# FDA WARNING_LETTER - Aloha Medicinals Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/aloha-medicinals-inc/7fc75ecb-4e52-4f1b-a940-d7f69f64da61

> FDA WARNING_LETTER for Aloha Medicinals Inc. on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Aloha Medicinals Inc.
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: This FDA Warning Letter, dated April 6, 2010, addresses Aloha Medicinals, Inc.'s marketing of "Immune-Assist," "Levolar Forte," "Agaricus blazei Murill," "K-9 Immunity," "K9 Transfer Factor," and "Dog Immune." The FDA determined, based on website statements (www.alohamedicinals.com), that these products are unapproved new drugs and/or new animal drugs, and are misbranded.

Specifically, "Immune-Assist," "Levolar Forte," and "Agaricus blazei Murill" are deemed drugs under 21 U.S.C. § 321(g)(1)(B) due to intended use in human disease diagnosis, cure, mitigation, treatment, or prevention, and new drugs under 21 U.S.C. § 321(p) as they are not generally recognized as safe and effective for their labeled uses. Their introduction into interstate commerce without FDA-approved New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) violates 21 U.S.C. § 331(d).

"K-9 Immunity," "K9 Transfer Factor," and "Dog Immune" are classified as drugs under 21 U.S.C. § 321(g)(1)(B) for intended use in animal disease, and

## Related Officers

- [Director ](https://www.globalkeysolutions.net/people/barbara-j-cassens/26dd2da1-417d-4913-9432-3d50fb3c2f40)

Company: https://www.globalkeysolutions.net/companies/aloha-medicinals-inc/44531b6f-1dd3-41bb-aca1-1b30260c28a0

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df