BIOTECHNOLOGY 2013 - Key Issues in FDA & FTC Regulation of Dietary Supplements

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Category BIOTECHNOLOGY 2013

Deadline: May 30, 2013 | Date: May 30, 2013

Venue/Country: Online, U.S.A

Updated: 2013-05-03 17:57:17 (GMT+9)

Call For Papers - CFP

While some critics charge that FDA’s oversight of dietary supplements is lax, creating an almost “Wild West” flavor to the industry, the reality is that the FDA has significant authority to enforce an array of legal and regulatory requirements on the dietary supplement industry. These requirements range from review of new dietary ingredients (NDI) to health claims and structure/function claims for dietary supplements, to the agency’s increased sophistication in enforcing the 2007 Good Manufacturing Practice (GMP) requirements applicable to dietary supplement operations.

In this seminar, we will explore FDA’s recent enforcement activity involving dietary supplements and provide insight and guidance to industry members on how to ensure compliance and avoid the FDA’s administrative and judicial enforcement weapons. We also will review the parallel power of the Federal Trade Commission (FTC) to regulate the advertising of dietary supplements and why the FTC may even be harsher than FDA.

Areas Covered by the Seminar:

Overview of dietary supplement regulation

Recent FDA enforcement action on dietary supplement GMPs

Changes in FDA’s New Dietary Ingredient (NDI) requirements

Understanding when claims convert a dietary supplement into a drug and the consequences of the resulting unapproved new drug status

The FTC’s decision in POM Wonderful and its implications for claims substantiation

Who Will Benefit:

Executives and Senior Officials at dietary supplement companies, as well as their suppliers and vendors will benefit from a more detailed understanding of the current FDA hot buttons for dietary supplement regulation, as well as a review of the role of the Federal Trade Commission in regulating dietary supplement advertising. Officials from virtually any part of a dietary supplement should attend the seminar, with particular emphasis from representatives from the following departments:

C-Suite / Senior Executives

Manufacturing

Quality Assurance

Regulatory Affairs

Compliance

Sales

Marketing

Legal

Scientific Affairs

Clinical

About Speaker

Michael Swit has been addressing critical FDA legal and regulatory issues since 1984. Before recently joining Duane Morris LLP as a Special Counsel in its San Diego office, Mr. Swit served for seven years as a Vice President for The Weinberg Group, a premier FDA regulatory consulting firm headquartered in Washington, D.C., where he developed and ensured execution of a broad array of regulatory and other strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for drug, biologic, device, IVD, and other life sciences companies, as well as those in the food, cosmetic, and dietary supplement industries.

Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the Food & Drug Law Journal Editorial Board, Mr. Swit also has been a prominent speaker at numerous conferences sponsored by such organizations as RAPS, FDLI, and DIA.

Speaker : Michael Swit

Product ID : F62329

Schedule Date :

Thursday, May 30, 2013

duration : 01:00 to 02:00 PM EDT

https://compliance2go.com/index.php?option=com_training&speakerkey=50&productKey=236