FDA WARNING_LETTER - Buzzagogo, LLC - January 24, 2023

On January 18, 2023, the FDA issued a Warning Letter to Joyce Dales regarding "Allergy Bee Gone for Kids" sold on buzzagogo.com. The FDA reviewed product labeling in August 2022 and determined the product is an unapproved new drug under section 505 of the FD&C Act, 21 U.S.C. 355. Claims on the website establish its intended use as a drug, despite being labeled as homeopathic.

Furthermore, FDA laboratory analysis of a sample of "Allergy Bee Gone for Kids" (lot 2006491) revealed contamination with bacillus sp., including pathogenic *B. cereus*, *B. amyloliquefaciens*, and *B. atrophaeus*. Total aerobic microbial counts ranged from 50 to 770 CFU/mL, and yeast and mold counts from 5 to 70 CFU/mL. This contamination, particularly concerning for a nasal swab product intended for young children, renders the product adulterated under section 501(a)(1) of the FD&C Act, 21 U.S.C. 351(a)(1), as it consists of a filthy, putrid, or decomposed substance.

Introducing or delivering this product into interstate commerce violates section 301 of the FD&C Act, 21 U.S