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#11503 - 07/12/02 07:55 AM Tend Skin warned by FDA
Andrea Offline
hairtell.com founder
Top 10 Contributor

Registered: 03/22/02
Posts: 4145
Loc: Los Angeles
On July 12, 2001, the Florida District Office of the FDA sent a letter to Tend Skin regarding health claims made in promotional literature.

FDA: Tend Skin warning letter

quote:
The drugs are also misbranded [Section 502(f’)(1 ) of the Act] because the labeling fails to bear adequate directions for use. The labeling is false and misleading as it suggests the products are safe and effective for their intended uses when, in fact, this has not been established [Section 502(a) of the Act].

The products are also misbranded because you have failed to register with the FDA as a drug manufacturer and have failed to list the drug products you manufacture [Section502(0) of the Act].

They were cited for many violations, although their claims for razor bumps and ingrown hair were not cited.

Consumers who are concerned about the safety of this product should consider other exfoliating options such as Bikini Zone and other over-the-counter products to resolve irritation from shaving and waxing.

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#11504 - 07/14/02 09:53 AM Re: Tend Skin warned by FDA
hopeful Offline
Member

Registered: 07/01/02
Posts: 31
yipe.
i was thinking of buying the stuff.

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#11505 - 07/14/02 10:06 AM Re: Tend Skin warned by FDA
Andrea Offline
hairtell.com founder
Top 10 Contributor

Registered: 03/22/02
Posts: 4145
Loc: Los Angeles
I still like and recommend this stuff, but those seeking alternatives:

Hairfacts: Topical shaving and waxing aftercare

Osys: No More Bumps website

Dermagen site

Aromashave website

Your local drugstore should also carry a few products like Bikini Zone and others.

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#11506 - 09/14/02 11:31 PM Re: Tend Skin warned by FDA
Andrea Offline
hairtell.com founder
Top 10 Contributor

Registered: 03/22/02
Posts: 4145
Loc: Los Angeles
I got the following letter from Steven Rosen, President of Tend Skin, on 14 September 2002. It's in response to a letter I sent in July about the FDA inspection and warning.

quote:

Hi Andrea,

I apologize for the extreme delay in getting back to you! You were told right that we had a visit from the FDA. We also had a few other agencies in here, all thanks to a former "friend" I've known for 20 years and who worked for me.

He tried to set me up for his own financial gain. Here is the FDA story.

They first visited us in Jan. 2001. They would not tell us how they got wind of us. Even a freedom of Information request did not help.

The crux of the 01/01 visit resulted in us having to improve the paperwork we maintained for our manufacturing, i.e. batch reports, label control, validation testing, etc.

The warning letter, which is public information stated that we were making "medical" claims for the topical use of aspirin, which is essentially what the product consists of. Claims we made included acne, cold sores, warts, fungal infections, insect bites, anti-itching, scar reduction, etc.

None of these claims are allowable in the drug monograph for aspirin. to make these claims one would need to go through a New Drug Application which costs a mint and takes several years. At that point, the product would be considered an OTC drug subject to extremely rigid manufacturing standards the agency calls cGMP's or Current Good Manufacturing Practices.

FDA came back again July 5, 2002, after notifying us of their impending inspection on July 3rd, and found everything ok.

Then unexpectedly, they returned on December 17th, 2001. We found out that the basis of the visit had to do with the Warning Letter from the Jan. 2001 visit...again, the medical claims!

What the investigator did not tell us, but what we later found out when FDA sent all companies they visited a copy of their complete inspection report. The reason for the December visit was "anonymous report #8779". The report was a complaint mentioning a bird being kept in the production area, falsified logbook entries for samples saved from batches, and people eating in the production area.

Well guess what? The investigator found none of these things. Unfortunately, she found that the claims to some extent were still on our web site and in our literature. Also, we got hammered on validation procedures not in place that we were never told we needed. We had to "voluntarily" dispose of all product in hosue because they said it was "tainted". We also had to "voluntarily" dispose of all our literature that still had the claims. FDA photographed the entire disposal process.

They also made us do a "voluntary" recall on the distributor level. That was a pain.

We should have only been down for a month in order to establish the procedures they requested. Unfortunately, we had to hire a consultant who knew how to implement the procedures. This "consultant" had his own agenda that wasted a month's time and a lot of $$$$. We eventually went back and just did what FDA demanded.

For the record, FDA never questioned safety or efficacy. We now market the produgt strictly as a cosmetic, and we have not heard from FDA since they visited in January solely to photograph the disposal of the product we had on hand.

The formula is essentially the same as before.

That's the gist of the story. Please let me know if you have any further questions and I will be happy to reply..in a much shorter period of time than this took!

Kindest regards,
Dr. Steven Rosen
Pres.
Tend Skin


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#69191 - 01/24/10 11:44 PM Re: Tend Skin warned by FDA [Re: Andrea]
ihavehair Offline
Major Contributor

Registered: 11/04/09
Posts: 123
Tend skin isn't good?
_________________________
Female considering electrolysis on most parts of body (face, arms, legs, back, stomach).

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#99286 - 06/08/12 05:08 AM Re: Tend Skin warned by FDA [Re: ihavehair]
Christina11ny Offline
Member

Registered: 09/24/11
Posts: 7
Loc: New York
I love tend skin but it is too strong for right after electrolysis. Since it has Salicylate acid it is great to help prevent ingrown hairs. They may have changed the strength since I first bought it. I prefer not to have clients use it every day and to wait at least 24 hours after the electrolysis treatment.

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#99296 - 06/08/12 02:09 PM Re: Tend Skin warned by FDA [Re: Christina11ny]
Michael Bono Offline

Top 10 Contributor

Registered: 01/11/11
Posts: 3051
Loc: Santa Barbara, CA USA
Even though the FDA is seriously under-funded, once they “get going” on anyone, it’s usually “curtains” for the company. I’m happy you survived.

It’s amazing to me that literally millions of products (making insane claims and not being regulated) are simply overlooked: many are brutally dangerous devices or products. And then those “medical studies?”

A couple doctors I know are “specialists” in writing reports on medical products for the FDA. You simply pay them the right amount (usually between $25 - $50,000) and you WILL get the correct data. Somehow 4 or 5 test patients become 25 - 30 and the report is always “glowing.” If the paperwork looks right, that’s about it!

The real and only test of a product is TIME! Sadly, all of us are involved in “product testing,” it’s just that we don’t know about it and that the “damage” won’t actually show up for many years.

You do know about dental X-rays and (benign) brain tumor? Sure, for decades they told us dental X-rays were “totally safe.” Not so Charlie (look it up). Of course, now they tell us that the “new” X-rays are much safer! Only took 40 -50 years to find this tumor link to X-ray!

I support the idea of testing and the FDA, but like most bureaucracies, they go “nuts” on anybody that happens to wander into their “gun sight.” And, somebody with an “ax to grind” can bring the whole officialdom down on you.

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