FDA WARNING_LETTER - The Philosopher's Stone, LLC - March 12, 2021

On March 12, 2021, the FDA issued a Warning Letter to Kristopher Eickhoff regarding e-liquid products manufactured and sold via https://www.tpsvapor.com. The FDA determined that Chrysopoeia Craft E-liquid, Metamorphosis Craft E-liquid, and Transmutation Craft E-liquid are "new tobacco products" under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) because they were not commercially marketed in the U.S. as of February 15, 2007.

These products are in violation of the FD&C Act because they lack the required premarket authorization order under section 910(c)(1)(A)(i) (21 U.S.C. § 387j(c)(1)(A)(i)) and are not otherwise exempt. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information under section 905(j) was not provided.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 60 listed products, to ensure compliance with all applicable FD&C Act provisions and FDA regulations (21 C.F.R.