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

Source: https://www.keypedia.com/records/warning_letter/the-philosophers-stone-llc/4f821278-ba71-4aaf-bb54-0064caebb5e3

> FDA WARNING_LETTER for The Philosopher's Stone, LLC on March 12, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: The Philosopher's Stone, LLC
- Inspection Date: 2021-03-12
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: 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.

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Amy E. Wesner](https://www.keypedia.com/people/amy-e-wesner/7834c6d5-43a8-4faa-aa67-0b7da4e78d26)

Company: https://www.keypedia.com/companies/the-philosophers-stone-llc/d9334b2e-c544-4235-85ee-ae068d7bcadd

Office: https://www.keypedia.com/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374