FDA to Dr. Kaplan: Erections, okay; enlargement, not okay.
San Diego’s economy has long been supportive of biotech, but a small portion of the industry may have just taken a big hit. It comes in the form of a warning letter sent last month by the federal Food and Drug Administration to Point Loma doctor Barry J. Kaplan, maker of something he calls the “MegaVac.” Kaplan’s device was originally approved for sale, the letter says, “to create and maintain penile erection in impotent men.” Instead the doctor has taken to “marketing the device for penis enlargement, length and correction of penile curvature, which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval.” According to the government’s allegations, Kaplan has been claiming that his customers can “gain 1–3 inches permanently” and “increase girth by 25%.” The doctor’s “deluxe hand pump,” his online ads say, can be used for “permanent increase in penis length, penis girth, and scrotal enlargement.” And those aren’t Kaplan’s only legal transgressions.
“FDA also determined that your firm manufactures the Clitoris Enhancement System. Clitoris Enhancement System devices are Class II devices and are regulated under 21 CFR 884.5970. A review of our records reveals that your firm has not received 510(k) clearance before offering this device for sale.” Besides those allegedly dubious gizmos, Kaplan’s website offers a variety of ostensibly virility-enhancing medicinals, including, notes the letter, “Original Penis Enlargement Pills (Vascular Dilator), Penis Enlargement Pills (Yohimbe Free), Tribulis Terrestris (Natural Viagra Alternative), and Male Booster (Natural Cialis Alternative).” Claims for the drugs, “promoted as ‘nutritional supplements’ alongside Dr. Joel Kaplan’s Official Pump Systems,” are “unsubstantiated,” the agency says. “Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.” A call placed to Kaplan at the MegaVac offices was not returned.