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When a consumer opens a can of soda or bag of potato chips, they have little knowledge of the scientific and legal resources invested in that can, bag, beverage, or chip. Food packaging, for instance, incorporates a variety of strategic decisions for producers: how well does the packaging preserve the product, how easy is it to distribute, how appealing is it to consumer tastes? Layered atop these decisions is a host of regulatory issues, including packaging safety and labeling accuracy.
While the U.S. Food and Drug Administration (FDA) has simplified the approval process for food packaging and food additives in the U.S., the process remains detailed and requires significant strategic decision-making. Complicating matters for companies marketing products in Europe are regulatory developments brought about by the European Food Safety Authority (EFSA). EFSA has attempted to both simplify the European Union (EU) Framework Regulation as well as synthesize the relevant laws of the EU Member States. This has led to an amending process that has kept the EU regulatory framework in persistent flux. In China, the State Council is undertaking a “crackdown” on food safety measures, which may lead to more onerous requirements for packaging in that country.
What We Do
Acta professionals have extensive experience assisting clients in obtaining appropriate authority to market FCSs in Europe, Asia, and the Americas. Our client counsel includes the following:
- U.S. Regulatory Requirements –
- Determine possible pathways to market outside the FCN process
- E.g., where proposed use does not meet definition of FCS or is exempted
- E.g., where product is Generally Recognized As Safe (GRAS) or is exempted
- Determine possible pathways to market outside the FCN process
- U.S. Center for Food Safety and Applied Nutrition (CFSAN) Submissions (Where FCN Submission Is Necessary) –
- Arrange and participate in pre-submission conferences intended to refine and limit data requirements
- Help determine needed testing
- Review draft notifications for sufficiency, and assist with CFSAN responses
- EU Regulatory Requirements –
- Determine compliance requirements with any EU national legislation depending on Member State
- Help determine needed migration limit testing
- Assist with compliance with Good Manufacturing Practice (Regulation 2023/2006)
- Prepare strategies for supply chain responsibilities
Our Experience
Acta professionals offer clients a combination of regulatory, strategic, and scientific expertise. That combination is key to assisting clients in bringing their products to market, staying on top of regulatory issues, and responding effectively to matters that may arise over the course of a product’s life.
Jayne Bultena has over 20 years of experience in food and drug regulatory matters. She has counseled Fortune 100 companies, start-ups, and venture capital investors across issues, including FDA inspections, responding to deficiencies, and coordinating press and media relations. Ms. Bultena has worked with companies to assess the regulatory options for bringing food contact and packaging materials into the U.S. market. She has represented clients before FDA, the U.S. Consumer Product Safety Commission (CPSC), and the U.S. Federal Trade Commission (FTC).
Richard E. Engler, Ph.D., Director of Chemistry, is a 17-year veteran of the U.S. Environmental Protection Agency (EPA) whose insight into the complex chemistry issues that often arise during the evaluation of FCSs is a powerful asset to clients. His expansive knowledge of physical and organic chemistry equips clients to prepare defensible, scientifically grounded responses to challenges in this space related to migration analysis and substance identity.
Scott J. Burya, Ph.D.,
a Regulatory Chemist with a Ph.D. in analytical chemistry, managed compliance and notification activities for a multinational food contact coating manufacturer and has obtained Food Contact Notifications (FCN), Letters of No Objection (LONO), and other approvals needed to commercialize new products. Dr. Burya specializes in reviewing products with respect to U.S. and European Union food contact regulations, preparing and submitting FCNs, and interacting with regulatory authorities to obtain approvals for FCSs.
Catherina D. Narigonhelps clients navigate a range of complex food additives and FDA issues. Ms. Narigon’s food additives experience includes compliance assistance for good manufacturing processes (GMP), interpretation of applicable regulatory provisions, and client advocacy. Ms. Narigon additionally works with clients on a range of FDA issues expanding beyond food additives, including evaluating active pharmaceutical ingredients (API).
Lindsay A. Holden, Ph.D., DABT, Senior Toxicologist/Regulatory Scientist, supports clients on the strategy and implementation of collecting, interpreting, and applying toxicological hazard data within federal and state regulatory frameworks. She is a board-certified toxicologist with an applied public health, research and development, and regulatory toxicology background under a federal agency with a global footprint.
Lara A. Hall, MS, RQAP-GLP, Senior Regulatory Scientist/Quality Assurance Specialist, and Michelle C. Mims, MS, RQAP-GLP, Regulatory Scientist/Quality Assurance Specialist, are quality assurance specialists who assist clients in placing, coordinating, and monitoring pre-clinical laboratory testing necessary for regulatory submissions, including migration studies for food contact materials and supporting analytical method development and validation.
Representative Engagements
- Acta has assisted manufacturers in making decisions regarding whether possible FCSs can be regarded as GRAS and possibly exempt from pre-clearance.
- Acta professionals have reviewed possible food contact materials to determine if they are covered by regulations in the Code of Federal Regulations (C.F.R.) or possibly precluded by notifications previously declared effective.
- Acta professionals have advised manufacturers regarding the toxicology and chemistry needed to support a submission and have aided in the preparation of the administrative sections of FCNs.
- Our professionals routinely assist clients navigate regulatory issues under Framework Regulation (EC) No. 1935/2004, which address materials and articles intended to come into contact with food.
- Acta regularly counsels on issues arising under Good Manufacturing Practices (GMP) and compliance with Commission Regulation (EC) No. 2023/2006 addressing GMP for materials and articles