Gemini Body Works & the BBB  Gemini
Body Works is a salon based in Denver, Colorado. The owner,
Michael T. Ricks, Sr., sells treatments with the Super-Phaser
Gold, a transcutaneous patch hair removal system made by Rejuvenu
International Limited (formerly International
Hair Removal Systems).
Michael T. Ricks, Sr. claims this treatment can achieve permanent
hair removal. He probably also sells the devices to unsuspecting
people as a home business opportunity.
Gemini Marketing Enterprises and
treatment with the Super-Phaser Gold should be avoided by all
consumers. There is no published data showing these devices can
remove hair permanently.
Claiming that this device can achieve permanent hair removal
is a violation
of federal regulations.
I have also added a page addressing some of his personal
attacks against me.
Below is a complaint I filed with the Denver Better Business
Bureau and his response:
November 7, 2002
Attorney General
1525 Sherman St.
7th floor
Denver, CO 80203
VIA CERTIFIED MAIL
Re: Gemini Body Works, Aurora, Colorado
Dear Madam or Sir:
I am writing to notify you of a Colorado business promoting hair
removal devices and treatments that have not been cleared by the
U.S. Food and Drug Administration.
Practitioner: Michael T. Ricks, Sr.
Company: Gemini Body Works, LLC
Address: 11275 E. Mississippi Ave. Suite 1-E-1 Aurora, CO 80012
Phone: 720-857-8288
Website: http://www.truehairfacts.com/
Device: Super-Phaser Gold
Manufacturer: Rejuvenu (Southern Pines, NC)
These devices are sold as part of an MLM scheme. Dr. Ricks is
listed on the Rejuvenu website as a distributor, selling these
devices as a tiered affiliate. The devices are frequently sold
to unsuspecting consumers as a home-use device, a home business
opportunity, or an add-on service for salons.
At issue is the safety and efficacy of devices of this nature.
They are promoted as “permanent hair removal” despite
absence of any published data and any FDA clearance for any indication,
as noted in the enclosed FDA letter to the manufacturer dated
October 17, 2001:
“Absent FDA clearance, you have chosen to market this device,
and include claims that imply FDA clearance or approval. It appears
that you have made a decision independent of regulatory review
that your devices are equivalent to the cleared device.”
“There are no premarket notification clearances, for any
indication, for so-called hands-free transcutaneous, transdermal
cotton-tipped applicator probes, or continuous hair removal.”
In the enclosed promotional material from Gemini Body Works,
there is a photo of Dr. Ricks using both the cotton-tipped applicator
probes and the hands-free transcutaneous patches described as
violative by FDA Consumer Safety Officer Patricia Jahnes.
The Rejuvenu devices are often targeted to vulnerable consumer
groups who have difficulty using other methods of hair removal,
particularly African-Americans and low-income consumers hoping
to save money with alternatives to proven methods of permanent
hair removal. These devices are currently sold for about $10,000.00,
a very large cash outlay which then forces buyers to aggressively
market to unsuspecting consumers in order to recoup their up-front
costs.
Please consider taking action against Gemini Body Works to protect
Colorado consumers. Distributors like Dr. Ricks create several
levels of victims, including consumers misled by promises of permanent
hair removal and businesses who damage their reputations by selling
treatments with devices they were led to believe are cleared as
safe and effective.
Thank you for your consideration in this matter. Please contact
me if I can be of any further assistance.
Sincerely,
Andrea James
Hairfacts.com
Enclosures:
FDA letter to Rejuvenu regarding violations
Rejuvenu distributor list
Gemini Body Works promotional materials
Here's the response:
GEMINI BODY WORKS, LLC
“Your Alternative to Cosmetic Surgery & Laser Hair Removal”
P.O. Box 440371 Aurora, Colorado 80044-0731
Off: (&20) 309-3154
Fax: (303) 337-0721
Voice Pager: (888) 284-0526
Email: Geminibodyworks@aol.com
December 31, 2002
[stamped RECEIVED JAN 07 2003]
Denver/Boulder Better Business Bureau
Attn: Stephanie Kazmierski
1020 Cherokee Street
Denver, Colorado 80204-4039
RE: Andrea James- #62003100
Dear Ms. Kazmierski:
First, Andrea James continues to have no shame, attacking anyone
that is not using the same method for Permanent Hair removal as
the American Needle Electrology at every front with false accusations,
innuendos and other untrue “facts”. She is only supportive
of the antiquated and harmful needle methods and will not accept
any new technology. As a regular contributor to the American Needle
Electrology magazine and website, I have overwhelming reason to
believe that she is wholly financially supported by them.
