FDA WARNING_LETTER - Custom Vapes - May 06, 2021

The FDA issued a Warning Letter to Custom Vapes, identifying them as a manufacturer and distributor of e-liquid products, which are deemed tobacco products under the FD&C Act. The letter states that Custom Vapes' "Amaretto 3MG 3ML 70VG/30PG e-liquid product" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that this product is being sold without the required premarket marketing authorization order from the FDA, as mandated by section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the lack of required notice or information under section 905(j). The failure to provide such a report is also a prohibited act under section 301(p).

Custom Vapes, a registered manufacturer with over 2,300 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days, detailing corrective actions, including dates of discontinued sales/distribution, and