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Department
of Health and Human Services
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Public Health Service
Food and Drug Administration
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Southwest Region
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100
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January 20, 2005
AMENDED WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Dennis Gay
Chief Executive Officer
Basic Research, LLC
5742 W. Harold Gatty Drive
Salt Lake City, Utah 84116
Ref#: Den 05-06 Amended
Dear Mr. Gay:
We are amending our Warning Letter of January 14, 2005 to include your products
Mamralin-ARa, and TestroGel and are re-issuing the letter with a January 20,
2005 date. Your expected date of response for all five products is now extended
to fifteen working days after this date.
This letter is in reference to your firms marketing and distribution
of StriVectin-SD, StriVectin-SD Eye Cream, Dermalin-APg, Mamralin-ARa, and TestroGel.
The Food and Drug Administration (FDA) has reviewed the labeling for these products,
including your websites at www.kleinbecker.com and www.strivectin.com. FDA has
determined that your products StriVectin-SD, StriVectin-SD Eye Cream, Dermalin-APg,
Mamralin-ARa, and TestroGel are promoted with claims that cause the products
to be drugs under section 201 (g)(1)(C) of the Federal Food, Drug, and Cosmetic
Act (the Act) (21 U.S.C. 321(g)(1)(C)).
As defined in section 201 (g)(1)(C) of the Act, the term drug means
articles (other than food) intended to affect the structure or function of the
body. The labeling for your products includes several claims that demonstrate
that these products are intended to affect the structure or function the body
(structure/function claims). Examples of some of the structure/function claims
observed in your products labeling include:
StriVectin-SD:
- Intensive Concentrate For Existing Stretch Marks (Striae
Distensae)
- Clinically Proven to Dramatically Reduce the Appearance
of Existing Stretch Mark Length, Depth, Texture, and Discoloration
- Optimum Glycosaminoglycan and Collagen Synthesis
- Better than Botox®?
- A stretch-mark reducing emulsion . . . to diminish
fine lines, wrinkles and crows feet.
- [S]uperior wrinkle-reducing properties of a patented
oligo-peptide (called Pal-KTTKS)...on 'photo-aged skin... [A] key ingredient
in the StriVectin cream.
- [S]ignificant improvement in wrinkle depth,
length, wrinkle volume . . . .
- Pal-KTTKS solutions effectiveness at reducing
the appearance of fine lines and wrinkles...
- StriVectin-SD actually increases the synthesis of
new collagen (StriVectin-SD increases collagen I synthesis by 117%, increases
collagen IV synthesis by 357%, and increases glycosaminoglycan synthesis by
267%), making your skin; thicker and firmer.
StriVectiu-SDs clinically proven, proprietary compounds will produce
a visible reduction in actual length, size, depth, feel, color, and rough
texture of your existing wrinkles and/or stretch marks.
- [R]educe wrinkles by as much as 68%, . . . and reduce
the actual length depth, volume, and surface area of stretch marks/wrinkles.
Q: Can StriVectin-SD® help with acne scars and other types of scarring?
A: Yes.... StriVectin-SD users have reported improvement in acne scars, burn
scars, chicken pox marks, scars from old injuries, etc.
- 93% of the subjects tested saw a dramatic difference
in the depth, length, feel, color, and texture of stretch marks.
Repair Existing Stretch Marks
[C]linical observations further document the independent active StriVectin-SD
isolates dramatically:
- Decreased the actual length of striae (stretch marks)
- Decreased the depth of indented surfaces
- Increased smooth surfaces
- Increased skin thickness
- Increased skin firmness
- Increased stimulation of collagen synthesis
- Corrected irregularities in skin coloration
StriVectin-SD: The Most Effective Stretch Mark Repair Compound Ever
Developed
- [P]roven ability to significantly eradicate the
scarred striations of stretch marks.. . .
StriVectin-SD Eye Cream (www.strivectin.com):
- Same active formula as the original StriVectin-SD®
. . ..
