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Nutramax Laboratories, Inc. - Initiated use of the combination of glucosamine & chondroitin sulfate Dedicated to qu

Nutramax Laboratories, Inc. - Initiated use of the combination of glucosamine & chondroitin sulfate Dedicated to quality Committed to research to demonstrate effectiveness Over 20 research papers published using Cosamin® DS/Cosequin® specific chondroitin sulfate & glucosamine hydrochloride

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Nutramax Laboratories, Inc. - Initiated use of the combination of glucosamine & chondroitin sulfate Dedicated to qu

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  1. Nutramax Laboratories, Inc. • - Initiated use of the combination of glucosamine & chondroitin sulfate • Dedicated to quality • Committed to research to demonstrate effectiveness • Over 20 research papers published using Cosamin® DS/Cosequin® specific chondroitin sulfate & glucosamine hydrochloride • Specific chondroitin sulfate being used in NIH GAIT Study • Has over 10 years of experience with method development & validation for chondroitin sulfate & glucosamine • - Supports accuracy in testing, truth in labeling

  2. Recommendation Nutramax Laboratories, Inc. recommends that both health claim petitions be denied due to questions and uncertainty related to the proven efficacy and exact composition of the specific materials cited in the petitions.

  3. Two Fundamental Questions 1. What is actually in the bottle? identity: need for specific test quantity: need for accurate test quality: low levels of other materials 2. Does it really work? clinical testing bioequivalence

  4. Glucosamine & Chondrotin • Sulfate Health Claim Petition Issues • No known published bioavailability studies on petitioner’s chondroitin sulfate and/or glucosamine • No known published clinical studies on petitioner’s chondroitin sulfate and/or glucosamine • No evidence provided by petitioner for repair & rebuild claim • Limitation on assays

  5. Chondroitin Sulfate Assay 1. CPC- detects sulfated glycosaminoglycans; lacks specificity 2. Identity- proof that material quantitated by CPC is actually CS 3. Demonstrate absence of other GAGs (purity)

  6. Glucosamine Sulfate Health • Claim Petition Issues • NIH GAIT Study – Chose to study Glucosamine HCl NOT Glucosamine Sulfate • Glucosamine HCl vs. Glucosamine Sulfate • Assay Issues • Form of Glucosamine Sulfate

  7. Assay Issues – Glucosamine Sulfate 1. Glucosamine hydrochloride used as reference 2. Lack of specificity in assay submitted by petitioner 3. Need for uniformity in methods

  8. Glucosamine Sulfate Form 1. For what form of glucosamine sulfate (i.e., production method) is the health claim petition applicable? 2. Are mixed salts or co-crystals equivalent (stability) to the original sulfate salt? 3. Actual content of glucosamine base or hydrochloride should be stated on label

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