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), charged with regulating food contact substances (FCS), has simplified the approval process for food packaging and indirect food additives, the process remains detailed and requires significant strategic decision-making to bring products effectively and efficiently to market. Bergeson & Campbell, P.C. (B&C®) professionals, who include in-house chemists, toxicologists, and other scientists, provide clients the legal and scientific know-how to navigate the regulatory process while keeping an eye on the end-goal of consumer appeal.
What We Do
B&C’s professionals have extensive experience assisting clients in obtaining appropriate authority to market FCSs. Our client counsel includes the following:
- Product Review and Interpretations –
- Indirect food additives
- 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
- FCNs
- Recall Assistance
- Food Safety Modernization Act (FSMA) Requirements, Including Audits
- 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
- Assist with and provide guidance on the preparation of all elements of the FCN, including chemistry, safety, and environmental information
- Review draft notifications for sufficiency, and assist with CFSAN responses
- FDA-EPA Jurisdictional Questions –
- Advise clients on matters implicating the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which falls under EPA jurisdiction (e.g., antimicrobial substances in products)
- Federal Food, Drug, and Cosmetic Act (FFDCA) Enforcement –
- Engage in dispute resolution (e.g., stemming from factory inspections) with compliance officers
- Prepare responses to Warning Letters
- Implement corrective action plans
Our Experience
B&C professionals offer clients a combination of legal, 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.
Attorney Jayne P. 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. 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. Narigon helps 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.
B&C often partners with its consulting affiliate, The Acta Group (Acta®). Acta professionals bring technical and business expertise to strategic planning, product approvals, and advocacy. Between B&C’s business and legal professionals and Acta’s scientific professionals, clients have a broad knowledge base to draw from in navigating through the FDA approval process.
Representative Engagements
- B&C has assisted manufacturers in making decisions regarding whether possible FCSs can be regarded as GRAS and possibly exempt from pre-clearance.
- B&C attorneys, chemists, and toxicologists 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.
- B&C attorneys and scientists have advised manufacturers regarding the toxicology and chemistry needed to support a submission and have aided in the preparation of the FCNs.