Victoria Morton: Suddenly slender with Pseudomonas aeruginosa
Tilman Hausherr
Victoria Morton seems to be pseudomonas aeruginosa
http://www.pseudomonas.com, really nasty bacteria:
http://www.fda.gov/foi/warning_letters/g4788d.htm
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Rockville, MD 20857
CERTIFIED MAIL
RETURN RECEIPT REQUEST
WARNING LETTER
FLA-04-21
March 5, 2004
Ms. Victoria M. Morton
President & Owner
VMM Enterprises, Inc.
172 N. Belcher Road
Clearwater, FL 33765
Dear Ms. Morton:
Inspections conducted by the Food and Drug Administration (FDA) on
October 2001, April 2002, and August 2003, revealed serious violations
of the Federal Food, Drug, and Cosmetic Act (the Act). Since the
issuance of the FDA 483, Inspectional Observations form, at the 2001
inspection, your firm has failed to address the adulteration issues for
your products and continues to operate with almost no adherence to
current Good Manufacturing Practice (cGMP) regulations. Analysis of
samples collected during the August 2003 inspection shows high
microbial, yeast. and mold counts.
While you contend that your firm’s body concentrates and powder products
are cosmetics or dietary supplements, FDA has determined that they are
drugs as defined in section 201(g) of the Act. This conclusion is based
on your firm’s claims about the products concerning their intended
effect on the structure or function of the body (structure/ function
claims). Structure/ function claims are not permitted for cosmetics.
Further, these products cannot be dietary supplements because they are
not ingested or used to supplement the diet. Rather, the labeling for
these products states they are for body tightening and slimming
applications. The drug products that your firm manufactures and
distributes, which include, but are not limited to, Gold Water
Concentrate Solution, Power Wrap Concentrate Solution, Anti-Aging Wrap
Concentrate
Solution, Lipase Concentrate Solution, Slender Tone Solution Powder, and
MSM Slender Tone Solution Powder are in violation of the Federal Food,
Drug, and Cosmetic Act, as follows:
Section 502(i)
A drug shall be deemed to be misbranded within the meaning of section
502(j) if it is dangerous to health when used in the dosage or manner;
or with the frequency or duration prescribed, recommended, or suggested
in the labeling thereof. Specifically:
Your raw materials and finished products were analyzed and found to be
contaminated with Pseudomonas aeruginosa in an earlier inspection. In
addition, the analysis of samples collected during the August 2003
inspection shows high counts of microorganisms, yeast, and mold (>105
cfu/g).
Citricidal and Today’s Healthy Solution Liquid Silver are used by your
firm as preservatives. Neither of these ingredients is acceptable as a
preservative or adequate to control microbial growth. You did not
conduct studies or provide data to demonstrate that these ingredients
function as preservatives or have antimicrobial properties.
Your firm’s technical bulletins and training sessions instruct your
salon licensees to indefinitely retain and store the Body Wrap solutions
in a manner (i.e. maintain warm temperatures and reuse the product) that
could increase the likelihood of bacterial proliferation in the
products.
A number of salon customers, who had the body wrap treatment,
experienced skin rash injuries. State health departments have several
reports of customer injuries and some rashes have been diagnosed as
caused by Pseudomonas aeruginosa.
Section 501(a)(2)(B)
Your products are adulterated within the meaning of section 501(a)(2)(B)
of the Act in that the controls and procedures used in their
manufacturing, processing, packing, and holding of drugs do not conform
to current Good Manufacturing Practice regulations, Title 21, Code of
Federal Regulations, parts 210 and 211. Deviations from these
regulations include, but are not limited to, the following:
1. Failure to establish procedures designed to prevent objectionable
microorganisms in drug products not required to be sterile (21 CFR
211.113(a)).
Specifically, there are no procedures to prevent objectionable
microorganisms. In fact, there have been two outbreaks of adverse
reactions (rashes) reported in September 2001 and March 2002 by body
wrap clients. The drug products were contaminated with Pseudomonas
aeruginosa.
2. Failure to establish and perform appropriate laboratory testing on
the drug products required to be free of objectionable microorganisms
(21 CFR 211.165(b)).
3. Failure to establish responsibilities and procedures applicable to
the quality control unit (21 CFR 211.22(a)).
