Supplement Science Corp. d/b/a Condemned Labz – FDA Warning Letter, Sep 28, 2021

The FDA issued a Warning Letter to Condemned Labz after reviewing their websites in June, July, and September 2021, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The products Arsyn, ConvictStim, Humaslin, Thyrogenic, and DNA Dispatch are deemed unapproved new drugs and misbranded drugs because their website claims establish their intent for disease treatment, cure, mitigation, or prevention. Examples of claims include "Increases tolerance to pain" (DNA Dispatch), "Reduces blood sugar levels" (Humaslin), and "acts as a bronchodilator" (ConvictStim). These products are not generally recognized as safe and effective, making them "new drugs" requiring FDA approval, which they lack. They are also misbranded as they lack adequate directions for layperson use, being intended for conditions requiring professional supervision.

Furthermore, Arsyn and ConvictStim, labeled as dietary supplements, are considered adulterated. ConvictStim contains higenamine, a new dietary ingredient lacking the required safety notification and evidence of safety, with potential for cardiotoxic effects. Both Arsyn and ConvictStim contain 2-aminoisoheptane HCl, hordenine HCl, and higenamine HCl, which are deemed unsafe food additives because they do not qualify as dietary ingredients, are not GRAS (Generally Recognized As Safe), and lack premarket approval.

Condemned Labz must notify the FDA in