Evolved Ayurvedic Discoveries, Inc./BioCBDPlus

Warning LetterOpen

James Sol Radina Evolved Ayurvedic Discoveries, Inc./BioCBDPlus 315 S. Coast Highway 101 Suite U75 Encinitas , CA 92024 United States support@biocbdplus.com happy@eadlabs.comIssued Feb 11, 2021Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations2

Issue DateFeb 11, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Evolved Ayurvedic Discoveries, Inc./BioCBDPlus
Location: James Sol Radina Evolved Ayurvedic Discoveries, Inc./BioCBDPlus 315 S. Coast Highway 101 Suite U75 Encinitas , CA 92024 United States support@biocbdplus.com happy@eadlabs.com
FEI Number: N/A
Country: United States
Issue Date: February 11, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Evolved Ayurvedic Discoveries, Inc./BioCBDPlus was cited for marketing unapproved CBD drug products ("BioCBD+ Total Body Care," "BioCBD+ Topical Oil Muscle & Joint Support," and "BioCBD+ Peace Vape") in violation of sections 505(a) and 301(d) of the FD&C Act, as well as misbranding violations under section 502(f)(1). The company made disease claims on its website and social media platforms, including claims that the products could mitigate, prevent, treat, diagnose, or cure COVID-19, establishing them as unapproved new drugs. The inhalation product "BioCBD+ Peace Vape" was flagged as particularly concerning due to potential safety risks from ingredients and impurities that could trigger airway complications.

Evolved Ayurvedic Discoveries, Inc./BioCBDPlus FDA Warning Letter, February 11, 2021