4. Failure to establish an adequate control system for incoming
components, materials, and container/enclosures
(21 CFR 211.84).
For example, there are no procedures for receipt and storage of
components and there is no adequate documentation of the testing and
approval or rejection of components, drug product containers, and
closures.
5. Failure in laboratory controls to establish scientifically sound and
appropriate specifications, standards, sampling plans, and test
procedures designed to assure that the components, drug product
containers, closures, in-process materials, labeling, and drug products
conform to appropriate standards of identity, strength, quality, and
purity (21 CFR 211.160(b)).
For example, acceptance and release specifications have not been
established for components, drug product containers, closures, and
finished drug products. Finished drug products also include products
manufactured under contract by [redacted]
6. Failure to perform finished product testing prior to distribution (21
CFR 211.165(a)).
7. Failure to establish written procedures for production and process
control of the drug products in order to assure that the drug products
have the identity, strength, quality, and purity they purport to possess
(21 CFR 211.100(a)).
8. Failure to establish complete batch production and control records
for each batch of drug product (21 CFR 211.188 (b)).
For example, the batch records do not document that each significant
step in the manufacture of the batch was performed. In addition, batch
production and control records were missing for lots LW8020625 and
PW8020731.
9. Failure to establish complete master production and control records
to ensure drug product uniformity from batch to batch (21 CFR 211.186).
For example, the master production and control records lack an accurate
statement of the weight or measure of each component used in making body
wrap powders.
10. Failure to establish procedures and keep records of cleaning and
maintenance of manufacturing equipment (21 CFR 211.67(b) and (c)).
11. Failure to routinely calibrate, inspect, or check automatic,
mechanical, and electronic equipment according to a written program
designed to assure proper performance (21 CFR 211.68(a)).
12. Failure to provide training to employees in current good
manufacturing practice as required by the employee’s function (21 CFR
211.25(a)).
13. Failure to establish a stability testing program to assess the
stability characteristics of the drug products (21 CFR 211.166(a)).
Specifically, there is no stability data on which to base the expiry or
shelf life of any of the drug products.
14. Failure to establish procedures by which the distribution of each
lot of drug product can be readily determined to facilitate its recall
if necessary (21 CFR 211.150(b)).
15. Failure to establish written procedures describing the handling of
all written and oral complaints regarding a
drug product (21 CFR 211.198 (a)).
16. Failure to maintain a written record of each complaint in a file
designated for drug product complaints (21 CFR
211.198(b)).
Specifically, there is at least one complaint regarding an alleged
reaction to a body wrap treatment for which no record was made and an
investigation was not conducted.
We acknowledge receipt of your written response to FDA dated April 12,
2002, June 10, 2002, and July 31, 2003. Your response is inadequate
because you did not address any of the CGMP violations or offer any
corrective actions to these deviations. Overall, your firm does not
demonstrate that your manufacturing process is in a state of control.
The above violations are not intended to be an all-inclusive list of
deficiencies at your facility. It is your responsibility to assure that
all drug products manufactured and processed at VMM Enterprises, Inc.
are in compliance with federal laws and regulations. Failure to promptly
correct these violations and prevent future violations may result in
regulatory action, such as seizure and /or injunction, without further
notice.
Please notify this office within 15 working days of receipt of this
letter of the specific steps you have taken to correct these violations,
including an explanation of each step being taken to prevent the
recurrence of the violations.
Your reply should be directed to the Food and Drug Administration at the
address shown below:
Florida District Office
555 Winderley Place, Suite 200
Maitland, FL 32751
If you have questions or concerns regarding this letter, please contact
Shari H. Shambaugh, Compliance Officer,
at 407-475-4730.
Sincerely,
/s/
Emma Singleton
Director, Florida District Office
http://www.fda.gov/bbs/topics/enforce/2002/ENF00726.html
PRODUCT
Anti-Aging Wrap solution, 8 oz., 32 oz. and 36 oz. plastic bottles.
(conditioned water plus a proprietary blend of sodium magnesium and
potassium salts, boron and other naturally occurring trace elements and
herbal essences), Recall # D-070-2.
CODE
All Codes labeled as "Anti-Aging Wrap" that were
distributed from 10/1/00 through 10/1/01 including
lot #'s AA439090500 and AA110101CS.
