BIOTA Biosciences LLC – FDA Warning Letter, Apr 23, 2020

The FDA issued a Warning Letter to Ms. Romulus on April 9, 2020, following a February 2020 review of biotacbd.com. The FDA determined that the website offers injectable drug products, including "Canabidiol (CBD) Complex," "Cannabidiol+Curcumin," and "Curcumin Complex," which pose serious health risks due to direct bloodstream delivery.

These products are deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)) because website claims establish their intended use for disease diagnosis, cure, mitigation, treatment, or prevention, and/or to affect body structure/function. Examples of claims include "Fighting the opioid epidemic," "Instant relief for patients that are symptomatic of inflammatory auto-immune diseases," and "Bypass liver absorption completely making CBD immediately 100% bioavailable." The injectable form further supports their intended drug use.

Additionally, the products are misbranded under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) as their labeling lacks adequate directions for use, and the conditions they address are not amenable to self-diagnosis or treatment by laypersons. No FDA-approved applications