Sharon Spencer AHRS

Sharon Spencer, CEO of AHRS

Sharon Spencer lists herself as CEO of American Hair Removal Systems (AHRS) as of 2006. This is an electric tweezer scam that branched out into "transdermal electrolysis" with an electrified Q-Tip. An earlier version of this company was owned by Ruth Ellen Morris and is discussed on the original AHRS page.

American Hair Removal Sytstem should be avoided by all consumers.

Correspondence with Sharon Spencer

At her request, I am including all of our correspondence below on this page dedicated to her involvement with this company.

30 January 2006

Sharon Spencer:

I am the ceo of AHRS and would like to know where you are getting your information from about AHRS! I have read nothing so far that is factual. If you want the facts you need to consider asking the source… I suppect that you have reasons for telling these falsehoods and I am sure they are only in YOUR best interests…
Sharon
CEO AHRS

My reply that day:

Please list any "falsehoods" you believe exist in the hairfacts coverage of your product, and feel free to send along any information you feel will clarify who you are and what your company does. I am especially interested in your connection with Ruth Ellen Morris and and the late Lee Cole.

1 February

Sharon Spencer:

Thank you for the quick response. I will go back through your site and get my facts to you. As far as Ms Morris is concerned she no longer is the CEO of AHRS. Any questions you have for her, I would send them on to her and she can answer them for you. I do know this much for certain, you keep talking about Mr. Cole as though he has anything to do with AHRS. He has not been with AHRS for a very long time. I am not going to go into that at this particlar time, but there is documentation showing his departure from the company. As you know he is no longer around. I guess I would like to know exactly why you have it in for AHRS… As I say I will get my facts around and send them to you!

My reply that day:

I am a writer and consumer activist who specializes in putting scams out of business and helping consumers sue businesses making false marketing claims. As I mentioned, I have dealt with a lot of small business owners just like yourself over the years. Nearly all of them have abandoned this consumer category poorer but wiser.

Again, if you have any “falsehoods” you would like me to examine and correct if needed, please send them along.

2 February

Sharon Spencer:

Thank you for answering… the job must be very hard and time consuming. Do you write about other consumer frauds outside the field of hair? I will be notifying you again , at this time I am winding up the end of the year things. I sure you can relate.

My reply that day:

Yes, I am an affiliate of Quackwatch, and I cover other consumer issues, especially the intersection of cosmetic and medical procedures (surgery, dieting etc.). My main focus has been hair removal. Do you know who Michael Ricks is? He was the medical director for AHRS spinoff/rival Rejuvenu (also based in North Carolina). He is now doing a life sentence for (among other things) criminal fraud stemming from his transdermal electrolysis business. He used to have a site up about my work called truehairfacts.com, which was taken down after his arrest and subsequent conviction.

Sharon Spencer:

Andrea do you have any thing you could send me on Michael Ricks. I would be very interested in reading anything you night have or perhaps a web site that would tell about him.

My reply that day:

http://www.hairfacts.com/makers/etweezer/ihrs/michael-ricks-sr.html

3 February

Sharon Spencer:

Andrea, while looking the site you sent me I found this statement and I am wondering why you are opposed to this type of hair removal.And why you put on the web sites not to buy from AHRS. I also called Ms Morris and asked her about Micheal Ricks. She has never heard of him. And that he was never apart of the TE System. She did say that AHRS and Rejuvenu are totally different companies. The only thing they have incommon is the fact that Lee Cole was once affiliated with AHRS,, A law suit developed to take control of the company because he was a frauduent crook. AHRS was awarded to Ms. Morris. Can you help separate the two companies. I thinnk there has been a misunderstanding about the whole thing. These type of things are why I consider things that are said on your site as being falsehoods. I have not seen where you have said the the 629 has been approved for tweezer electrolysis. I think consumers should be aware of the products they buy but on the other hand if a product has been found to be legitiment then why not let them go about their business and let them get a clear representation of the product

If there is something else that is wrong with this product, please inform me and I will see what I can do to rectify the problem.

As a business owner and consumer this type of thing needs to be settled so that everyone is comfortable with the results.

