FDA WARNING_LETTER - Little House Vapes, LLC - January 15, 2021

On January 15, 2021, the FDA issued a Warning Letter to Chris Lecompte of Little House Vapes, LLC, following a review of their website, https://littlehousevapes.com. The FDA determined that e-liquid products, including "Sweet Sin" and "Honeydew Melon," were manufactured and offered for sale or distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is that these e-liquid products are "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 13,100 listed products, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141