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Public Health Service
HUMAN SERVICES
DEPARTMENT OF HEALTH &
Food and Drug Administration
College Park, MD 20740
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MAR23~
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< Mr. John Morley
President
Inc,
Natural Factors Nutritional Products,
1111 80'h Street S .W.
Suite 100
Everett, Washington 98203
,
Dear Mr . Morley :
Drug
of February 28, 2006 to the Food and
This is in response to your letter
the Federal
U.S.C. 343(r)(6) (section 403(r)(6) of
Administration (FDA) pursuant to 21
Act (the Act)).
Food, Drug, and Cosmetic
claims "Diets low in
Formula with Sytrinol TM is using the
The product Cholesterol
consumed .with
include SytrinolTM Cholesterol Formula
saturated fat and cholesterol that
disease" and
levels and reduce the risk of heart
cholesterol
may
lower
meals
at least two
subject-to
levels ." These statements are not claims
"Helps maintain healthy cholesterol
because they represent
claims subject to 21 U.S.C . 343(r)(1)(B)
21 U.S .C . 343(r)(6), but
condition (i .e., coronary
the risk of a disease or health related
will
reduce
product
the
that
between
a health claim about the relationship
heart disease). FDA has authorized
101.83)'. A
CFR
esters and coronary heart disease (see 21
` Phytosterol and phytostanol
set forth in the
the eligibility and message requirements
meets
that
supplement
dietary
esters and
the relationship between phytosterollstanol
regulation may bear a claim for
of a food or dietary
claim on the label or in the labeling
A
health
disease.
heart
coronary
would
with the requirements in 2.1 CFR 101 .83
supplement that is not in accordance
Moreover,
supplement under 21 U.S.C . 343(r)(1)(B) .
misbrand the food or dietary
.83 subjects
CFR
141
accordance with the requirements in 21
failure to make a claim in
the product is
under 21 U.S.C . 321(g)(l)(B) because
drug
as
a
regulation
to
the,product
disease.
or mitigate a disease, coronary heart
intended to treat, cure, prevent,
respect to
regarding enforcement discretion with
'Also see February 14, 2003 letter
and reduced
claim rule about plant steroUstanol esters
health
interim
use
of
an
expanded
.htm1. http./lwww .cfsan .fda .gov/-drnslds-1tr30
risk of coronary heart disease;
97S 0163-
LET Y70
-uary 28, 2006
..
d and Drug Administration
:e of Special Nutritionals
ter for Food Safety and Applied Nutrition
C Street SW
;hington, DC 20204
_
r Sir or Madam:
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is to provide the required information to comply with our obligation under DSHEA
ling regulations .
plement:
Everett, WA 98203
Phone : (425) 513-8800
Fax :(425)348-9050
Cholesterol Formula with SytrinolT""
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