MAY - 3 2006 Suite 406

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
College Park, MD 20740
MAY - 3 2006
Ms. Adriane Scherrer
COO
Gindan Neutra-Ceuticals ; Inc .
2 North Main Street
Suite 406
Middletown, Ohio 45052
Dear Ms. Scherrer :
This is in response to your letter of April 20, 2006 responding to our March 14, 2006 letter
concerning claims you were making in the labeling of the product Cholest-Low.
We appreciate the steps you have taken to address the issues raised in our previous letter .
However, your brochure still retains a claim that suggests that your product is intended for
use as a drug . In our previous letter; we identified the claim "Recommended for those with a
family history of heart or circulatory problems" as a claim that implied that the product was
intended to prevent heart disease. This claim is retained in the revised brochure you
submitted with your April 20, 2006 letter. We continue to believe that this claim implies that
the product is intended to prevent heart disease and is, therefore, a disease claim that subjects
your product to regulation as a drug. As we have previously stated, disease claims do not
meet the requirements of 21 U.S.C . 343(r)(6). The claim identified above suggests that this
product is intended for use as a drug within the meaning of 21 U.S .C . 321(g)(1)(B), and that
it is subject to regulation under the drug provisions of the Federal Food, Drug, and Cosmetic
Act.
Please contact us if we may be of further assistance .
Sincerely yours,
Susan J. Walker, M.D .
Director
Division of Dietary Supplement Programs
Office of Nutritional Products, Labeling
and Dietary Supplements
Center for Food Safety
and Applied Nutrition
97S 0 163
LET YF4/
Page 2 - Ms. Adriane Scherrer
Copies :
FDA, Center for Drug Evaluation and Research, Office of Compliance, HFD-310
FDA, Office of the Associate Commissioner for Regulatory Affairs, Office of
Enforcement, HFC-200
FDA, Cincinnati District Office, Office of Compliance, HFR-CE440
GINDAN NEUTRA-CEUTICALS, INC .
--
7
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Susan J. Walker M. D.
'
Director
Division of Dietary Supplements Programs
Office of Nutritional Products Labeling & Dietary Supplements
Center for Food Safety & Applied Nutrition
College Park, Maryland 20740
,~f~- ?_ 7 2006
April 20, 2006
Dear Ms. Walker;
We have taken seriously your letter stamped March 14, 2006 concerning the
brochure and packaging of our proposed product . We have, therefore
reconfigured the brochures that we previously submitted for your comments and
are currently designing our sales training program as well as our packaging to
reflect the same direction .
'
In all our activities concerning Gindan's Neutra-ceuticals we will highlight the
statements that the product only maintains already healthy cholesterol and blood
pressure levels .
Since we currently have redesigned the brochure and the training materials as
well as the packaging will take a little longer, we are submitting this new brochure
to your attention now. This is in the hopes that our 75-day notice can be
considered as per your receipt of this memo and our brochure draft. We will
follow-up with a new layout of the packaging .
'
We appreciate the activities of the Food and Drug Administration and wish to
comply with your guidelines 100% .
I,
!
Sincerely,
Adriane Scherrer
COO
I
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'
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2 North Main Street
Suite 406
'
Phone: 513-705-4100
'
Middlerown, Ohio 45042
Fax: 513-433-2024
Email :ascherrer~asiscom .net
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MiddCommons Centre
2 North Main Street
Suite 406
Middletown, Ohio 45042
OiNDAN
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