# FDA WARNING_LETTER - Pico IV Inc. - January 31, 2024

Source: https://www.keypedia.com/records/warning_letter/pico-iv-inc/27da7ff0-3356-4826-be39-6d815680571c

> FDA WARNING_LETTER for Pico IV Inc. on January 31, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Pico IV Inc.
- Inspection Date: 2024-01-31
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Joseph Young regarding "Pico IV," an intravenous cannabidiol (CBD) product offered on www.picoiv.com and promoted via social media (Facebook, Instagram). The FDA reviewed these sites in January 2024.

The "Pico IV" product is deemed an unapproved new drug, violating sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). The FDA highlighted public health concerns due to the injectable nature of the product, which bypasses the body's defenses.

The product is marketed as a dietary supplement, but the FDA states it does not meet the definition of "dietary supplement" under section 201(ff)(2)(A)(i) of the FD&C Act (21 U.S.C. 321(ff)(2)(A)(i)) because it is administered intravenously and not "intended for ingestion."

The FDA determined "Pico IV" is a drug under section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)) due to its intended use for disease diagnosis, cure, mitigation, treatment, prevention, or to affect body structure/function. Claims on social media

## Related Officers

- [Director](https://www.keypedia.com/people/tina-smith/5d590654-a270-4f3f-833f-d6fe13ca8c05)

Company: https://www.keypedia.com/companies/pico-iv-inc/5061c0e2-f5ef-4285-bb38-168d6d439fff

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