Regenerect Warning Letter Made Public

Back in April we told you that FDA tests on the supposedly “natural” erectile dysfunction remedy had found some patently non-natural “spiking” going on. The agency claimed that it found a drug analogue of Viagra in the supplements and 2 lots of product was recalled. Now, the agency has made public a copy of its May 25th warning letter to the folks behind Regenerect, Ethos Environmental. Ethos Environmental also does business as Regeneca International.

The FDA accuses Ethos/Regeneca of selling “multiple lots” of the spiked Regenerect. It also accuses the company of violating current FDA regulations by hawking the stuff as a drug when, in fact, it’s labeled only for sale as a dietary supplement. And what’s especially interesting to us is that the agency seems to stop just short of accusing Ethos/Regeneca of knowing about the spiking all along.

So what has the FDA’s dander up? Well statements like these don’t help:

• “Better Than Viagra.”
• “Regenerect is an erectile stimulant that increases the size and duration of erections.”
• “Drug-free blend of natural, herbal ingredients that enhance and support sexual response.”

The truth is, says the FDA, those claims go well beyond what’s allowed for dietary supplements and, in fact, directly reference the spiking with the Viagra analogue. As the FDA puts it, “Rather, the structure/function claims are clearly made for the product as it relates to its sulfoaildenafil content.”

And not only does that make Regenerect a “new drug” as defined by the FDA; it makes it a prescription drug as well. That further violates FDA regulations because Regenerect is widely available through retail stores and the internet. (Regenerect is actually still for sale at Amazon.com as of this writing.)

The folks behind Regenerect were given 15 working days to address the FDA’s allegations or face further legal action—including possible seizure of any existing inventory. As of our visit to www.regenerect.com this morning we found claims like “Increases the size of your penis” and “Longer-lasting erections” still plainly visible on multiple pages.

Sources:

FDA. (2011). Ethos Environmental Inc dba Regeneca International Inc 5/25/11. (WARNING LETTER). Accessible at fda.gov/ICECI/EnforcementActions/WarningLetters/ucm256982.htm.

Regenerect. (2011). Multiple pages accessed from www.regenerect.com on May 31, 2011.