FDA WARNING_LETTER - hbb, llc

The FDA issued a Warning Letter to HBB, LLC dba Baked World regarding their "Lazy Larry" product (formerly "Lazy Cakes"). The product is deemed adulterated under section 402(a)(2)(C) of the FDCA because it contains melatonin, an unapproved food additive.

The FDA determined that "Lazy Larry" is a conventional food, not a dietary supplement, despite labeling claims. This classification is based on marketing alongside snack foods, the product URL referring to "cakes," website descriptions comparing it to brownies, and its appearance and ingredients consistent with a brownie.

Melatonin is not authorized for use in conventional foods by any food additive regulation, nor is it subject to prior sanction or generally recognized as safe (GRAS). The FDA found no basis for GRAS status for melatonin in conventional foods, citing a lack of scientific data to establish its safety and scientific literature raising concerns about its effects on blood glucose, reproductive/developmental, cardiovascular, ocular, and neurological systems.

Therefore, melatonin in "Lazy Larry" is an unsafe food additive, rendering the product adulterated. HBB, LLC is required to take prompt action to correct this violation and prevent recurrence. They must respond in writing within fifteen days, detailing corrective steps, supporting documentation, and a timeline for completion if corrections are ongoing. Failure to comply may result in enforcement actions, including product seizure and injunctions.