Dietary Supplement Claims Subject To FDA "Cour&esy" Letters
This article was originally published in The Tan Sheet
Executive Summary
Dietary Supplement Claims Subject To FDA "Courtesy" Letters
Dietary Supplement
Claims Subject To FDA "Courtesy" Letters
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"Courtesy" letters,
or "letters of objection," are sent by FDA to notify
dietary supplement companies of claim provision
violations under the Dietary Supplement Health &
Education Act; F-D-C Reports, Inc. compiled the
redacted list from information recently made available
by the agency.
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Company
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Product/Ingredient
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Date
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Avon
Products
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Vitadvance
Cold Season Liquid
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8/4/04
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"In the
context of the statements being made for this product,
the use of the term 'Cold Season' in the product name
is an implied disease claim" suggesting the product is
intended to treat, prevent, mitigate or cure the common
cold.
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CCA
Industries
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Mega-T
Chewing Gum
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8/4/04
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The product
is a conventional food rather than a dietary
supplement, as defined by the FD&C Act. Therefore
it must bear nutrition labeling in accordance with
conventional food regulations and may make only claims
that may be made for conventional foods. Additionally
"any ingredient intentionally added to a conventional
food must be used in accordance with a food additive
regulation unless it is generally recognized as safe
(GRAS)."
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Natural
Factors
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Slim Styles
Weight Loss Drink Mix with PGX
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8/4/04
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As a "drink
mix intended for meal replacement," the product
"appears to be represented for use as a conventional
food and is not a dietary supplement." Therefore it
must bear nutrition labeling in accordance with
conventional food regulations and may make only claims
that may be made for conventional foods.
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Nutritional
Specialties
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Life Time
Garli Dophilus Capsules
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8/4/04
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Because a
claim that the product "helps maintain...normal
cholesterol levels" does not "include a statement about
it being intended to affect blood cholesterol levels
that are already in the normal range, it is an implied
disease claim."
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Physician
Health Network
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Female Care;
Glucosamine/Chondroitin; Inflammation Formula; Kava
Kava Extract; L-Carnitine; MSM Capsules
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8/4/04
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Claims made
for the products "suggest that they are intended to
treat, prevent or mitigate diseases such as injuries
and wounds, joint disease and high cholesterol and
heart disease." The products appear to be intended for
use as drugs and are therefore subject to regulation as
drugs.
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