RECALLING FIRM/MANUFACTURER
Recalling Firm: VMM Enterprises, Inc. Clearwater, FL , by letter on
Oct. 8,
2001.
Manufacturer: Pyramid Consulting and Investiment Co., Inc. Clearwater,
FL.
FDA initiated recall is ongoing.
REASON
Microbial Contamination; product is contaminated with
Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
Android Cat
> The "secret" of "suddenly slender body wrap" of scientologist
> Victoria Morton seems to be pseudomonas aeruginosa
> http://www.pseudomonas.com, really nasty bacteria:
>
> http://www.fda.gov/foi/warning_letters/g4788d.htm
> Department of Health and Human Services
> Public Health Service
> Food and Drug Administration
That might explain why the web sites of Suddenly Slender franchises have
been gradually closing.
--
Ron of that ilk.
Android Cat
> The "secret" of "suddenly slender body wrap" of scientologist
> Victoria Morton seems to be pseudomonas aeruginosa
> http://www.pseudomonas.com, really nasty bacteria:
>
> http://www.fda.gov/foi/warning_letters/g4788d.htm
> Department of Health and Human Services
> Public Health Service
> Food and Drug Administration
My list of Suddenly Slender franchise web sites. (A few are already toast.)
www.beslendernow.com
www.bodywrapdallas.com
www.bodywrapsandbeyond.com
www.changeyourshape.com
www.charismaslenderspa.com
www.healthyimage.biz
www.houstonbodywrap.com
www.imagemakerssalon.com
www.inchawaybodywrap.com
www.itsawrapbodysalon.com
www.levisagesalon.com
www.lookngood.net
www.naturalhealingpath.com
www.olympianbody.com
www.placetorelax.com
www.salonunlimiteddayspa.com
www.shapelymeasures.com
www.slenderella.com
www.slenderhour.com
www.slender-solutions.com
www.slimwrap.com
www.spalife.us
www.suddenlyslender.com
www.suddenlyslendersalon.com
www.suddenlyslenderyou.com
www.suddenlyslimmer.biz
www.suddenlyslimmerofca.com
www.tampa.wrapshop.com
www.thatsawrapofbrentwood.com
www.totalbodydayspa.com
www.totalwrapture.com
www.wrapyourbody.com
I really wonder how much they try to steer clients onwards to stuff like the
Purif.
Android Cat
> Tilman Hausherr wrote:
>> The "secret" of "suddenly slender body wrap" of scientologist
>> Victoria Morton seems to be pseudomonas aeruginosa
>> http://www.pseudomonas.com, really nasty bacteria:
>>
>> http://www.fda.gov/foi/warning_letters/g4788d.htm
>> Department of Health and Human Services
>> Public Health Service
>> Food and Drug Administration
>
> My list of Suddenly Slender franchise web sites.
Updated. In spite of a lot of dead sites, there seem to be a whole bunch
more franchises.
reading.wrapshop.com Wrapture :: Featuring Body Wraps and airbrush tanning
services in Reading & Sinking Spring,Pennsylvania
www.4anewbeginning.com A New Beginning :: Body wraps - serving the Santa
Cruz, Los Gatos, Watsonville, and Appos areas in California
www.allwrappedup.us All Wrapped Up, Newport, RI - body wraps with Suddenly
Slender, The Body Wrap mineral bodywraps & weightloss products
www.apamperedtouch.com A Pampered Touch, Wilmington, DE - body wraps with
Suddenly Slender, The Body Wrap mineral bodywraps & weightloss products
www.aslenderyoubodywraps.com A Slender You :: Modesto, California - Offering
body wraps, anti-aging and weight loss solutions
www.aurawellness.com Tula Atlanta Health Studios, Piedmont, Atlanta, GA,
body wraps, corporate and private yoga, mineral bodywrap treatments with
Suddenly Slender
www.awrapabove.com A Wrap Above, Body Wrap & Day Spa :: Featuring Body Wraps
and spa services in Newnan, Georgia
www.beslendernow.com Slender Now, Dayton, OH - body wraps with Suddenly
Slender, The Body Wrap mineral bodywraps & weightloss products
www.bodybydesignbodywraps.com www.bodybydesignbodywraps.com:80
www.bodycanvasnv.com Body Canvas :: Featuring Body Wraps and airbrush
services in Reno, Nevada
www.bodyelements.net Body Elements, Fitness & Day Spa :: Featuring Body
Wraps, fitness & Spa services in Seneca, South Carolina
www.bodysculptingbythesea.com Body Sculpting By The Sea, Carmel, CA - body
wraps with Suddenly Slender, The Body Wrap mineral bodywraps & weightloss
products
www.bodytap.us The BodyTap :: Featuring Body Wraps and Spa Services in
Atlanta, Georgia
www.bodywrapgreece.com The Bodywrap of Greece :: Featuring Body Wraps and
Spa Services in Greece
www.bodywrapofcheyenne.com Bodywrap of Cheyenne, Cheyenne, Wyoming -
provider of Suddenly Slender, The Body Wrap mineral bodywraps and weight
loss supplements
www.bodywrapsandmore.com Body Wraps and More, Olive Branch MS - provider of
Suddenly Slender, The Body Wrap mineral bodywraps, weight loss supplements,
skin care, waxing peels, facials!
