innovative formulations, llc – FDA Warning Letter, Feb 22, 2024

The FDA issued a Warning Letter to Insane Labz on February 22, 2024, regarding their "WAKE THE DEAD SMELLING SALTS" drug product. The FDA reviewed the firm's website (insanelabz.com) on November 14, 2023, and Amazon storefront on February 14, 2024.

The product is cited as an unapproved new drug and a misbranded drug. It is considered a drug under sections 201(g)(1)(B) and 201(g)(1)(C) of the FD&C Act due to its intended use as a stimulant, affecting body function and intended for disease diagnosis, cure, mitigation, treatment, or prevention. Labeling claims indicate it releases ammonia gas, triggering a strong inhalation reflex, increasing heart rate, blood pressure, and brain activity, and is used for increased focus.

The product, containing ammonium chloride, is deemed an unapproved new drug under section 505(a) and 301(d) of the FD&C Act because it is not generally recognized as safe and effective (GRASE) for its intended use. Specifically, as a reflex stimulant, it falls under section 505G(a)(4) of the FD&C Act, subject to a 2008 proposed rule (73 FR 34895)