Coral Rock Man, Inc. – FDA Warning Letter, Jun 1, 2012

On March 13, 2013, the FDA issued a Warning Letter to Coral Rock Man, Inc. DBA CRM Laboratories following an inspection from May 22 to June 1, 2012. The inspection revealed serious violations of the Federal Food, Drug and Cosmetic Act.

The firm's products, "X-ROCK All Natural for Men," "Z-ROCK All Natural," "X-ROCK All Natural 3 Day Pill For Men," and "X-ROCK for ERECTILE REFUNCTION The (3) Day Pill," were found to be unapproved new drugs and misbranded drugs. Laboratory analysis confirmed the presence of undeclared phosphodiesterase type-5 inhibitors (PDE-5 inhibitors) such as sildenafil, hydroxythiohomosildenafil, thiosildenafil, thiodimethyl sildenafil, and tadalafil. These ingredients are active components in FDA-approved prescription drugs like Viagra and Cialis, intended to treat erectile dysfunction.

The products are considered unapproved new drugs under sections 505(a) and 301(d) of the Act because they are not generally recognized as safe and effective. They are also misbranded under sections 502(f)(1), (2), and 502(a) due to failing to bear adequate directions for use, being false or misleading by not declaring the PDE-5 inhibitors, and lacking adequate warnings for potential serious health risks,