A California company has gotten itself in hot water with the FDA. You may not initially believe the rest of this, but it's reported by MedPage Today, one of the leading sources for "online health news sources, aggregators, and medical publishers" (1). It's real.
The FDA sent a warning letter to a California company called Dr. Joel Kaplan Inc. To say that the company is focused on the male apparatus (aka, trouser schnauzer) almost requires a new definition for the term "focused."
Get out now, while you still can
For those who may be easily offended by a multifactorial assemblage of sexually tasteless content, I suggest you immediately signal for the next off-ramp because this is gonna get nasty fast. Here's a snippet from the letter. Don't say you weren't warned. [my emphasis]
During an inspection of your firm, Dr. Joel Kaplan Inc... an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer and distributor of male and female sexual health enhancement medical devices such as the MegaVac Pump System, Metal Hand Pump System, STIMULATE: Red Light Therapy Wrap, DEEP: The Ultimate Penis Extender, and ...
the Clitoris Enhancement System.
Say what you want about these guys, but don't accuse them of bias! They manufacture industrial-grade genital adulteration contrivances for both genders, that is, assuming that we are permitted to use the archaic method of gender accounting.
Bernice (left) seems to be mildly intrigued about the "Clitoral Enhancement System" while James has a decidedly different reaction to the "MegaVac" penis pump. Free photo: Deposit photos
Naturally, I rushed to the Kaplan website to check out what other fine tools they might have in their arsenal. Check this out:
Paging Dr. Freud...
Specifics, anyone?
The right answer here is "no." If you haven't yet browsed over to the train wreck that used to be called Twitter this is your final warning. Because the following is the system the FDA wrote about.
The "MegaVac" penis pump, an "Ultimate" penis extender, and a "Clitoral Enhancement System," batteries not included. I cannot even begin to imagine what is in the bottle on the left when what looks like the assembly plant for a Boeing 777 is part of the total package. Image: MedPage Today.
What has the FDA so chafed?
When dietary supplements and medical devices run afoul of the law the problem is usually due to unproven medical claims. Ain't much of a shortage of those here.
FDA: Your firm sells the MegaVac Pump System. The product insert for the Mega Vac System states:
“Users report an increase in length and thickness . . or correction of mild penis curvature.” <----- medical claim
FDA: Your website includes the following statements about the STIMULATE: Red Light Therapy Wrap:
“I developed STIMULATE - a Red-Light Therapy Wrap to accelerate gains in thickness, length and erection rigidity <----- medical claim while using your favorite penis pump.” (As opposed to your second favorite penis pump?)
“STIMULATE embodies decades of research on Red-Light Therapy to maximize erection quality and size by boosting blood-flow, testosterone, and cellular repair <----- medical claim
(To be fair, although the company is making an unsubstantiated medical claim this doesn't mean that the product doesn't work. See Note #2.)
Saving the worst for last, women are invited to "pump" themselves as well.
FDA: Your Dr. Joel Kaplan (drjoelkaplan.com) website contains claims for the Clitoris Enhancement System:
- “INCREASED SENSITIVITY: Vacuum pressure stimulates the nerve-endings of the clitoris, making them more sensitive to touch and increases pleasurable sensations.”
- “HEIGHTENED AROUSAL: Increased blood-flow to the clitoral region triggers arousal and physical desire.”
- “Effectively increases clitoral sensitivity and sensation.”
- “Using vacuum pressure, the pump brings blood-flow into your clitoral region, increasing arousal and stimulation every time you pump. You will be more sensitive to touch and physical stimulation.”
- “Your sensitivity will increase because the pump increases blood-flow to the clitoris, stimulating your nerve endings in the region.”
- “You can use the pump before sex to heighten sensitivity so you and your partner will have an easier time bringing yourself to arousal and orgasm.”
Medical claims aside, Dr. Kaplan may be onto something here regarding clitoral stimulation, something I discussed previously in a 2023 J-Man Chronicles episode tastefully titled In Search Of The Elusive Snake Clitoris. A team of women led a study that discovered that snakes do indeed have a clitoris and that it's a damn good thing they did the research because men scientists had completely ignored this issue, in snakes and, by inference, in women too:
"The study also challenges a longstanding bias in biology — linked to cultural attitudes and a dearth of women in the field — that has left female sexual anatomy woefully understudied in [snakes]."
As if any man could find either.
Happy Valentine's Day to all. Just don't plug the pump into a 220V outlet.
NOTES:
(1) Source: OpenMD
(2) "A Men's Health writer tried a similar product and helpfully reported in 2019 that it worked. While he became 'significantly longer,' at least temporarily, his girlfriend wasn't enthusiastic." Translation: His bank account wasn't big enough.
Josh Bloom
Director of Chemical and Pharmaceutical Science
Dr. Josh Bloom, the Director of Chemical and Pharmaceutical Science, comes from the world of drug discovery, where he did research for more than 20 years. He holds a Ph.D. in chemistry.
