FDA WARNING_LETTER - Sambrosa Care Inc. - January 30, 2024

The FDA issued a Warning Letter to Dr. de Wit regarding the firm's distribution of "Sambrosa sweet dreams Night Syrup," an over-the-counter (OTC) combination antihistamine and nighttime sleep-aid. The product is cited as an unapproved new drug and misbranded, violating sections 505(a), 502(ee), 301(d), and 301(a) of the FD&C Act.

The product is deemed a "drug" due to claims on its label and website (sambrosa.com) indicating its use for allergy symptoms (sneezing, runny nose, itchy eyes/throat) and as a sleep aid. The FDA states the product is an unapproved new drug because it does not conform to the conditions of Over-the-Counter Monograph M012 (Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products) or M010 (Nighttime Sleep Aid Drug Products). Specifically, the doxylamine succinate dosage (9.78 mg per 3 mL, up to 114.1 mg daily) exceeds the maximum allowed under M012 for both children (37.5 mg) and adults (75 mg). Additionally, the product contains unapproved active ingredients like honey, California poppy, hawthorn, hops, mistletoe, passion flower, oats, and white chestnut, which are not recognized