FDA WARNING_LETTER - tager online, inc. - April 27, 2023

The FDA issued a Warning Letter to Ibrahim El Shahawy regarding the unapproved and misbranded drug "PrimeZEN Black 6000," sold via www.voltcandy.com, www.voltcandyonline.com, https://premierzen.com/, and www.facebook.com/voltcandy1/. An FDA lab analysis between December 2022 and March 2023 confirmed the product contains undeclared tadalafil and sildenafil, active ingredients in the prescription ED drugs Cialis and Viagra, respectively.

These undeclared PDE-5 inhibitors classify "PrimeZEN Black 6000" as an unapproved new drug under sections 505(a) and 301(d) of the FD&C Act, as tadalafil and sildenafil were not marketed as dietary supplements before their drug approvals. The product is also misbranded under section 502 of the FD&C Act, violating section 301(a), because its labeling lacks adequate directions for use, is false/misleading by not declaring the active ingredients, and lacks adequate warnings, posing serious health risks, especially for individuals on nitrates.

The letter notes previous FDA warnings about similar products sold by the firm, including "PremierZEN Gold 7000." The firm is responsible for investigating and correcting these violations and must submit a written response within fifteen working days detailing corrective actions and prevention measures,