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:
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
