USA Labs AKA Power Source Distributors, Inc AKA USA Sport – FDA Warning Letter

The FDA issued a Warning Letter to USA Laboratories after reviewing their website, www.usalabs.com, in December 2017. The FDA determined that products sold on the website, including Maximum Male, Beta 300 (Beta Prosturol), Chromium Max 1000, DHEA, Healthy Cold-X, and Healthy Heart, are unapproved new drugs and misbranded.

The products are deemed drugs under section 201(g)(1)(B) of the Act due to claims on the website indicating their intent for use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims include "support help with erectile dysfunction" for Maximum Male, addressing "Prostatitis" and "Prostate cancer" for Beta 300, and "insulin regulator" for Chromium Max 1000. DHEA was marketed for heart disease prevention, Healthy Cold-X for destroying bacterial and viral invaders, and Healthy Heart for relieving congestive heart failure and other cardiovascular problems.

These products are considered "new drugs" under section 201(p)(1) of the Act because they are not generally recognized as safe and effective for their claimed uses. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, Maximum Male, Beta 300 (Beta Prosturol),