts of sleep inducing substances like valerian root and passion flower.
From a public health standpoint, Lazy Cakes will be eaten by children and adolescents, probably regarded as something potentially “cool”; will be used by all age groups as a sleeping pill, sometimes unwittingly; will be utilized to “come down” from high caffeine/amino acid content energy beverages, and will likely be mixed with other medications.