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
    • Direct 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
  • 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).

Director of Hazard Communication and International Registration Strategy Karin F. Baron, M.S.P.H., has an extensive track record of chemical regulatory work. Prior to joining B&C, she served as manager of FDA compliance for a major specialty chemical company, among other roles, and her 20 years of industry experience are a tremendous asset to clients in matters regarding food contact notifications (FCN).

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.

Todd J. Stedeford, Ph.D., DABT®, ERT, ATS, Of Counsel, delivers exceptional legal acumen and scientific experience to firm clients developed over a 20-plus year career spanning international laboratory research; corporate and federal legal appointments; industry health, safety, and environment (HS&E) positions; and scientific leadership of U.S. federal agencies. He provides expertise in dietary exposure considerations, evaluation of appropriate toxicological testing, and dietary risk assessment. In addition to preparation of the safety narrative and comprehensive toxicology profiles.

Toxicologist and Regulatory Scientist Alexander E. Howard, MS, assists clients with testing necessary for regulatory compliance, including ecotoxicology, physical chemistry, and fate and effects studies, and performing hazard and risk assessments on new and existing chemicals for both human health and environmental endpoints. He is well versed in toxicological parameters that impact dietary exposure considerations.

Scott J. Burya, Ph.D., a Regulatory Chemist with a Ph.D. in analytical chemistry, managed compliance and notification activities for a multinational coating manufacturer and has obtained FCNs, Letters of No Objection (LONO), and other approvals needed to commercialize new products. Dr. Burya specializes in the review of elements of the FCN and is knowledgeable in international approaches to FCSs.

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.