# FDA WARNING_LETTER - Amerigo Labs LLC - November 13, 2017

Source: https://www.keypedia.com/records/warning_letter/amerigo-labs-llc/1006c1e0-cd1a-41f3-a698-b6ab6a25c06e

> FDA WARNING_LETTER for Amerigo Labs LLC on November 13, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Amerigo Labs LLC
- Inspection Date: 2017-11-13
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: On November 2-13, 2017, the FDA inspected Amerigo Laboratories LLC's dietary supplement facility. A March 2018 review of their website, poweruppowerdown.com, revealed that products PowerUp and PowerDown are marketed with claims establishing them as unapproved new drugs under 21 U.S.C. § 321(g)(1)(B), intended for disease cure, mitigation, treatment, or prevention. Examples include claims related to narcolepsy, ADHD, memory loss, chronic fatigue, and Alzheimer's.

These products are considered "new drugs" under 21 U.S.C. § 321(p) because they are not generally recognized as safe and effective for their intended uses, and thus require prior FDA approval. They are also misbranded under 21 U.S.C. § 352(f)(1) as they lack adequate directions for use by a layperson, being intended for conditions requiring professional supervision.

Furthermore, even if not classified as drugs, PowerUp and PowerDown are misbranded dietary supplements under 21 U.S.C. § 343 due to labeling deficiencies. These include failure to present nutrition information as per 21 CFR 101.36 and absence of a domestic address or phone number for adverse event reporting (21 U.S.C. § 3

## Related Officers

- [Division Director](https://www.keypedia.com/people/cheryl-a-bigham/10eee053-f062-4bcf-8e0f-2cd83f4928bf)

Company: https://www.keypedia.com/companies/amerigo-labs-llc/02cfb975-8840-4069-88a2-93b3648c6851

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