Jayne P. Bultena

Phi Beta Kappa; Omicron Delta Kappa. Ms. Bultena has almost 20 years of experience in food and drug regulatory matters, including approval, labeling, compliance, and promotion of pharmaceutical and consumer health care products, biologics, diagnostics, medical devices, and dietary supplements. She has counseled Fortune 100 companies, start-ups, and venture capital investors on several 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; advising clients on development of claims, labeling, and promotional materials, including websites, social networking, and clinical medical education (CME); petitioning 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; assisted clients with unique food, dietary supplement, and cosmetic products to market through appropriate regulatory pathways. In addition to representing clients before FDA, Ms. Bultena has represented clients before the CPSC and the FTC.