# FDA WARNING_LETTER - BioMD Plus LLC - February 28, 2022

Source: https://www.keypedia.com/records/warning_letter/biomd-plus-llc/7c73c09e-6f4f-45a8-b1e7-339c0fdae79f

> FDA WARNING_LETTER for BioMD Plus LLC on February 28, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: BioMD Plus LLC
- Inspection Date: 2022-02-28
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On May 4, 2022, the FDA issued a Warning Letter to Jonathan Levitt regarding products sold on www.biomdplus.com and associated social media. The FDA reviewed the website in February 2022 and found that the company sells human and animal products containing CBD or Delta-8 THC.

The FDA determined that the human products, including "CBD Oil," "CBD Capsules," "Vegan CBD Gummies," "CBD Pain Relief Cream," "Delta 8 THC Gummies," and "Delta 8 THC Vape Cartridge," are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act. These products are also misbranded drugs under section 502(f)(1) due to inadequate directions for use. The "Delta 8 THC Gummies" are additionally considered adulterated food under section 402(a)(2)(C)(i) because Delta-8 THC is an unsafe food additive, not generally recognized as safe (GRAS).

The "Natural Pet CBD Oil" is classified as an unapproved new animal drug, unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. The FDA cited numerous claims from the company's website and social media, such as treating stress, depression, psychosis, Alzheimer's, Crohn's disease,

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Company: https://www.keypedia.com/companies/biomd-plus-llc/97a40224-a25e-40dd-86be-dfa2b98551cd

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