FDA WARNING_LETTER - Morin Enterprises Inc. d/b/a Ecig Crib - March 30, 2021

The FDA issued a Warning Letter to Kevin Morin, Debra Morin, and Amy Harris of ecigcrib.com on March 26, 2021, following a review of their website. The FDA determined that e-liquid products, specifically "E Cig Crib - Planet of the Grapes E Liquid" and "E Cig Crib - Cotton Candy E Liquid," are manufactured and offered for sale in the U.S. 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 the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. These e-liquids were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required information under section 905(j) was not provided.

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money