January 14, 2020

Erica Williams
OIE Health and Medical Complaint Analyst
SC Dept. of Labor Licensing and Regulation
Office of Investigations and Enforcement
PO Box 11329
Columbia, SC 29211

Dear Ms. Williams:

This is me http://tinyurl.com/ych7o7dr

As a result of research by my wife and me into my father's bizarre career, I developed an interest in
experimental medical treatments/devices, medical ethics (including the use of human subjects in
unsupervised medical research), and oversight responsibility of public health authorities. The following
situation in your state appears to include all of those topics.

Via https://verify.llronline.com/LicLookup/Chiro/Chiro.aspx?div=38

Via https://www.drjosephcipriano.com/about-the-doctor

This is to request that your office review the following information and provide me with a determination if
Mr. Cipriano’s treatment of his patients using a device called the “Y-Strap decompression tool” is in
compliance with your agency’s guidelines.
I. BACKGROUND

Via YouTube chiropractors into huge viral stars; Videos of influencers getting their backs and necks
cracked are racking up millions of views on YouTube by James Nolan, WiredUK, October 15, 2019:

The Y-Strap is a black, mostly fabric harness that looks like something from an S&M dungeon. In
Joseph Cipriano’s YouTube videos, it's placed behind the necks of prone patients who, in the
moment before the crack, typically tense as if bracing for a crash.

Cipriano, a chiropractor based in Greenville, South Carolina, has become a YouTube sensation in
the past 18 months, taking his channel from inception last March to more than 850,000
subscribers.

Every video follows the same arc: a patient describes their malady to a chiropractor with a great
bedside manner, who then cracks them at different body points before the patient reveals they
feel much better. “I literally watched every video I could find on the Y-Strap first,” says Xavier, a
patient of Cipriano’s. “It’s pretty daunting to think you’re allowing someone to pull apart your
spine like a Lego.”

“Coowaa,” goes the sound as Cipriano yanks the Y-Strap and patient's skull away from their body:
a mix of them being dragged and cracks that ricochet down the spine, caused by bubbles forming
in the synovial fluid around joints. The noise is followed by either laughter, a grimace, or an
emotional release that can include crying. “I feel like I just grew two inches,” says one woman.

...Though chiropractors are not medical doctors, and the practice has been widely derided as
unscientific, Cipriano treats people with ailments such as back pain, scoliosis, fibromyalgia,
migraines, numb hands, and bad digestion, who are charged $200 (£158) a pop – or $100 if they
consent to filming.

...Daniel David Palmer, the Canadian who invented chiropractic in 1896, believed that the body
was self-healing, and that his treatments removed lesions that affected the nervous system, which
he called “subluxations”. Far from a cure for just back pain, he professed that chiropractic could
solve everything as subluxations caused 100 per cent of diseases.

...“Chiropractic spinal manipulation lacks plausibility,” says Edzard Ernst, a doctor and emeritus
professor of complementary medicine at the University of Exeter. “Contrary to what many
chiropractors are being taught and believe, they don’t correct subluxations for the simple reason
that such subluxations are a myth.”

...“The simple truth is that chiropractic manipulations fail to do more good than harm,” says
Ernst. “Watching videos of chiropractic might be amusing to some, but in reality, they send out a
wrong and dangerous message.”

Via 'Cracked Like a Glowstick': How Chiropractic YouTube Hooks Obsessive Fans; The tear-jerking,
spine-cracking videos are racking up millions of views, and sending more people to one of alternative
medicine’s most controversial practices by Hannah Smothers, Vice.com, December 12, 2019:

The woman lying face-up on the padded table looks like she’s about to be tortured. There’s a black
strap wrapped around the back of her neck. Two hands that belong to someone off-camera grip
the other end of it, winding up for a big yank like someone steadying to throw a dart. After a few
seconds, the hands pull the strap and the woman’s entire body jerks up off the table, led by her
head. There’s a loud crack and a moment that sounds like pain. Then, the thing that happens in
almost every video like this one: She raises her hands to her face, and starts crying.

