• The only timely and comprehensive book covering food and drug law
• Go-to resource for these topics
• Practical road map for a complex area of law
• All-in-one source

The tenth edition of Food and Drug Law features

• Latest legislative enactments (opioids)
• Criminal and civil enforcement strategies (kratom seizure, executive liability, bogus sleep studies)
• Medical device regulations (postmarket updates)
• Human drug regulation (opioids, right-to-try legislation, innovation-digital, 3-D, cannabis, off-label enforcement)
• Biotechnology regulation (biosimilar marketplace entry)
• Veterinary products regulation (warning letters)
• Personal care products regulation (talcum powder litigation)
• Food regulation (“love” warning letter, pathogens, recalls, GMO disclosure law, food supplier liability)
• Dietary supplements (kratom)
• Tobacco regulation (youth e-cigarette & flavor epidemic, cigars, menthol)
• And many more!

• The regulated industry, such as legal counsel and regulatory affairs personnel searching for concise explanations of relevant portions of the Food, Drug and Cosmetic Act (FDCA)
• Legal practitioners in issues involving food, medical devices, drugs, biologics, cosmetics, veterinary, dietary supplements and tobacco
  products regulatory law
• Government personnel—federal, state, and local—involved in these topics
• Attorneys in related disciplines who find themselves in the crosshairs of the FDCA
• The academic community, including medical, pharmacy, law, and regulatory affairs

Roseann B. Termini, Esq., has more than thirty years of extensive experience in food and drug law. Further, she has published on a broad array of specialized food and drug law issues such as corporate accountability, criminal liability, enforcement, health claims, supplements, safety, duty to warn, preemption, regulation, promotion, tobacco, stem cells, risk assessment and globalization. She is a speaker nationally and internationally and was the first awardee of the Plain English Award. Termini initiated the inaugural online food and drug law courses at Widener University School of Law and the direct-to-consumer promotion at St. Joseph’s University executive program. She served as the sole corporate counsel for an FDA-regulated company and senior deputy attorney general, Pennsylvania Office of Attorney General. Besides her professional association committee appointments, she served on the President’s Council at Immaculata University, served as Food and Drug Law Institute Committee Chair, and is a member of the Central Atlantic Association of Food and Drug Law Officials. Ms. Termini is co-chair of the Health Law Committee of the PA Bar Association and was admitted to the Bar of the United States Supreme Court in 2018.

Food and Drug Law: Federal Regulations of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products, Tenth Edition

Item #: 1000110
ISBN: 978-0-9843561-8-8
Pages: 575p.
Hein-authorized sale price………$199.00 $189.00
Published: FORTI Publications, 2019
Distributed: Getzville; William S. Hein & Co., Inc.