# FDA WARNING_LETTER - Bella Rose Labs - November 22, 2019

Source: https://www.keypedia.com/records/warning_letter/bella-rose-labs/18851c4c-5fc0-4d62-ab18-e1cc19e2e5e3

> FDA WARNING_LETTER for Bella Rose Labs on November 22, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Bella Rose Labs
- Inspection Date: 2019-11-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Ms. Castro regarding products sold on www.bellaroselab.com, including "BELLA ROSE HEMP OIL," "CBD HEMP FACIAL MOISTURIZER," "CBD ISOLATE," "CBD TOPICAL," "DISPOSABLE VAPE CARTIDGE CBD HEMP," and "YUMMY BEARS GUMMIES," all promoted as containing cannabidiol (CBD).

The FDA determined these products are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act, and misbranded drugs under section 502(f)(1) due to claims establishing drug intent (e.g., relief from inflammation, pain, anxiety, diabetes, cancer properties). As new drugs, they lack FDA approval for safety and effectiveness and adequate directions for layperson use.

Furthermore, "BELLA ROSE HEMP OIL" and "YUMMY BEARS GUMMIES" are mislabeled as dietary supplements, as CBD is excluded from the dietary supplement definition per sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, being an active ingredient in an approved drug (Epidiolex) and subject to substantial clinical investigations.

"YUMMY BEARS GUMMIES," if marketed as a conventional food, violates section 301(ll) because CBD, a substance

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Director](https://www.keypedia.com/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.keypedia.com/companies/bella-rose-labs/3c54c291-02e8-4abe-bb69-d223ea5dfbec

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