FDA WARNING_LETTER - Breazy Inc. - July 20, 2020

The FDA issued a Warning Letter to Andres Aranda concerning the website https://www.breazy.com, which offers electronic nicotine delivery system (ENDS) products for sale in the U.S. These products are regulated as tobacco products under the FD&C Act and require premarket authorization if they are new tobacco products (not commercially marketed before February 15, 2007). The FDA's review identified that Breazy.com offered specific ENDS products, including Baset Thor, Osiris Thor, Raa Thor, and Unicorn Frappe – Juice Man E Liquid, without the necessary marketing authorization orders. As a result, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the failure to provide required information under section 905(j). The letter also highlighted particular concern regarding "Unicorn Frappe – Juice Man" for its youth-appealing graphic images, which could encourage unlawful sales to individuals under 21 and exacerbate public health risks. The firm must promptly correct all violations, cease the violative labeling, advertising, sale, and distribution of these products, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Non-compliance may lead to further regulatory actions, including detention and refusal of admission for imported products.