My reply that day:

The AHRS Epilator 629 was cleared under K892514 as a galvanic tweezer-type epilator, along with claims for permanent hair removal. Since our April 2 letter was sent, we further reviewed and discussed the permanent hair removal claim with our Office of Device Evaluation (ODE). We agree that the permanent hair removal claims for this device were in accordance with a definition that was commonly used in the context of hair removal at the time that the clearance was granted. Therefore, claims for permanent hair removal are allowable for this device, but these claims are limited to the tweezer epilator mode.Let me give you a history lesson on the sordid history of your new business associates. Lee Cole is the person who got the FDA clearance for AHRS you keep mentioning. Lee Cole got the AHRS patents. Lee Cole lost the business in some sort of apparent custody battle or something.

In 1989, electric tweezer manufacturer American Hair Removal Systems (AHRS) submitted FDA Docket  K892514 to the U.S. Food and Drug Administration for an electric tweezer called the TE 629. This device used galvanic current and made claims of permanent hair removal.

Following several failed submissions rejected by FDA reviewer Theodore Stevens, AHRS submitted an unpublished in-house report on 5 subjects followed for 9 weeks. On August 8, 1990, the new FDA reviewer, Paul Tilton, allowed 9 weeks as a performance standard for permanent hair removal. Subsequently, AHRS (and a clone called GHR, which Tilton cleared in 1991) could claim they’re "permanent."

Since that time, FDA no longer considers 9 weeks an acceptable standard for permanent hair removal, but they have been unwilling to rescind clearance for these two electric tweezers. In 1998, FDA published a Final Rule reclassifying electric tweezers, stating:

    "FDA acknowledges that the published literature contains no evidence of statistically significant data showing that the device is effective in achieving permanent removal of hair.

    Additionally, FDA acknowledges that there is no statistically significant scientific data available at this time to support promotional claims of permanent or long-term removal of hair through use of the device."

While this was welcome news for consumers, FDA stated that despite a lack of statistically significant data and no published clinical evidence of permanence, they were going to allow AHRS and GHR to continue to claim they were permanent.

I couldn’t believe this, so in 1999, I filed a petition with FDA to reconsider this decision.

For an extensive critical analysis of the Tilton decision, as well as the original AHRS submissions and FDA correspondence, you can download my petition as Docket 99P-1614.

Below is the response I received from FDA regarding this petition. Highlights are in bold.

Essentially, their argument is that the performance standard submitted by AHRS was "commonly used in the context of hair removal at that time." This performance standard is in fact a promotional brochure that was put out by an electrolysis trade group called the International Guild of Professional Electrologists (IGPE). This IGPE standard was not scientifically sound and was not commonly used at the time, and in fact had been condemned by the largest electrolysis trade group. This standard has since been rescinded by IGPE, although the original author continues to use the same sales brochure almost verbatim to promote his own electrolysis practice.

The Tilton decision is an unfortunate footnote in the history of hair-removal regulation and a triumph of quackery over good science. Both the AHRS submission and the IGPE "standard" do not pass scientific scrutiny and would never have made it past a competent FDA reviewer.

In January 2000, FDA responded to my request for clarification as follows:

First, you request that we rescind the device clearances as substantially equivalent to predicate needle-type epilators. The initial classification of the AHRS Epilator 629, as a needle-type epilator, was made in error. We corrected this mistake shortly after we determined the device to be substantially equivalent to a preamendment tweezer-type epilator. We accomplished the correction by issuing a revised order to the manufacturer that reflects the proper classification of the device. Concerning the GHR System, our records show that the device was not cleared for marketing as a needle-type epilator, but was also cleared as a tweezer-type epilator. Therefore, your request is based on an erroneous assumption that these devices have been found substantially equivalent to needle-type epilators.

The words "permanent" or "long-term" are not part of the definition in the classification of tweezer-type epilators. The supplementary information section of the final rule, however, states that there is no statistically significant data available to support promotional claims of permanent or long-term removal of hair through use of the tweezer-type epilator. This statement was included in the preamble because there was insufficient information submitted in support of the reclassification to establish "permanent" or "long term" removal and because there is no universally accepted definition for these words when used in the context of hair removal.

