Jayne P. Bultena
Jayne Bultena is a Bergeson & Campbell, P.C. (B&C®) attorney who focuses on food, drug, medical device, and consumer product law and regulation. Having been an associate and partner at premier, nationally known law firms, she has over 20 years of experience in food and drug regulatory matters, including approval, labeling, compliance, and promotion of consumer health care products, biologics, diagnostics, food, and dietary supplements.
- Worked with a Fortune 100 company to audit and proactively change its internal practices and standards for awarding grants, conducting CME, and selecting and training key opinion leaders.
- Worked with a consumer product company and the FDA to identify and recall a major consumer over-the-counter (OTC) drug that had been diverted and sold into the gray market with counterfeit packaging.
- Worked with start-up companies to assess the regulatory requirements for novel, new products, including in vitro diagnostics and research-use-only products.
- Assisted a Fortune 100 company in developing compliant labeling and marketing claims for a new line of over 25 dietary supplement products.
- Helped a Fortune 100 company to develop dual dietary supplement and OTC drug labeling for two market leading products and successfully defended the labeling and marketing claims at both FDA and the FTC.