Download MAR 2 9 2006 Bioengineering Jeffrey L. Williams, MD, MS Member

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HEALTH &
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Public Health Service
HUMAN SERVICES
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Food and Drug Administration
College Park, MD 20740
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MAR 2 9 2006
MD, MS Bioengineering
Jeffrey L. Williams,
Member
Sciences, LLC
Advanced Cardiac Life
Road
4885-A McKnight
suite 405
Pittsburgh, Pennsylvania
15237
'
~stration
the Food and Drug Admi
to
2006
10,
March
letter of
to
Federal Food, Drug, and
This is in response your.C . 343(r)(6) (section 403(r)(6) of the
Life Sciences,
U.S
that Advanced Cardiac
(FDA) p~'suant to 21
states
submission
Your _
CardiovanceTM :
Cosmetic Act (the Act)).
claim for the product
following
the
LLC is making
cholesterol and
lowers a woman's total
exercise
and
diet,
«CardiovanceTM proper
an average of 11% .
LDL (bad) cholesterol
authority
in labeling under the
included
statement
a
a specific
makes clear that
treat, cure, or prevent
mitigate,
21 U.S .C . 343(r)(6)
diagnose,
product
to
suggests
' on maY not claim
are making for this P
you
of that section
that
statement
. The
not meet the
disease or class of diseasesprevent, or mitigate disease .' This claim does is intended for
to treat,
this product
that it is intended
claim suggests that
Dear Dr . Williams :
: 343(r)(6) . This
it is subject to
requirements of 21 U.S .C
321(g)(1)(B), ~d that
.
.S.C
U
of
21
the meaning
intend to make claims of this
you
use as a drug within
If
Act.
the
of
provisions
(CDER),
regulation under the drug FDA's Center for Drug Evaluation and Research Rockville,
contact
Pike,
II, 11919 Rockville
nature, you should
HFD-310, Montrose metro
office of Compliance,
Maryland 20852 .
FR
structure function claims (65
on
rule
final
January 6, 2000
cholesterol," however
'In the preamble to the
believe that "lowers
to
continues
that "FDA
1000 at 1019) FDA stated
disease claim."
qualified, is an implied
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,
3effrey L.
Page 2 - Dr .
Please contact
Williams
be of further
us if we may
assistance.
sincerely yours,
5usan J . Walker, MD
Director
Dietary
Programs
Supplement
of
Labeling
Division
Products,
office of Nutritional
Supplements
and Dietary
Safety
Center for Food
and Applied Nutrition
HFD-310
of Compliance,
Office
and Research, Regulatory Affairs, Office of
Copies:
Evaluation
for Drug
' ioner for
FDA, Center the Associate Conv~ss
FDA, office ofHFC-200
Compliance, HFR-CE140
of
Office
einent,
Bnforc
District Office,
FDA, Philade1ph
Philadelphia
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l 01Vlarch 20 06
Office of Nutritional Products, Labeling
and Dietary Supplements (HFS-810)
Center for Food Safety and Applied
Nutrition, Food and Drug Administration,
S 1 00 Paint Branch Pkwy.
College Park, MD 20740
301-436-2375
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Sir or Madam:
Advanced Cardiac Life Sciences, LLC files this notification of statements of nutritional
support pursuant to section 403(r)(6) of the Federal Food, Drug, and Co smetic Act. This
notification also includes the certification required by 21 CFR Part 101 .93(a)(3).
1 . Name and Address of Supplement Distributor: Advanced Cardiac Life Sciences, LLC,
4885-A McKnight Road, Suite 405, Pittsburgh, PA 15237
2. Text of the Statement that is Being Made : "CardiovanceTM, proper diet, and exercise
."1°2
lowers a woman's total cholesterol and LDL (bad) cholesterol an average of 11%
' 3. ' Name of the Dietary Ingredient or Supplement that is Subject of the Statement :
CardiovanceTI".
4. Name of the Dietary Supplement (including Brand Name) in W11ose Labeling the
Statement Occurs: CardiovanceTm
S. -Substantiation information is on file in the sponsor's office . The company member
that can certify same is Jeffrey L. Williams, MD, MS, Member.
Furthermore, it is hereby certified that the information contained 'in this notice is
complete and accurate, and that the notifying firm has substantiation that the statement is
truthful and not misleading.
Regards,
,1.._.
Jeffre
. Williams, MD, MS Bioengineering
Member
Advanced Cardiac Life Sciences; LLC
:
'Cleeman JI (Corresponding Author), Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults,
"Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection,
Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel IlI)," JAMA, V. 285, No. 19 (May 16, 20(31},
pp. 2486-2497 .
KA, Jones PJH, "Combination Diet and Exercise Interventions for the Treatment of Dyslipidemia: an Effective Preliminary
Strategy to Lower Cholesterol Levels?" Journal of Nutrition, V : 135 (2005), pp. 1829-1835 .
Advanced Cardiac Life Sciences, LlC " Phone/Fax: 877.490:6787 " 4885-A McKnight Road, Suite 405 " Pittsburgh, PA 15237 " infoC cardiovance.com " www.cardiovance.com