FDA WARNING_LETTER - Blue Lab Vapors, LLC - March 12, 2021

The FDA issued a Warning Letter to Fred Jeffery and Daniel Jeffrey of Bluelabvapors.com after reviewing their website and determining that e-liquid products, specifically "Madagascar" and "Peach," were being 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 key violation identified is that these e-liquid products are "new tobacco products" as they 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 necessary notice or information under section 905(j) was not provided.

The FDA emphasizes that the firm, a registered manufacturer with over 1,000 listed products, is responsible for ensuring compliance with the FD&C Act and FDA regulations. 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 actions taken to address the violations, including discontinuing the