Here's something you might be interested in.
Ask a Hipster — Advice you didn't know you needed
Big Screen — Movie commentary
Blurt — Music's inside track
Booze News — San Diego spirits
Classical Music — Immortal beauty
Classifieds — Free and easy
Cover Stories — Front-page features
Drinks All Around — Bartenders' drink recipes
Excerpts — Literary and spiritual excerpts
Feast! — Food & drink reviews
Feature Stories — Local news & stories
Fishing Report — What’s getting hooked from ship and shore
From the Archives — Spotlight on the past
Golden Dreams — Talk of the town
The Gonzo Report — Making the musical scene, or at least reporting from it
Letters — Our inbox
Movies@Home — Local movie buffs share favorites
Movie Reviews — Our critics' picks and pans
Musician Interviews — Up close with local artists
Neighborhood News from Stringers — Hyperlocal news
News Ticker — News & politics
Obermeyer — San Diego politics illustrated
Outdoors — Weekly changes in flora and fauna
Overheard in San Diego — Eavesdropping illustrated
Poetry — The old and the new
Reader Travel — Travel section built by travelers
Reading — The hunt for intellectuals
Roam-O-Rama — SoCal's best hiking/biking trails
San Diego Beer — Inside San Diego suds
SD on the QT — Almost factual news
Sheep and Goats — Places of worship
Special Issues — The best of
Street Style — San Diego streets have style
Surf Diego — Real stories from those braving the waves
Theater — On stage in San Diego this week
Tin Fork — Silver spoon alternative
Under the Radar — Matt Potter's undercover work
Unforgettable — Long-ago San Diego
Unreal Estate — San Diego's priciest pads
Your Week — Daily event picks
Pump and dump
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.
Here's something you might be interested in.
Pump and dump
Pump and dump
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.
Comments