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FDA approval of a film
April 1, 2008
What exactly is FDA approval for substrates? Well, for starters, FDA does not approve substrates. What they do is to enforce the regulations of the law as defined in the Federal Food, Drug, and Cosmetic Act and additional laws enforced by FDA Code of Federal Regulations–Title 21. In general, films and film additives are treated in Part 177–Indirect Food Additives: Polymers.
So what is FDA approval? Well, it's a legal opinion based on the materials conformance to the laws so you have to have your product documentation for all your substrate components reviewed by a legal firm specializing in this area of the law. They review what you have submitted, suggest testing if necessary and then issue a legal opinion that your substrate meets the requirements of the law. That then is what FDA approval represents.
Posted by Eldridge M. Mount on April 1, 2008 | Comments (0)