Alisa Aija Karlsons

Alisa Karlsons counsels packaging and food-contact material manufacturers on U.S. Food and Drug Administration (FDA) compliance obligations, including state-level requirements, such as California’s Proposition 65. She assists companies in bringing new food-contact materials to market, such as paper, plastics, adhesives, and coatings, as well as additives used in these materials. She is experienced in establishing the FDA compliance of recycled paper used in food-contact applications and obtaining letters of no objection from FDA on recycled plastics. Alisa also has extensive experience in advising companies that manufacture materials used in food-processing facilities, such as filtration materials and lubricants. She also helps clients confirm regulatory compliance or obtain new clearances for their food-contact materials in international jurisdictions, including the European Union (EU), Canada, South America, and China.  

As counsel to trade and industry associations, Alisa provides strategic advice to further the policy interests of companies in the food packaging supply chain.

Alisa is a contributing author to packaginglaw.com, which provides news and analysis on worldwide packaging regulations, and she is a frequent presenter at Keller and Heckman’s Paper Packaging Law Seminar.

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