Andrea James continues to misrepresent Rejuvenu and my involvement
with it. Lee Cole of Rejuvenu has been manufacturing permanent
hair removal devices since 1990, with research done 2 years before
that. He has been issued 3 US patents on the device and did get
FDA clearance in 1990 on the device. He has sold over 1000 units
in more than 50 countries, many to needle electrologists. He has
sold many units to doctors like dermatologists and plastic surgeons.
He has done several independent research studies, all of which
show permanent hair removal. Andrea James fails to mention any
of these facts in her letter.
The biggest misrepresentation in the complaint involves the distribution
method. Rejuvenu is the manufacturer of the device, selling both
wholesale and retail. The have never sold via MLM, pyramid schemes,
or any other non-traditional marketing methods. They sell to distributors
via agreements, which call for their purchase at a wholesale price
with minimum purchases and stocking requirements. The plan is
similar to thousands of other companies in the world that sell
through distribution channels. To compare Rejuvenu to MLM is an
attempt by Ms. James to imply that their business practices are
less than totally honest. Since she has no legitimate complaint
about Rejuvenu (except that their existence threatens her source
of livelihood) she can only resort to falsehoods.
There are many untruths mentioned in her complaint. I was interested
to note in the complaint. Ms. James impies that she has somehow
been damaged or injured by mt company and me. The fact is that
needle electrologists who are against any new technology because
they feel that it threatens their business support Ms. James.
Ms. James has never used the equipment or has ever been treated
by my company or myself. In fact, I cannot find any evidence that
she has ever been treated by anyone with any type of hair removal
equipment. Yet, she tries to pass herself off as an “expert”
in the field.
I initially purchased the device from Rejuvenu at the retail
price. I uised the device in my clinic, had excellent results,
and decided to become a distributor. As a distributor, I buy devices
atv a wholesale price and reseall at a retail price (the retail
price, unlike Ms. James states, is $8995, not $10,000). The poiunt
is, that I became a distributor only after I used the product
on my clients, cleared their hair, and wanted others in the business
to enjoy the opportunity to offer their clients a non-invasive
permanent hair removal method.
In her complaint, Ms. James is disturbed that I offer the service
to African Anmericans. The fact is, the Super-Phaser Gold method
is the only hope for many darker skin races to achieve permanent
hair remo9val. Since needle electrolysis is no usually used on
darker skin, she is upset. Since she is Caucasian, she cannot
understand the importance of this.
Finally, Rejuvenu do not sell devices for home use or home based
businesses. The Super-Phaser Gold is sold only to licensed professionals,
a fact stated in all oour marketing literature. As stated earlier,
many of these professionals are needle electrologists and physicians.
Dr. Mark Chandler, MD, for the past 14 years, have independently
researched many forms of hair removal equipment, including needle
electrolysis, laser and other light therapies, and the equipment
I operate, the Super-Phaser Gold. He has worked with the FDA on
many products, including the Super-Phaser Gold.
There is only a small excerpt of an FDA letter to Rejuvenu highlighted
in the complaint. This small section of a larger document seems
to imply that I am using and selling an illegal machine, one that
will harm people. Nothing could be further from the actual truth.
As stated in this FDA letter and many others, Lee Cole, through
his original company, American Hair Removal; obtained a 510(k)
clearance to market a non-invasive hair removal device. In the
research for the device, which Dr. Chandler supervised, proved
to the FDA that the device, which used tweezers and a specialized
gel, was equivalent to the needle (you will never hear this fact
from Andrea James). Claims of permanent hair removal were allowed
and have never been further questioned by the FDA.
At the time of the original clearance, this new method was classified
as a class II device. Later it was temporarily moved to Class
III, and then eventually to class I. What this reclassification
means is that the FDA is convinced that there is no concern with
safety of the device. As a class I device, there is no longer
even 510(k) clearance required.
When the company developed the probe and patch methods, they
determined, after extensiuve research, that there was essentially
no difference in safetry of effectiveness of the new applicatotrs
of the current. Indeed, they found that by increasing the time
the current flows and treating larger areas tielded as good, if
not better results. As the manufacturer of the product, the company
has the legislatively given right to determine whether any new
clearances are needed for any changes in the device. Simply changing
the applicator of the current, using the same current levels,
same gels, same pre and post treatment routines, does not require
a new 510(k).
