Alisa Aija Karlsons

Representative Matters: Successfully filed numerous Food Contact Notifications (FCNs) on a range of packaging substrates and applications; Advised food packaging producers on performing self-determined Generally Recognized as Safe (GRAS) evaluations as a means of establishing FDA compliance of new product lines; Determined 21 C.F.R. 176.170 FDA regulatory compliance of an entire line of paperboard produced by a major foreign paperboard manufacturer, allowing the manufacturer to enter the U.S. market; Counseled a large food contact material manufacturer through a contamination event to minimize risk and supply chain disruptions; Advised food packaging producers on California's Proposition 65, including overseeing development of No Significant Risk Levels (NSRLs) and Maximum Allowable Dose Levels (MADLs), and established exemptions from warning requirements; Assisted PET recyclers in establishing the food-contact compliance of their recycled PET and obtaining no objection letters (NOLs) from FDA; Drafted FDA compliance opinions to assist companies in obtaining certification from NSF; Filed petitions with the European Food Safety Authority (EFSA) and U.K.'s Food Standards Agency (FSA) to clear new plastic materials under the Plastics Regulation; Guided a major polymer producer in communications with customers and conducted a risk assessment of non-intentionally added substances (NIAS) under the EU's Plastics Regulation; Advised a leading manufacturer of coatings on compliance obligations and customer assurance language following implementation of the EU'S BPA Regulation; Counseled clients on good manufacturing practice (GMP) considerations, including conducting GMP audits of client facilities; Prepared and submitted Drug Master Files (DMFs) to FDA on packaging materials for drug products