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On Wed, 18 Nov 1998, Ken wrote:

> I just wanted to let everyone know what the FDA can do to providers of

alternative cancer treatments in this wonderful country of ours. I have

reoccuring breast cancer stage four. I chose to have surgery on a cancerous node

in my neck last Feb. send it to a lab in the Atlanta area that my Dr. knew

about. They made a vaccine out of the tumor and I inject that under the skin

along with an injection of Interlukin 2 and some kind of stimulating factor. I

went to Atlanta and they taught me how to do this it was no big deal. They send

me my meds after a blood test every mo. So I have one mo. with injections once a

week then I have a mo. off. That is the protocol. Now the FDA is saying the meds

can't be mailed to the patients that the patient's must make the trip to the

Atlanta area lab to recieve thier simple injections. This puts a real hardship

on the cancer patient who does not live in that area. For me it means driving to

Atlanta (6 hours) getting an injection I could easily give myself then turning

around and driving 6 hours home. I must make this trip now once a week for the

month of treatment. Of course I am willing and able to do this as I am not sick

at this point. What about those other patients who are ill and maybe live too

far away. What about the patients as far away as Canada who are on this

vaccine?? Probably they will have to stop taking this treatment. What is going

on here??? I think it is clear that the FDA is into harrassment of any Drs. or

researchers who are doing treatments that are not the usual chemo,radiation, or

surgery. To protest this I have written to a house of representative

congressman by the name of Dan Burton. His address is

> U. S. House of Representatives

> 2185 Rayburn House office Building

> Washington D. C. 20515

> FAX# 202 225-0016

> I am including this in hopes that you will all drop him a note about the

unfairness of this move on the part of the FDA. The name of the laboratory is

> Immunocomp laboratory,Inc.

> 320 Corporate Center Court

> Stockbridge, Ga. 30281

> The director there is Dr. McCoy. He is the reseacher who developed this

vaccine.

> Thanks for any of you out there that will take your time to help those of us

who are depending on this cancer treatment for thier very lives!!!!!!!!

> Judy Hoffman

>

>

> ------------------------------------------------------------------------

> Was the salesman clueless? Productopia has the answers.

> http://clickhere./click/1702

>

>

>

> Visit http://cures for cancer.evangelist.net for cancer info or to unsubscribe

>

> eGroups.com Home: cures for cancer/

> - Simplifying group communications

>

>

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  • 1 month later...

>From: ferret <ferret@...>

>

>

>I think the best place to find out about your name choice might be with

>the FDA itself. They have a toll-free number you can call during the week

>- 10 am or 11 am until 4 pm, I believe. It's listed on their Web site; I

>believe it's 1-800-INFO-FDA.

>

>- Ela

>

I agree with Ela on this one.

Tina

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  • 7 months later...

> From: <jen@n...>

> Date: Mon Aug 21, 2000 10:39pm

> Subject: FDA

> Can someone tell me where to look, or what the regulations are

> concerning packaging, labeling, preservatives, etc?

You can go to www.fda.gov. They have the entire Cosmetics Handbook

online.

- Ela

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Yikes!!

That is some scary stuff. I hope the FDA doesn't decide to tour my

" manufacturing facility " anytime soon! Gotta stow the four dogs, the

hairballs, and find a clean room quick! LOL

Thanks for the heads-up, Pat!

cindi

who may just stay small-time, cuz it seems so much easier

Pat McDonnell wrote:

> Hi All.

>

> I was looking at a disciplinary letter sent to Aubrey by the FDA the other

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I was looking at a disciplinary letter sent to Aubrey by the FDA the other

day and decided to browse some of the other letters. I came across one that

I believe pertains to most of us as it appears that this woman operated a

smaller business similar to what many of us operate. You can see the letter

at: http://www.fda.gov/foi/warning_letters/d1888b.pdf

I took a look at the letter mentioned above. This is quite scary stuff!

Would have been nice to see the labels of the products in question.

Maybe this is my ignorance showing but....it mentions a facial toner and it

sounds to me like just calling something a facial toner makes it a " drug " .

Also the soap mentioned...Almond Sage Scrub Hand Made Soap...the letter

states that it is labeled as an acne drug product. I can't tell that just

from the name. I'm guessing it was from other verbiage on the label...no?

Just curious,

Hope

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I agree its scary, but what can we do to protect ourselves?!

>

> Yikes!!

>

> That is some scary stuff. I hope the FDA doesn't decide to tour my

> " manufacturing facility " anytime soon! Gotta stow the four dogs, the

> hairballs, and find a clean room quick! LOL

>

>

> Thanks for the heads-up, Pat!

>

> cindi

> who may just stay small-time, cuz it seems so much easier

>

> Pat McDonnell wrote:

>

> > Hi All.

> >

> > I was looking at a disciplinary letter sent to Aubrey by the FDA the other

>

>

>

>

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Hi. Deby here. Yikes! is right. Makes me want to hide in a closet! And

cancel my order for jars. And stop making lotion (except it's better than

anything I ever bought! ). And consider my sanity for even thinking I could

do this. But there has to be a way, doesn't there? I mean, all I want to

do is share this wonderful stuff with people I know ( maybe a few I don't )

and make enough to keep going. Sigh..... where there's a will, there's a

way?

