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.

Ms. Bultena has counseled and represented clients across the entire spectrum of industries under the regulatory auspices of the U.S. Food and Drug Administration (FDA). In this regard, she has worked with businesses from start-ups to Fortune 100 companies, products from prescription drugs to dietary supplements, and tasks from complicated compliance audits to management of press relations.

Ms. Bultena has counseled a wide variety of organizations as well as venture capital investors on issues including:

• Managing compliance risks and promotional violations, including FDA inspections.

• Responding to deficiencies and warning letters, conducting recalls, and coordinating press and media relations.

• Development of claims, labeling, and promotional materials, including websites, social networking, and clinical medical education (CME).

• Petitioning the FDA on changes in patent restoration terms, barring use of volunteers for certain clinical testing, supporting regulation of tobacco products, and clarifying orphan drug designations.

• Bringing unique food, dietary supplement, and cosmetic products to market through appropriate regulatory pathways.

In addition to working on behalf of clients before the FDA, Ms. Bultena has represented clients before the Consumer Product Safety Commission (CPSC) and the Federal Trade Commission (FTC).

Representative Engagements:

• 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.