# FDA WARNING_LETTER - NeumaLife - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/neumalife/ba082965-03fc-4c79-94ca-58c722a3cda1

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: NeumaLife
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: The FDA issued a Warning Letter to NeumaLife regarding their product, Qina, marketed on www.neumalife.com. The FDA determined Qina is an unapproved new drug, not a dietary supplement, due to promotional claims indicating it prevents, treats, or cures diseases like cancer and HIV/AIDS, and affects body structure/function.

Specific violations include:
- **Unapproved New Drug:** Qina is promoted for treating conditions such as chronic illnesses, cancer, HIV/AIDS, tuberculosis, herpes, pneumonia, and asthma, and claims to reduce viral loads, increase CD4/CD8 counts, and improve quality of life. These claims classify it as a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). As it's not generally recognized as safe and effective, it's a new drug (section 201(p)) requiring FDA approval before interstate commerce (sections 301(d) and 505(a)).
- **Misbranding (Lack of Adequate Directions):** Qina's intended uses (e.g., HIV, cancer) are not amenable to self-diagnosis and treatment by laypersons, thus adequate directions for safe use cannot be provided, rendering it misbranded under section 502(f)(1).
- **Misbranding (False and Misleading Statements):** The website falsely claims Qina is "

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/john-w-thorsky/7a765cf2-aafc-48f7-98f5-172795a7d0d8)

Company: https://www.globalkeysolutions.net/companies/neumalife/d7b3b7d7-c6cc-4fce-836a-1ca5430187c2

Office: https://www.globalkeysolutions.net/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79