date:Jun 08, 2015
ical product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (4) of the FDC Act applies. In our review of these petitions, we did not consider whether section 301(ll) of the FDC Act or any of its exemptions apply to food containing this additive. Accordingly, this final rule