What happened
Original notice title
BioMD Plus LLC MARCS-CMS 618460, May 04, 2022
From the archived source record
The claims on your website and social media accounts establish that your products, some of which are available in multiple varieties, “CBD Oil,” “CBD Capsules,” “Vegan CBD Gummies,” “CBD Pain Relief Cream,” “Delta 8 THC Gummies,” and “Delta 8 THC Vape Cartridge” (hereinafter referred to as “your CBD and Delta-8 THC products for humans”) are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). In addition, your “Natural Pet CBD Oil” is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and is adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). FDA has also determined that certain food products that you market are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Over the past several years, FDA has warned the public on various illegally marketed CBD-containing products. This letter is to inform you that your firm markets Delta-8 THC-containing products, and Delta-8 THC may pose a serious health risk to consumers. Unapproved New Human Drugs Based on a review of your website and social media accounts, your CBD and Delta-8 THC products for humans are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. High blood pressure is linked to higher risks of a number of health conditions, including stroke, heart attack, and metabolic syndrome.” April 14, 2020 post – “500mg: CBD & Menthol Pain Cream . . . bioMDplus 500mg CBD Pain Cream is a newly formulated pain relief topical cream made to soothe sore muscles and alleviate chronic joint pain.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 8b3b9c629711
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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