www.bodywrapsody.com Robyn's Wrapsody of Tampa, FL - Licensed provider of
Suddenly Slender, The Body Wrap mineral bodywrap & weightloss products
www.changeyourshape.com Shape Shifters Body Wraps & More, Cameron Park, El
Dorado Hills, Folsom, Placerville CA - antiaging body wraps with Suddenly
Slender, The Body Wrap mineral bodywraps & weight loss products California
www.charismaslenderspa.com Charisma Spa :: Featuring Body Wraps and Spa
Services in Green Bay, Wisconsin WI
www.dangerouscurves.ca Dangerous Curves Slimming Salon, Burnaby, BC - body
wraps with Suddenly Slender, The Body Wrap mineral bodywraps & weightloss
products
www.dermomedica.com Dermomedica :: Featuring Body Wraps and Spa Services in
Belgrade, Yugoslavia
www.ediessalonpanache.com Edie's Salon Panache of Concord,NC - provider of
Suddenly Slender, The Body Wrap mineral bodywraps, hair styling, hair
coloring, nails and weight loss supplements
www.healthyimage.biz :: Healthy Image Body Wrap of Kingsland, TX - Day Spa,
Hair Salon, Body Wraps with Suddenly Slender mineral bodywraps and weight
loss products.
www.instantlyslimmer.com The Day Spa, Instantly Slimmer Body Wraps,
Ketchikan, AK - Massage, bodywraps with Suddenly Slender, The Body Wrap
mineral bodywrap & weightloss products
www.itsawrapbodysalon.com It's a Wrap of DeSoto, TX - Featuring Body Wraps
and Solutions for Weight Loss
www.ladiesworkoutexpressnj.com Ladies Workout Express :: Featuring Body
Wraps, Fitness Facility & Body Wraps in Franklin Lakes, New Jersey
www.levisagesalon.com Le Visage Salon :: Professional care for your hair,
skin & body. Featuring Body Wraps and airbrush tanning services in Fremont,
California
www.mvbodybalance.com Body Balance :: Featuring Body Wraps in Martha's
Vineyard - Vineyard Haven, and Boston Massachusetts.
