WASHINGTON—FDA has sent a warning letter to Ethos Environmental, an Irvine, Calif.-based direct response marketer operating as Regeneca, detailing numerous quality and labeling violations that render their Regenerect erectile dietary supplement a drug. The agency said laboratory analysis showed the product contained the erectile drug sildenafil and an analogue, while several labeling statements clearly fall under the realm of drug and treatment claims.
Among these statements are:
- “[A]n alternative to chemical erectile stimulants including products like Viagra*, Cialis*, Levitra* and other pharmaceutical drugs in the category.”
- “Regenerect is an erectile stimulant that increases the size and duration of erections.”
- “Natural Male Erectile Stimulant”
- “Drug-free blend of natural, herbal ingredients that enhance and support sexual response.”
- “Better Than Viagra”
The company was warned to take prompt action to correct the misbranded and illegal product, and was given 15 days to respond with details on these actions.