FDA

> Hi All.

>

> I was looking at a disciplinary letter sent to Aubrey by the FDA the other

> day and decided to browse some of the other letters. I came across one

that

> I believe pertains to most of us as it appears that this woman operated a

> smaller business similar to what many of us operate. You can see the

letter

> at: http://www.fda.gov/foi/warning_letters/d1888b.pdf You will need Adobe

> Acrobat to read it as it is in pdf format.

>

> Pat.

>

> Peace, Joy, Serenity

> House of Scents tm. Body Oils, Fragrance Oils, Incense, Candles, Soap,

Etc.

> achil@...

> http://houseofscents.safeshopper.com/

> www.yourhealthandbody.com

>

>

>

>

>

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Hi...how would the FDA know if you are making gifts for friends and

family?

richard saling wrote:

>

> Hi. Deby here. Yikes! is right. Makes me want to hide in a closet! And

> cancel my order for jars. And stop making lotion (except it's better than

> anything I ever bought! ). And consider my sanity for even thinking I could

> do this. But there has to be a way, doesn't there? I mean, all I want to

> do is share this wonderful stuff with people I know ( maybe a few I don't )

> and make enough to keep going. Sigh..... where there's a will, there's a

> way?

> FDA

>

> > Hi All.

> >

> > I was looking at a disciplinary letter sent to Aubrey by the FDA the other

> > day and decided to browse some of the other letters. I came across one

> that

> > I believe pertains to most of us as it appears that this woman operated a

> > smaller business similar to what many of us operate. You can see the

> letter

> > at: http://www.fda.gov/foi/warning_letters/d1888b.pdf You will need Adobe

> > Acrobat to read it as it is in pdf format.

> >

> > Pat.

> >

> > Peace, Joy, Serenity

> > House of Scents tm. Body Oils, Fragrance Oils, Incense, Candles, Soap,

> Etc.

> > achil@...

> > http://houseofscents.safeshopper.com/

> > www.yourhealthandbody.com

> >

> >

> >

> >

> >

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May I ask a favor?

I have a tiny little hard drive on a very old machine and can't read pdf

files. (No room for the reader). I was hoping to get a new machine

this spring, but it looks like I am instead getting braces for my

oldest....anyway. *g* Would someone mind sending me the text of this?

I would appreciate it.

Thanks.

richard saling wrote:

>

> Hi. Deby here. Yikes! is right. Makes me want to hide in a closet! And

> cancel my order for jars. And stop making lotion (except it's better than

> anything I ever bought! ). And consider my sanity for even thinking I could

> do this. But there has to be a way, doesn't there? I mean, all I want to

> do is share this wonderful stuff with people I know ( maybe a few I don't )

> and make enough to keep going. Sigh..... where there's a will, there's a

> way?

> FDA

>

> > Hi All.

> >

> > I was looking at a disciplinary letter sent to Aubrey by the FDA the other

> > day and decided to browse some of the other letters. I came across one

> that

> > I believe pertains to most of us as it appears that this woman operated a

> > smaller business similar to what many of us operate. You can see the

> letter

> > at: http://www.fda.gov/foi/warning_letters/d1888b.pdf You will need Adobe

> > Acrobat to read it as it is in pdf format.

> >

> > Pat.

> >

> > Peace, Joy, Serenity

> > House of Scents tm. Body Oils, Fragrance Oils, Incense, Candles, Soap,

> Etc.

> > achil@...

> > http://houseofscents.safeshopper.com/

> > www.yourhealthandbody.com

> >

> >

> >

> >

> >

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> That is some scary stuff. I hope the FDA doesn't decide to tour my

> " manufacturing facility " anytime soon! Gotta stow the four dogs, the

> hairballs, and find a clean room quick! LOL

That is funny Cindi, you are probably not alone though.

After submitting the FDA post I had many people contact me off list with

similar questions. I don't have the time to answer each individual post, so

I will try to cover it here on the list.

I have wrote on labeling laws several times on this list. Many people have

listened, but others think that I go a little overboard and have pooh poohed

me for it. Still others have said that the so-called natural companies that

mis-label must be right, based solely on their size. We can see from the

Wisconsin incident that this is not so, that the FDA does crack down on

people that mis-label and believe me, you don't want to be on the wrong side

of government. You could, be fined, you could be put out of business, or you

could end up in a very costly court case. I don't know about the rest of

you, but I can't afford any of those things to happen to me.

To the people who wrote to me though, I think most of you are over reacting.

Many of you were concerned about soap. The lady in WI was making drug

claims. It really doesn't matter to the FDA whether it was directly on her

labels, her brochures, web site, or even word of mouth, when it comes to a

drug claim, all of this would be considered part of her labeling. If you

list your ingredients properly, you can make all the cosmetic claims you

want and the FDA can't do anything about it. Cosmetics claims are mostly a

play on words. If you want to know how to do it, read the labels from the

giants in the industry, not the natural manufacturers. I don't know why

anyone who lists their ingredients would want to hide behind the soap

exemption, because behind the exemption, you can't make any claims.

