2004N-0257 - Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
FDA Comment Number : EC1
Submitter : Mr. Warren Majerus Date & Time: 08/18/2004 07:08:44
Organization : Pharmore Ingredients
Dietary Supplement Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
We import a dietary supplement ingredient called Chondroitin Sulfate. It is derived from bovine cartilage. This cartilage is found in the trachea, floating rib and nasal septum. Since cartilage is not in any of the body parts restricted under the proposal, we feel that the record keeping requirement should not apply to our product.
A letter on file from our foreign manufacturer stating "only bovine cartilage is used as a raw material source for chondritin sulfate" should be sufficient to meet the requirement.