...Over the past few years, chiropractors have carved out their own corner of YouTube—
something the platform has definitely noticed. Some, like (Joseph) Cipriano, are transparent
about YouTube being an incredible marketing opportunity; others say they simply love
showcasing their skills and spreading the word of chiropractic care. You can now watch just about
any type of person (or even animal) get cracked in any type of way. The videos range in levels of
gruesome: Cipriano’s Y-strap technique (the one that always makes people cry) is actually
 relatively tame; others, like the “Ring Dinger” videos posted by a guy in Houston, look like
consensual murder.

...“Nowadays, people are trying to seek out alternative ways to deal with pains they're having,”
Cipriano said. “People see these videos who never thought to try a chiropractor, and they’re
saying, ‘Oh my gosh, people are actually getting relief… from a chiropractor?!’ So many people
thought of our profession—I hate to say—as a joke.”

II. Mr. Cipriano & the “Y-Strap”

Please click through the following links which lead to videos posted on Mr. Cipriano’s YouTube site with
edited clips of him treating three different patients using the “Y-Strap.”

1) Source video (posted 6/25/19) https://www.youtube.com/watch?v=nxXGIkAVxmg

"Y-Strap" clip https://www.youtube.com/watch?v=3kk1K3LA7W8

2) Source video (posted 6/28/19) https://www.youtube.com/watch?v=jUpgJtHRFb8

"Y-strap" clip https://www.youtube.com/watch?v=NOVkYjdVn4g

3) Source video (posted 7/16/19) https://www.youtube.com/watch?v=QhgapYKDqy4

"Y-Strap" clip https://www.youtube.com/watch?v=f4HGu9RsbIY

According to this web page https://y-strap.com/product/y-strap and this Facebook page

https://www.facebook.com/pg/ystrapcom/about/?ref=page_internal the “Y-Strap” is manufactured and
sold by a company in Seville, Spain called Superior Balance SL.

Via https://y-strap.com/privacy-cookies-policy

The company’s website also features a video consisting of a compilation of clips showing the device in use,
apparently by chiropractors on patients.* A number of the clips feature Mr. Cipriano: https://y-
strap.com/product/y-strap/

The same web page includes this disclaimer:

Via the website of the U.S. Food & Drug Administration (FDA):
https://www.fda.gov/medical-devices/home-use-devices/fdas-role-regulating-medical-devices
FDA regulates the sale of medical device products (including diagnostic tests) in the U.S. and
monitors the safety of all regulated medical products.

In the U.S., FDA regulates the sale of medical device products. Before a medical device can be
legally sold in the U.S., the person or company that wants to sell the device must seek approval
from the FDA. To gain approval, they must present evidence that the device is reasonably safe and
effective for a particular use.

I searched https://y-strap.com and https://www.drjosephcipriano.com and the FDA’s database of

registered devices and failed to locate any information regarding whether the “Y-Strap” is registered with
that agency, so yesterday I phoned Superior Balance SL in Seville and a company representative informed
me that the device is not registered with the FDA.

When I asked if the device has been the subject of any published studies, the representative replied, “The
Y-Strap hasn’t been the subject of any clinical trials. Because there is no clinical proof that it works, we
don’t sell it as a medical product.”**

Therefore, Mr. Cipriano appears to be using his patients to test the medical benefits of the “Y-Strap.” In
your review, would you please determine which if any Institutional Review Board is overseeing his
research?

Thank you for your time/consideration and I look forward to receiving the results of your review.
Questions for me? Please don’t hesitate to ask.

Sincerely,

Peter M. Heimlich
REDACTED
Peachtree Corners, GA 30096
ph: (208)474-7283
e-mail: peter.heimlich@gmail.com
website: http://medfraud.info
blog: http://the-sidebar.com
Twitter: https://twitter.com/medfraud_pmh
bio: http://tinyurl.com/ych7o7dr

cc: Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health, U.S. Food and Drug
Administration

* According to an interactive map on this web page entitled, Where to find a Y-Strap Therapist, the device
is being used by chiropractors in a number of other states in the US: https://y-strap.com/where-to-find-
a-therapist-that-uses-the-y-strap-tool

** If you wish to obtain more information, I phoned (628)251-1063 (listed on Superior Balance SL's
website) which the rep told me connects to their Seville office. I was informed the company's president is
named Tom Lopez and that he may be contacted by e-mail at info@y-strap.com