# FDA WARNING_LETTER - BIOTA Biosciences LLC - April 23, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/biota-biosciences-llc/731651b3-f070-49e9-9faf-e268f3e28f15

> FDA WARNING_LETTER for BIOTA Biosciences LLC on April 23, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: BIOTA Biosciences LLC
- Inspection Date: 2020-04-23
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)

Company: https://www.globalkeysolutions.net/companies/biota-biosciences-llc/45e537df-1128-444e-96d8-c9ed97e1a3c4

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