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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), charged with regulating food contact substances (FCS), has simplified the approval process for food packaging and 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 polymer chemists 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:
- 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
- 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
- Review draft notifications for sufficiency, and assist with CFSAN responses
- FDA-U.S. Environmental Protection Agency (EPA) Jurisdictional Questions –
- Advise clients on matters implicating 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 almost 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).
Senior Regulatory Consultant 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 15 years of industry experience are a tremendous asset to clients in matters regarding food contact notifications.
R. David Peveler, Ph.D., holding a Ph.D. in organic chemistry, is expert in product regulatory compliance, FDA food contact and packaging matters, and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) product registration and labeling matters. Prior to joining B&C, Dr. Peveler served as a consultant to Evonik Degussa Corporation and as Senior Regulatory Scientist with Chemtura Corporation. His portfolio includes directing research in a variety of areas involving polymer additives, including PVC heat stabilizers and polymeric plasticizers, and antioxidants for polyolefins.
Jane S. Vergnes, Ph.D., DABT®, a toxicologist with a Ph.D. in Human Genetics and 25 years of experience with global chemical companies, advises clients on the science and strategy needed to demonstrate that materials are safe for the intended FDA-regulated use. Dr. Vergnes offers considerable expertise in designing and monitoring toxicology studies for diverse materials, including food packaging, lubricants for food processing machinery, preservatives, personal care ingredients, pharmaceutical excipients, and tablet coatings.
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 Food Contact Notifications (FCN), Letters of No Objection (LONO), and other approvals needed to commercialize new products. Dr. Burya specializes in the review of FCSs per FDA and European Union (EU) regulations, dietary exposure calculations, compliance testing requirements, and notifications to global regulatory agencies, including FDA, the European Food Safety Authority, and Health Canada.
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 administrative sections of FCNs.