The same advice goes for lotions and creams and any of your other products.

Make all the cosmetic claims that you want, but don't even hint at a drug

claim. It may be a good idea to have an expiration date, but I don't think

it is required on cosmetics, although I could be wrong. Testing is a good

idea, but not always practical for a small manufacturer, however, you should

keep a sample of each batch. You do need a good preservation system and in

order for it to work properly, you also need a good scale, preferably one

that will read to 1/10 gram. Under preserving is a bad idea and so is over

preserving. Without a good scale, you will end up doing one or the other,

and grams are a heck of a lot more accurate than parts of an ounce,

especially with small quantities.

Currently, I know of no natural preservative that will work with lotions and

creams. If there was one, the giant cosmetic companies would be using it

because they are well aware of how huge the market is for natural products.

If anyone thinks there is one out there, I would be real interested in

seeing independent lab testing to prove it. This is the other area that can

get you in deep doo doo where you could lose everything you own, and is not

worth taking a risk on. You won't be able to hide behind a corporate veil on

this one, I see officers of public companies getting sued all the time.

I didn't intend this to be so long, but I'm trying to answer list members

questions that either asked questions on or off list. Remember, label

properly, make all the cosmetic claims that you want. Don't ever, even hint

at a drug claim. We know what our products do and our customers know what

they do, it is unfortunate that we can't say it. Don't forget the FDA site

for the WI lady related solely to drug claims, had she used cosmetic claims,

she wouldn't have been in trouble.

Pat.

Peace, Joy, Serenity

House of Scents tm. Body Oils, Fragrance Oils, Incense, Candles, Soap, Etc.

achil@...

http://houseofscents.safeshopper.com/

www.yourhealthandbody.com

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Liz...

I do not know about anyone else's more complete Acrobat reader,

but my free acrobat reader does not allow copying of documents.

If there is a way, I wanna know it....

But it does allow printing of them.

So, if nothing else comes up, and especially if you live in reasonable snail

mail distance

(I am in Mass.) you might send me your snail mail address off-list, and I

could print and send.

Joanie

>May I ask a favor?

>I have a tiny little hard drive on a very old machine and can't read pdf

>files. (No room for the reader). I was hoping to get a new machine

>this spring, but it looks like I am instead getting braces for my

>oldest....anyway. *g* Would someone mind sending me the text of this?

>I would appreciate it.

>Thanks.

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Ever hear of Big Brother? Seriously, I guess they wouldn't know but like

Pat says, why take the chance. If I follow a few basic rules, guess I

should be fine, huh? Deby

FDA

> >

> > > Hi All.

> > >

> > > I was looking at a disciplinary letter sent to Aubrey by the FDA the

other

> > > day and decided to browse some of the other letters. I came across one

> > that

> > > I believe pertains to most of us as it appears that this woman

operated a

> > > smaller business similar to what many of us operate. You can see the

> > letter

> > > at: http://www.fda.gov/foi/warning_letters/d1888b.pdf You will need

Adobe

> > > Acrobat to read it as it is in pdf format.

> > >

> > > Pat.

> > >

> > > Peace, Joy, Serenity

> > > House of Scents tm. Body Oils, Fragrance Oils, Incense, Candles,

Soap,

> > Etc.

> > > achil@...

> > > http://houseofscents.safeshopper.com/

> > > www.yourhealthandbody.com

> > >

> > >

> > >

> > >

> > >

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I'm in the dark......what's the difference between cosmetic claim and drug

claim?? I didn't think you could make any claim.....

>

Many of you were concerned about soap. The lady in WI was making drug

>claims. It really doesn't matter to the FDA whether it was directly on her

>labels, her brochures, web site, or even word of mouth, when it comes to a

>drug claim, all of this would be considered part of her labeling. If you

>list your ingredients properly, you can make all the cosmetic claims you

>want and the FDA can't do anything about it. Cosmetics claims are mostly a

>play on words.

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  • 5 years later...

Interesting snippet from Reuters:

Long-term data not needed for depression drugs: panel

1 hour, 8 minutes ago

Drug manufacturers seeking U.S. approval

for drugs to treat major depression should not be required to first provide

data on how well they work long-term,

a Food and Drug Administration

advisory panel said unanimously on Tuesday. FDA officials are considering

changing the requirements for companies who

seek to market drugs for depression

and other psychiatric conditions. The agency usually follows the advice of its

advisory panels.

http://news./s/nm/20051025/hl_nm/long_term_data_not_needed_for_depression_dc;_ylt=Auy3Y6__IVzNY5XHdoD7nLQQ.3QA;_ylu=X3oDMTBiMW04NW9mBHNlYwMlJVRPUCUl

I guess we don’t need to bother studying

the long-term efficacy of anti-depressants for major depression.

We already know about their effectiveness

causing teenage suicides in the short term anyway!

I wonder whose palms are getting greased

on this one!

Glenn

Glenn F. Gumaer, B.S., D.C.

Chiropractic Physician

Northside Chiropractic Clinic

1240 N. Riverside Avenue

Medford, OR 97501-4619

541-770-1330 ofc

541-770-7090 fax

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  • 5 years later...

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