Answer: Aside from original FCNs, which were allowed to become effective in place of existing petitions, an FCN can only cover one uncleared FCS. If a company is interested in using a product that contains more than one uncleared substance, a separate FCN must be filed for each uncleared FCS. This issue is likely to be the subject of considerable discussion, because there is no apparent reason why a notification could not cover more than one substance, particularly in the case of formulations.
Not all components of an FCS, however, require separate FDA clearance (e.g., substances needed to make a basic resin, like catalysts); the question of which components need clearance is being addressed by FDA on a case-by-case basis.
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