FDA Issues Warning to ProLatis

DRAPER, UtahFDA issued a strong warning letter to ProLatis regarding the marketing and distribution of its ProLatis product. According to the agency, while the product is marketed as a dietary supplement, the agency holds it to be an unapproved new drug that is also misbranded under federal law.

The warning letter comes more than four months after ProLatis announced a voluntary recall of all lots of the product, after the company was informed that FDA testing found sulfoaildenafil, an analogue of sildenafil, in product samples. ProLatis conducted a national recall of all lots of the product manufactured prior to Aug. 9, as the active drug ingredient, which was not listed on the product label, could dangerously interact with nitrates found in some prescription drugs. However, in its recall notice, the company stated it had received no adverse event reports in connection with the products use.

FDAs Dec. 2 warning letter cites product claims including All-Natural Male Performance Pill" and Take 1-2 capsules 2 hours before sexual activity," which it claims are not structure/function claims but drug claims directly related to the activity of sulfoaildenafil in the product. Further, because FDA has not approved ProLatis as a drug, it is also in violation of federal law. Finally, FDA holds ProLatis to be a misbranded product as it lacks adequate directions for use as a drug product, and fails to include sulfoaildenafil on the product label.