www.newimagebodyspa.com New Image Body Spa :: Featuring Body Wraps and Spa
Services in Ann Arbor, Michigan MI
www.olympianbody.com Olympian Body, Olympia, WA - body wraps with Suddenly
Slender, The Body Wrap mineral bodywrap, bodywraps & weightloss products
www.placetorelax.com A Place To Relax, Santa Rosa, CA - body wraps with
Suddenly Slender, The Body Wrap mineral bodywraps & weightloss products
www.rejuvenationspa.com Rejuvenation Spa :: Featuring Body Wraps and Spa
Services in Wayne, PA, Pennsylvania
www.rootandbranch.net Root and Branch Body Wraps of Fair Haven, NJ -
Licensed provider of Suddenly Slender, The Body Wrap mineral bodywrap
www.salonunlimiteddayspa.com Salon Unlimited and Day Spa, Hammond, LA - body
wraps with Suddenly Slender, The Body Wrap mineral bodywraps & weightloss
products
www.sandysbodywrapsplus.com Sandy's Body Wraps Plus, Wilbraham, MA - body
wraps with Suddenly Slender, The Body Wrap mineral bodywraps & weightloss
products
www.savannahswrapsody.com Savannah's Wrapsody :: Featuring Body Wraps in
Blacklick and Columbus, Ohio
www.sensiblewraps.com Scentsible Wraps, Family Therapeutic Massage Center ::
Body Wraps, Spa Services, Massage, Reflexology, weight loss serving Kokomo,
Lafayette, Indianapolis Indiana IN
www.shapelymeasures.com Shapely Measures body wraps, Kissimmee, FL -
bodywraps with Suddenly Slender, The Body Wrap mineral bodywrap & weightloss
products
www.silhouetteslubbock.com Silhouettes Lubbock TX provider of skin care ,
mineral bodywraps, skin care cosmetics
www.slenderella.com SlenderElla, Lawrenceville, GA - body wraps with
Suddenly Slender and airbrush tanning, The Body Wrap mineral bodywraps &
weightloss products
www.slenderhour.com Slender Hour, Body Wrap Spa :: Featuring Body Wraps in
Crystal River, Florida FL
www.slender-solutions.com Slender Solutions, Body Wrap Spa :: Featuring Body
Wraps in Monroe, Louisiana LA
www.slenderwrapssa.com :: Slender Wraps of San Antonio, TX - The Body Wrap
mineral body wraps
www.slimmerbody.biz Slimmer Body California, Glendale CA - provider of
Suddenly Slender, The Body Wrap mineral bodywraps and weight loss
supplements
www.slimmerreflections.com Slimmer Reflections Body Sculpting, Bohemia, NY -
body wraps with Suddenly Slender, The Body Wrap mineral bodywraps &
weightloss products
www.slimmeru.biz Slimmer U Wellness Center, Sunrise, Ft Lauderdale, FL -
body wraps with Suddenly Slender, The Body Wrap mineral bodywraps &
weightloss products
www.slimwrap.com Suddenly Slimmer Body Wraps of Los Angeles, CA, provider of
Victoria Morton's Suddenly Slender The Body Wrap, mineral bodywrap for
inchloss & weightloss products
www.southerntanandwrap.com Southern Tan and Wrap :: Body wraps - serving the
Baton Rouge area in Louisiana
www.spalife.net Spa Life Medi-spa of Valley Cottage, New York - Featuring
Body Wraps, Mesotherapy, Curl lift and Martial Arts
www.spalife.us Spa Life Medi-spa of Valley Cottage, New York - Featuring
Body Wraps, Mesotherapy, Curl lift and Martial Arts
www.suddenlyslenderbc.com Suddenly Slender, The Body Wrap, Vernon, BC - body
wraps with Suddenly Slender, The Body Wrap mineral bodywraps & weightloss
products
www.suddenlyslenderjamaica.com Suddenly Slender Jamaica :: Featuring Body
Wraps, in Kingston, Jamaica
www.suddenlyslenderofcanada.com Suddenly Slender of Canada, Grande Prairie,
Alberta - body wraps with Suddenly Slender, The Body Wrap mineral bodywraps
& weightloss products
www.suddenlyslendersalon.com Suddenly Slender, The Body Wrap, Clearwater
FL - mineral bodywraps, body wraps and weightloss products
www.suddenlyslenderyou.com Suddenly Slender You, Jacksonville FL - provider
of Suddenly Slender, The Body Wrap mineral bodywraps, weight loss
supplementsand detox massage!
www.suddenlyslimmer.biz Suddenly Slimmer of Auburn, AL - Body Wraps, Mineral
Bodywraps and Solutions for Weight Loss
www.suddenlyslimmer.org Suddenly Younger and Slimmer :: Featuring Body
Wraps, Spa and Chiropractic Services, and non-surgical face lifts and
liposuction in Los Alamitos
www.suddenlyslimmerbodywrap.com Suddenly Slimmer, San Diego, CA - body wraps
with Suddenly Slender, The Body Wrap mineral bodywraps & weightloss products
www.sunshinespecialties.net Sunshine Specialties Wellness and Beauty Spa ::
Featuring Body Wraps and massage in Jasper, Indiana
www.tampa.wrapshop.com Robyn's Wrapsody of Tampa, FL - Licensed provider of
Suddenly Slender, The Body Wrap mineral bodywrap & weightloss products
www.thebodywrap.info The Body Wrap of Windsor, Ontario, Detroit, Michigan,
MI - body wraps with Suddenly Slender, The Body Wrap mineral bodywraps &
see from the descriptions, a lot of them have crossovers with stuff like
reflexology, chiro, etc. (No doubt also "Hubbard managed" with
davidsinger.org.)
