FDA WARNING_LETTER - Amerigo Labs LLC - November 13, 2017

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