**To: Food & Drug Administration -- Food Advisory Committee**

**From: Nutramax Laboratories, Inc. -- Edgewood, Maryland**

**Date: May 28, 2004**

**Re: Written Comments at Public Meeting -- June 7 & 8, 2004**

**Health Claim Petition: Glucosamine & Chondroitin Sulfate &
Osteoarthritis filed by Weider Nutrition International Inc. Docket No.
2004P-0059**

We appreciate the opportunity to submit these written comments to the
Food & Drug Administration Food Advisory Committee for the above
referenced public meeting and health claim petition.

There are four fundamental issues in the Weider petition that should be
considered from the scientific perspective:

1.  In the process of selecting a material for a multi-center study
    (Glucosamine/Chondroitin Sulfate Arthritis Intervention Trial^1^),
    the NIH conducted an extensive evaluation of sources of chondroitin
    sulfate because of the variability in material available in the
    marketplace. They evaluated material from both the United States and
    abroad. After careful evaluation of blinded samples analyzed by
    various laboratories, the NIH selected the 95% minimum purity
    chondroitin sulfate manufactured by Bioiberica S.A. Currently this
    NIH multi-center study is ongoing. This specific chondroitin sulfate
    is not used by the petitioner and to the best of our knowledge no
    clinical studies have been conducted and published on the
    petitioner's specific material.

2.  The majority of published clinical studies conducted on chondroitin
    sulfate alone were performed with specific, highly purified 95%
    minimum material from Bioiberica S.A.^2-10^ This specific
    chondroitin sulfate combined with glucosamine hydrochloride has also
    been used in several additional clinical studies on human
    subjects^11-17^, companion animals^18-25^, research animals^26-29^,
    as well as basic biochemical^30-33^ and bioavailability
    studies^34-35^. No information is provided by petitioner to support
    the assumption that these same results are obtained with less
    purified, less characterized forms of chondroitin sulfate. The forms
    available to the public, differ considerably in source, sulfated
    disaccharides, molecular weight, and purity, and often fail to meet
    label claims^37^. Bioavailability in humans has been shown with the
    higher purity chondroitin sulfate^36^ but not on the material used
    by the petitioner. The presumption of a similar bioavailability and
    clinical response from the various chondroitin sulfate sources
    currently available to the public is unjustified.

3.  The petitioner, through a letter from its attorney, states that
    "*the evidence is extremely strong of an actual disease reducing
    effect: repair and rebuilding of the cartilage matrix."* There is no
    claim or direct data in the petition that substantiates this
    statement and yet the petitioner gives it considerable weight by
    virtue of the wording in the last letter from the petitioner to the
    FDA.

4.  The petitioner relies solely on the CPC (cetyl pyridinium chloride)
    method to assay chondroitin sulfate, with no procedure to prove
    identity. The CPC method detects **sulfated** glycosaminoglycans,
    which could be forms other than chondroitin sulfate. While they cite
    methods that use the CPC to detect sulfated GAGs, they do not
    address the issue of proof of identity, i.e., that what is being
    measured is actually chondroitin sulfate. The chondroitin sulfate
    supplement industry as a whole suffers from a lack of uniformity and
    full validation of acceptable methods. Until this issue is resolved
    and consumers can actually rely on labeling and claims of joint
    support from all manufacturers, it is inappropriate to allow a
    health claim on a material that in most products lacks careful
    characterization, especially regarding identity, source and
    substantiation of bioequivalence and effectiveness.

*For questions, please contact: Kristen E. Blanchard, Vice President,
Legal & Government Affairs, Nutramax Laboratories, Inc., 2208 Lakeside
Boulevard, Edgewood, Maryland 21040*

*Phone: 410-776-4000, Fax: 410-776-4053, e-mail:
<kblanchard@nutramaxlabs.com>*

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