While claims for permanent and long-term hair removal appeared in 510(k)s K892514 and K905125, these words were used in accordance with a definition that was commonly used in the context of hair removal at the time that the clearances were granted. Although a debate over the proper use of these words in the context of hair removal has ensued, FDA does not believe that there is sufficient justification to change the regulatory status of these devices, or to take immediate regulatory action against manufacturers using the words "permanent" or "long-term" in their promotion and advertising materials.

I hope this clarifies this for you. These devices have not been proven to work as claimed, despite being available for decades. If a cheap and painless permanent hair removal option like this really worked, market forces would have made this the industry standard years ago.

As I said, I have had this exact same discussion with many people just like you over the years. I recommend talking to some of the people who have been using Morris’ device in their salons since 1990 and see what they have to say. Good luck finding one. You are involved in a long-running ploy that targets uneducated salon owners and people hoping to start a home business.

As described here:

http://www.americanhairremovalsystem.com/product2.htm

The “surface probe” you sell is not cleared by FDA, and if you’d like me to report you for selling adulterated and misbranded devices as I did with Rejuvenu, I’d be more than happy to do so. You won’t go to jail, but you will get a federal inspector visit and possibly fines and a warning letter. Patents mean nothing in terms of efficacy. There are patents for all kinds of things that do not work.

I am trying to save you a lot of long-term problems, but if you insist on moving forward, I am more than happy to  bring you to the attention of federal regulators and get you shut down.

8 February

Sharon Spencer:

I believe we are going around in circles. I do not claim that the TE System is permanent. That went out with the word painless. You asked me to prove to you the parts of your statements that were untrue. I did so. As far as I am concerned you are not willing to accept what I have told and showed you. I have merely stated that AHRS is not or has never been affiliated with the other companies.. Yes, Lee Cole might have been the one submitting the patents and contacted the FDA, however he was not connected with AHRS when all the other companies sprung up. AHRS is a reputable Corporation and I don’t appreciate being affiliated with any other companies in you writings.

I have talk with the FDA for the last few days because I wanted to make sure that this product was sale able… they assured me that it was not only sale able but I could even sell it on ebay! I want my consumers to have training so they know what they can expect and what is reasonable for the treatments. We know that hair removal is a process not a one time cure. Ebay for AHRS is totally out of the question.
You might look up some of the other sites and see what they have to say.
http://www.nevershaveagain.com
http://www.global-electrolysis-supply.com
http://www.folica.com*
http://www.rejuvenu.com/*

Since I have talked with the FDA I am just going to go about my business. I am not sure if you have ever had this process done or even in the needle form. You are wrong when you say that no one uses them anymore. There are many that do. From Hospitals, spas, drs. offices and yes cosmetologists. Some my have put them in the closet and forgot about them, but if so they weren’t serious enough to get the training that was offered when they bought the System. AHRS can sell the system to who ever wants to buy one, however AHRS cannot make them take the training. AHRS does not use guns, thugs, knives and any other type of persuasion to sell this product. It is up to the consumer to research their need for the service and it is their responsibility to get the training they need to use it correctly.

I personally have treated people and have had wonderful success. And believe it or not it does turn out to be permanent! I guess they were just lucky huh?. Even the needle process takes months and even years to remove the hair. The biggest complaint that I have heard and seen is the scarring and the nerve damage from the needle.

As far as the probe, the TE 629 uses this for the skin anylizing part of the System. It measures the amount of sebum on the skin.

I am sure you will not be posting this in the HAIR FACTS because you like to say what you want and not let the consumer hear the other side of the story.

My reply that day:

I am happy to put up all of our correspondence on a permanent page dedicated to your involvement with the device. Let me know if that’s OK.

Sharon Spencer:

That would be fine with me Andrea and thank you for your time.

Although this device has been cleared by FDA, there is considerable controversy surrounding the effectiveness of the device. For details, see my electric tweezer petition to FDA.

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>