The FDA, after bombardment from Andrea James and others in the
American Electrology Associations, wrote the latter quoted by
Ms. James. They asked for further evidence that the different
applicators do not require a new 510(k). Dr. Chandler and Rejuvenu
have sent them this evidence and await their response. While the
back and forth correspondence continues, Rejuvenu is totally and
completely in their right to sell and promote the product as they
have been doing. To state or imply that they are somehow breaking
the law is a gross falsification of the facts.
If the FDA eventually requires it, Rejuvenu will file a new 510(k)
to stay in compliance with the law. This will not change the fact
that the Super-Phaser Gold is cleared for permanent hair removal.
I am sure that Ms. James will continue to submit more dockets
against Rejuvenu to waste the FDA’s time. She has already
filed several dockets of more than 200 pages to the FDA over the
past 4 years, even going as far as accusing the FDA of making
mistakes in the original clearances. In their response, the FDA
has always vindicated themselves and Rejuvenu.
I hope this will help to answer the complaint by Ms. Andrea James.
Let me know if I can be of further help.
Regards,
[signed]
Michael T. Ricks, Sr., Ph.D.
President & CEO
“We provide cosmetic treatment services for”
Non-Surgical Facial Toning & Body Sculpting for Facelift,
Buttock Lift, Breast Enhancement & Cellulite Removal •
Permanent “No Needle” Hair Removal * French Peel Microdermabrasion
for removal of Acne Scars • Lines & Wrinkles • Age
Spots • Stretch Marks • Sun Damage • Scar Tuissue
• Massage Therapy • Herbal Body Wraps • Alexandria
Professional Body Sugaring-The Alternative to Waxing- for Facial,
Underarm, Bikini, LA (Brazilian), Arms, & Legs • Personal
Fitness Training • Nutritional Counseling & Dietary Supplements
• Massage Therapy • Body Wraps • Body Piercing
Member-The Society for Clinical and Medical Hair Removal, Inc.
(SCMHR)
Here's my response:
Dear Ms. Kazmierski:
Thank you for your letter of January 28, 2003 regarding my complaint
about the federally uncleared Super-Phaser Gold hair removal method
promoted by Gemini Body Works, LLC.
I have forwarded the response you received to FDA. As I am sure
you noted, owner Michael T. Ricks hopes that his rambling response
will distract from the fact that he sells violative devices and
treatments with them. He and the manufacturer have decided on
their own to circumvent regulators, which can lead to federal
charges. I’m sure FDA will find his statements and opinions
worthy of further investigation.
Rather than burden you with the hard copies of additional evidence
I would like to submit, I will refer you and any consumers defrauded
by unsubstantiated health claims regarding Rejuvenu and Gemini
Body Works to the following electronic copies of FDA dockets:
http://www.fda.gov/ohrms/dockets/dailys/052699/prc001.pdf
http://www.fda.gov/ohrms/dockets/dailys/01/Nov01/110501/01p_0505/prc0001.pdf
These are in PDF format and require the appropriate program to
read them.
A call to the U.S. Food and Drug Administration will quickly
dispel most of Mr. Ricks’ fabrications and corroborate the
letter I sent previously. As of this writing, FDA’s Office
of Compliance is being reorganized, and some personnel have been
shifted to different branches and Divisions. Their Promotion and
Advertising Policy Staff has been dissolved. Until all the dust
settles, you can refer questions regarding hair removal to:
Mr. Wally Pellerite
Special Assistant to the Director
Office of Compliance (HFZ-300)
2098 Gaither Road, Rockville, MD 20850
301.594.4692 Ext. 159.
Mr. Pellerite will then assign the case to George Kroehling who
is still branch Chief for General Surgery and is responsible for
these types of devices.
Other email contacts at FDA:
Patricia Jahnes (author of letter submitted in my original complaint):
PLJ@CDRH.FDA.GOV
George Kroehling (responsible for epilator regulation):
GZK@CDRH.FDA.GOV
If any Colorado consumers file a complaint regarding Michael
T. Ricks’ promotion of this hair removal device, please let
them know there are extensive resources available to help them
recoup the money they lost.
They can reach me at: andrea@hairfacts.com
I have helped consumers recoup thousands of dollars from people
selling treatments with this device, and I will happily assist
Colorado consumers however I can.
Thanks for your assistance in this matter.
Sincerely,
Andrea James
Hairfacts.com
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