# FDA WARNING_LETTER - Umbrella - May 18, 2021

Source: https://www.keypedia.com/records/warning_letter/umbrella/2c16d4a8-758a-4c49-93a3-a96d1ad984fa

> FDA WARNING_LETTER for Umbrella on May 18, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Umbrella
- Inspection Date: 2021-05-18
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA issued a Warning Letter to Umbrella Labs on May 18, 2021, following website reviews in November 2020 and February 2021, and product sampling. The letter identifies several products as unapproved new drugs and misbranded drugs, violating sections 505(a), 301(d), 502, and 301(a) of the FD&C Act.

Key violations include:
- **"Alpha Male Plus"**: Contains undeclared tadalafil (active ingredient in Cialis), making it an unapproved new drug and misbranded. It's excluded from dietary supplement definition due to tadalafil's prior drug approval and sublingual administration claims. Labeling lacks adequate directions for use and warnings regarding tadalafil.
- **Kratom Products ("Red Vein Bali Kratom Powder Mitragyna Speciosa," "Red Ketapang Kratom Powder Mitragyna Speciosa")**: Marketed with drug claims (e.g., anxiety, depression, pain relief, narcotic addiction withdrawal), rendering them unapproved new drugs and misbranded due to lack of adequate directions.
- **Nootropic Products ("Tianeptine Sodium Solution," "NACET Powder Nootropic")**: Marketed with drug claims (e.g., mood brightener, cognitive effects, COVID-19 mitigation). Tianeptine is not FDA

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)
- [Program Division Director](https://www.keypedia.com/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)

Company: https://www.keypedia.com/companies/umbrella/4066d772-3b63-40d3-916a-ff9de2c2fcd1

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6