Laugh for the day was the site "softasstone.com". It was mixed in with all
the body wrap sites. So I figured it must be _Soft Ass Tone_. (It turned
out to be a cement/stone place and really was Soft As Stone. Heh.)
Mike Gormez
<tilman...@snafu.de> wrote in
<e7nup0po43pnrqufb...@4ax.com>:
>The "secret" of "suddenly slender body wrap" of scientologist
>Victoria Morton seems to be pseudomonas aeruginosa
>http://www.pseudomonas.com, really nasty bacteria:
>
>http://www.fda.gov/foi/warning_letters/g4788d.htm
...
Btw, I can find
Suddenly Slender, The Body Wrap
Montreal Que H1X-3K1
in the WISE 1997 directory but not in the 1999 issue.
--
Mike Gormez
- Stop deceptive recruitment into scientology http://stop-wise.biz/
- www.whyaretheydead.net documents the deaths of scientologists
- "There can be no keener revelation of a society's soul than the way it
treats its children." -- Nelson Mandela. Scientologist often attach more
importance to scientology than children www.taxexemptchildabuse.net
Android Cat
> "On Sat, 20 Nov 2004 16:07:04 +0100, Tilman Hausherr
> <tilman...@snafu.de> wrote in
> <e7nup0po43pnrqufb...@4ax.com>:
>
>> The "secret" of "suddenly slender body wrap" of scientologist
>> Victoria Morton seems to be pseudomonas aeruginosa
>> http://www.pseudomonas.com, really nasty bacteria:
>>
>> http://www.fda.gov/foi/warning_letters/g4788d.htm
>
> ...
>
> Btw, I can find
>
> Suddenly Slender, The Body Wrap
> Montreal Que H1X-3K1
>
> in the WISE 1997 directory but not in the 1999 issue.
They seem to have quite a churn rate of franchises. I'd be curious to know
what the indoctrination route is for them verses Stirling-style chiropactors
and dentists. It probably starts off pretty "alternative-health" and
fluffy, but quickly leads into the courses and pressure sales. I'll bet
they lose at lot at that point.
barb
Maybe they <snicker> "wised up?"
--
--barb
Chaplain,ARSCC
"Imagine a church so dangerous, you must sign a release
form before you can receive its "spiritual assistance."
This assistance might involve holding you against your
will for an indefinite period, isolating you from
friends and family, and denying you access to
appropriate medical care. You will of course be billed
for this treatment - assuming you survive it. If not,
the release form absolves your caretakers of all
responsibility for your suffering and death.
Welcome to the Church of Scientology."
--Dr. Dave Touretzky
Peter Alexander
Mike Gormez
<androi...@hotmail.com> wrote in
<qy8od.67$rL...@fe51.usenetserver.com>:
>> Btw, I can find
>>
>> Suddenly Slender, The Body Wrap
>> Montreal Que H1X-3K1
>>
>> in the WISE 1997 directory but not in the 1999 issue.
>
>They seem to have quite a churn rate of franchises. I'd be curious to know
>what the indoctrination route is for them verses Stirling-style chiropactors
>and dentists. It probably starts off pretty "alternative-health" and
>fluffy, but quickly leads into the courses and pressure sales. I'll bet
>they lose at lot at that point.
I have no idea how they do it. Don't underestimate the power of greed
though. Hyping huge incomes with they would work on their own
personalities might be used to sucked them in. People making real money in
MLMs are the people selling 'how to' booklets and tapes to get rich using
the MLM scam, and selling other motivational crap. It is a small clique in
non-scientology MLMs making tons of money of fools they will happily tell
how successful they have become.
Anyhow, I never paid SY much attention and was looking if this was a WISE
story. I do have listed however on www.whyaretheydead.net Nancy Graham
(54) as the owner and operator of Suddenly Slender, a Falls Church
business.