FDA WARNING_LETTER - Green Planet Inc - February 06, 2013

The FDA issued a Warning Letter to Green Planet, Inc. following a January-February 2013 inspection of its dietary supplement and beverage facility. The agency determined that two products, "Night Bullet Male Sexual Enhancer Capsules" and "Hemp Garden Tea," are unapproved new drugs and misbranded, violating sections 505(a), 502, and 301 of the FD&C Act.

"Night Bullet" was found to contain undeclared PDE-5 inhibitors (sulfohydroxyhomosildenafil, thiosildenafil, and aminotadalafil), analogues of active pharmaceutical ingredients in FDA-approved erectile dysfunction drugs. Despite being labeled as a dietary supplement, its intended use claims classify it as an unapproved new drug under 201(g)(1) and 201(p). It is also a prescription drug under 503(b)(1)(A) and misbranded under 502(f)(1) for lacking adequate directions, 502(a) for false/misleading labeling due to undeclared ingredients, and 502(f)(2) for lacking adequate warnings, posing serious health risks.

"Hemp Garden Tea" is marketed as a "street drug alternative" and is similarly classified as an unapproved new drug under 201(g)(1) and 201(p), lacking general recognition of safety and effectiveness.

Green Planet, Inc. must take prompt corrective action and respond to the FDA within fifteen working days, detailing steps to prevent recurrence. Non-compliance may lead to legal actions, including seizure, injunction, prosecution, and adverse impacts on future business operations and contract awards.