Current Issues in the Regulation of Dietary Supplements

Why Should You Attend:

As the use of dietary supplements has increased, so have reports of adverse events, either due to adulteration or drug interactions. This has resulted in an increased interest from regulatory agencies, such as the U.S. Food and Drug Administration. The regulation of these dietary supplements falls in between food and drugs. While much of the current regulatory framework is voluntary, it is likely that as time goes by, it will become more and more mandatory. Manufacturers, importers, distributors and retailers of dietary supplements need to be compliant with these regulations.

This webinar will help the attendees learn of their regulatory obligations and the penalties that can accrue for noncompliance. This 90 minute webinar will focus on educating this emerging field and how to comply with your documentation and reporting obligations.

Areas Covered in the Webinar:

• Overview U.S. Current Good Manufacturing Practices (cGMPs) for dietary supplements
• Overview of health claim requirements, including labeling and advertising
• Update on enforcement issues

Who Will Benefit:

• Manufacturers of dietary supplements
• Importers of dietary supplements
• Wholesalers of dietary supplements
• Retailers of dietary supplements
• Pharmacy employees
• Life science industry professionals engaged in the conduct of clinical trials in connection with dietary supplements

Instructor Profile:

Eric B. Alspaugh, Esq., is the owner of the Law Office of Eric B. Alspaugh in Newport Beach, CA. His background includes more than ten years of research and development in pharmaceuticals, medical devices and in vitro diagnostics. He has participated in more than one hundred in vivo studies and human clinical trials around the world. Additionally, Eric has served as patent counsel or general counsel to numerous medical device companies – both public and private. Currently, he works with several medical device companies that are focused on cardiovascular, ophthalmic, and orthopedic treatments. He holds a J.D. from the University of San Diego school of Law and a B.S. in Biology from the University of California, San Diego.

Topic Background:

As the cost of pharmaceuticals has continued to rise, consumers are increasingly turning to dietary supplements to meet their health needs. The US Food and Drug Administration define a dietary supplement as any “product intended for ingestion that contains a "dietary ingredient" intended to add further nutritional value to (supplement) the diet.” These include a wide array of products including: vitamins, minerals, amino acids, herbs and botanicals, a dietary substance for use by people to supplement the diet by increasing the total dietary intake, and concentrate, metabolite, constituent, or extract. A 2011 study from US Centers for Disease Control and Prevention’s National Center for Health Statistics indicated that by 2006, over 50% of the American population use some form of dietary supplement.

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