FDA WARNING_LETTER - ethos environmental inc - May 25, 2011

The FDA issued a Warning Letter to Ethos Environmental Inc. (d.b.a. Regeneca International, Inc.) regarding its product "Regenerect." FDA laboratory analyses found that multiple lots of "Regenerect," marketed as a dietary supplement, contained sulfoaildenafil, a PDE-5 inhibitor and analogue of sildenafil (the active ingredient in Viagra).

The FDA determined "Regenerect" is an unapproved new drug and a misbranded prescription drug. Its labeling claims, such as "erectile stimulant" and "Better Than Viagra," indicate drug intent, not dietary supplement structure/function claims. Sulfoaildenafil is a synthetic active pharmaceutical ingredient, not a nutrient or dietary ingredient. As a new drug, "Regenerect" lacks FDA approval for safety and effectiveness.

Furthermore, it is a prescription drug due to the potential for harmful effects from sulfoaildenafil, requiring professional supervision. The product is misbranded because it lacks adequate directions for use for a layman and fails to declare sulfoaildenafil, making its labeling false and misleading. This omission poses serious health risks, especially for consumers taking nitrates, as it can cause dangerous blood pressure drops. The product also lacks adequate warnings for users.

The introduction of this misbranded product into interstate commerce violates the Federal Food, Drug, and Cosmetic Act. Ethos Environmental Inc. must take prompt action to correct these violations within fifteen working days to avoid legal