# FDA WARNING_LETTER - M Six Labs, Inc. - May 04, 2022

Source: https://www.keypedia.com/records/warning_letter/m-six-labs-inc/29de2baf-0393-4ee5-b70b-d0d92891ffd9

> FDA WARNING_LETTER for M Six Labs, Inc. on May 04, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: M Six Labs, Inc.
- Inspection Date: 2022-05-04
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On May 4, 2022, the FDA issued a Warning Letter to Terry Maxwell of m6labs.com after a February 2022 website review revealed the sale of unapproved and misbranded CBD and Delta-8 THC products for human and animal use.

For human products, the FDA determined that various CBD and Delta-8 THC items, including tinctures, balms, chews, and crystals, are unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, as they are not generally recognized as safe and effective for their intended uses (e.g., disease treatment, affecting body function). These products are also misbranded under section 502(f)(1) due to inadequate directions for use.

Additionally, several human food products containing CBD or Delta-8 THC, such as "Nobel Hemp CBD Snapping Rocks" and "Silver Lake Delta 8 Infused Sugar," are deemed adulterated under section 402(a)(2)(C)(i) because CBD and Delta-8 THC are unapproved and unsafe food additives, lacking GRAS status. Introducing these foods into interstate commerce is prohibited under section 301(ll) and 301(a).

For animal products, "Magnolia Botanicals MB Pets Hemp Oil" and "Nobel Hemp Pet Comfort Tincture" are classified as unapproved

## Related Officers

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Company: https://www.keypedia.com/companies/m-six-labs-inc/d1b807af-b5b1-42ea-aace-bac5a0a3b9d7

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c