- StriVectin-SD (the stretch-mark-reducer-turned-anti-wrinkle-phenomenon
- [S]ignificant decrease in your existing wrinkles or
stretch marks . . . .
Dermalin-APg (www.kleinbecker.com):
- "The next-generation trapsepidermal fat emulsifying
gel
- Penetrating Gel Emulsifies Fat On Contact
- Dissolves Deep-Stored Body Fat Wherever Applied.
- [R]educes the accumulation of age-related
body fat around your waist and abdomen.
- [A]ctually reduce the size of saddlebag
thighs.
- [P]enetrate the skin and shrink a womans thigh.
- [R]eleases fat stores from any problem area. When
the fat is released from the back of a womans thigh, the dimpled appearance
disappears because tension on the connective tissue is reduced as stored depot
fat is released. However, when the gel is applied to the
tummy, waist or hips, a dramatic reduction of stored body fat occurs . . .
- Just apply.. . to your waist or tummy and watch them
shrink in size within a matter of days.
- Wherever youve got those unsightly lumps and
bumps, apply Dermalin-APg and theyre gone.
- [F]orces the fat out of adipose tissue cells . . .
- [O]ne problem area at a time, until youve literally
melted the fat and molded your body into a more pleasing shape.
Mamralin-ARa (www.Kleinbecker.com)
- "[D]esigned to protect a womans breasts from
sag and shrinkage caused by weight loss
- The Adenosine Receptor Agonists (ARAs) in Mamralin-ARa
are designed to protect (and in many cases increase) the figure-enhancing
fat stores in your bust...
- [I]nhibiting lipolysis (the process that causes the
breast to release stored fat) and simulating fat uptake and retention.
- [M]akes it difficult for your body to deplete the
fat stores in you breast for energy . . .maintaining (and in many cases increasing)
the figure-enhancing fat stores in your bust . ...
- [H]elping you get rid of the excess, unwanted fat
stored in your hips, thighs, abs, and buttocks . . . .
- [A]pplying Mamralin-ARa twice a day is the best way
to avoid diet induced breast sag and shrinkage.
TestroGel (www.kIeinbecker.com)
- TestroGel for Sexual Enhancement
- [Q]uickly raising androgen levels to give you (and
your partner) the sexual confidence, stamina, and intensity it takes to truly
satisfy.. -and be satisfied.
- Testosterone-Boosting Gel . . .
- [R]aise your testosterone levels without a doctors
prescription . . .
- Increase Testosterone Without Raising Estradiol Levels
- [S]uddenly become bigger, more ripped, more powerful,
and more aggressive . . ."
- [H]ave more muscle mass, more strength, and less body
fat . . .
- [A] clinically verified alternative to prescription
performance enhancers.
Furthermore, your products are not generally recognized as safe and effective
for the above referenced uses and therefore, the products are considered new
drugs under section 201(p) of the Act. New drugs may not be legally marketed
in the U.S. without prior approval from FDA [section 505(a) of the Act].
This letter is not intended to be an all inclusive review of all claims, labeling,
or products your firm markets. It is your responsibility to ensure that all
products marketed by your firm comply with the Act and its implementing regulations.
We request that you take prompt action to correct these violations. Failure
to promptly correct these violations may result in enforcement action without
further notice. The Act provides for the seizure of illegal products, injunctions
against the manufacturer and/or distributor of illegal products, and criminal
sanctions against persons responsible for causing violations of the Act.
Please notify this office in writing within fifteen (15) working days of the
receipt of this letter as to the specific steps you have taken to correct the
stated violations, including an explanation of each step being taken to identify
violations and make corrections to ensure that similar violations will not recur.
If the corrective action cannot be completed within 15 working days, state the
reason for the delay and the time frame within which the corrections will be
implemented.
Any reply should be sent to the attention of Compliance Officer Shelly L. Maifarth
at the above address.
Sincerely,
/s/
B. Belinda Collins
District Director