Answer: It is to be expected that FDA will require sufficient information on catalysts and other polymerization aids (initiators, chain terminators, chain transfer agents, and polymerization solvents, for example) to determine that the intended use of the aids does not make the finished polymer unsafe. This type of information generally was required by FDA to support Food Additive Petitions, at least in recent years. The specific data required on polymerization aids will vary from case to case.
Therefore, once a notification has become effective, changes in polymerization aids are permissible, in our opinion, without notice to FDA, as long as a change does not result "in substantive changes in the identity of the product or its impurities, and/or levels or impurities," in the language of FDA's FCN guidance.
In drafting the FCN, language describing the manufacturing process should provide latitude in using alternative polymerization aids.
Back to FAQs