SupplySide

NUTRITION SCIENCE ADVISORY BOARD

SESSIONS

• Location: Meadowlands Expo Center – Room A
• Speaker: Jeffrey A. Stassi, program manager for dietary supplements, Covance Laboratories

A critical aspect to assessing the quality of a dietary supplement is the extent to which the product will retain the same physical and chemical properties from time of manufacture to time of consumption. Stability studies are becoming a way for companies to provide data to support shelf life claims, as well as to help develop better and more stable products. Each stability study is a custom set of test procedures and evaluations to assess how the product will remain stable until the expiration date. There are also ways to accelerate the study to predict product stability by increasing temperature and humidity conditions in a controlled experiment. Although stability studies are a voluntary act by the manufacturer, this presentation will provide some detail around designing and understanding the process of developing a protocol that is a meaningful and scientifically valid approach to assessing stability. With increasing regulatory complexity, an unstable economy and decreased consumer spending, it is imperative for companies to be competitive and provide quality products to the marketplace.

• Location: Meadowlands Expo Center – Room A
• Speaker: Zoë Gardner, M.S., research fellow and program coordinator – medicinal plant program, University of Massachusetts

Concerns on the safety of botanical dietary supplements have been raised by health care professionals and regulatory agencies as consumer interest in these products has increased. These concerns include the relative safety of individual herbs, the potential for drug interactions, and the safety of use in pregnant and nursing women. A scientific evidence-base is required for sound clinical and regulatory decision making and for accurate product labeling. Under the guidance of an expert advisory panel, a systematic review of the literature on the safety of approximately 600 botanical dietary supplements has been completed, providing an understanding of safety through organization of data available from clinical trials, pharmacological and toxicological studies, case reports and historical texts. This review separates actual from theoretical safety concerns and addresses many myths and misconceptions that have become common in the popular and scientific literature. Many of the findings support empirical data from the traditional use of herbs, and also address newer concerns regarding herb-drug interactions. This review provides assurance for the safety of many botanicals and clearly defines safety concerns for other botanicals.

• Location: Meadowlands Expo Center – Room A
• Speaker: Darryl Sullivan, immediate past president, AOAC International; director of scientific affairs – analytical chemistry, Covance Laboratories

The development of scientifically validated analytical methods is critical to product quality, testing, GMP compliance, and many more important areas. Analytical methods have been validated for only a fraction of the ingredients used in the dietary supplement industry. More are in development, and more are likely to be added to the list. This session will provide the latest update on methods currently being validated and ingredients next on the list.

• Location: Meadowlands Expo Center – Room A
• Speaker: Amy Eichner, Ph.D., manager – drug reference department, U.S. Anti-Doping Agency

Athletes who push themselves to the limits often rely on supplements to help them sustain a high level of performance. But, according to USADA, in order to get the benefits of a supplement, they may place themselves at some risk. Anti-doping agencies around the world are advising athletes NOT to use supplements. Come to this session to understand why USADA considers supplements a topic of high priority for athletes (at all competition levels) and general consumers. This session will define the problem, and discuss steps the industry can take to make supplements safer and regain the confidence of athletes and consumers.

• Location: Meadowlands Expo Center – Room A
• Speakers: Judy Blatman, senior vice president, communications, Council for Responsible Nutrition; Steven M. Mister, Esq., president and chief executive officer, Council for Responsible Nutrition

The supplement consumer has been portrayed in the press as one who makes a choice between popping pills and eating smartly. A new report from the Life…supplemented consumer wellness initiative turns that myth on its ear. In a nation of "WannaBeWells" and "OhWells," learn where supplement consumers rank on the wellness scale. Plus, find out more about the nine health care practitioner populations surveyed, and learn what supplements physicians, nurse practitioners, registered dietitians and pharmacists take and recommend. Join the Council for Responsible Nutrition's Steven Mister and Judy Blatman as they present this significant new research and demonstrate the impact it is having with journalists, bloggers and online wellness communities.

• Location: Meadowlands Expo Center – Room A
• Moderator: Devon Powell, chief operations officer, American Herbal Products Association
• Speakers: Amy Caplette, quality assurance supervisor group leader, Amway Global Nutrilite Products; H. Scott Rosenbush, business manager – botanicals, PL Thomas & Co.

For dietary supplement manufacturers, ingredient supplier qualification is costly, complex and not well defined in the GMP regulation (21 CFR Part 111). The ingredient Certificate of Analysis (COA) is a critical aspect of the supplier-manufacturer interface. There are no accepted industry standards for dietary supplement component or ingredient COAs. Following on the heels of the SIDI™ protocol, the Joint SIDI Working Group has developed a voluntary COA Guideline, the intent of which is to serve as a guide to the type and scope of information that should appear on a COA for a component or ingredient for use in the manufacture of a dietary supplement. Part of the supplier qualification process involves verifying the accuracy and reliability of the ingredient COA content, and manufacturers of dietary supplements rely on suppliers' COAs for their own manufacturing processes. Therefore, accurate, clear, concise COAs containing the appropriate information are critical for GMP compliance of the dietary supplement manufacturer. By standardizing the information on COAs, this voluntary guideline will benefit both ingredient suppliers and dietary supplement manufacturers.

• Location: Meadowlands Expo Center – Room A
• Speaker: Michael McGuffin, president, American Herbal Products Association

This presentation will review obligations of marketers of dietary supplements when they receive adverse event reports (AERs) associated with their products. It will also discuss the process used by FDA to evaluate the AERs the agency receives, and will provide data on the numbers and types of AERs submitted to FDA on dietary supplements.

• Location: Meadowlands Expo Center – Room A
• Speakers: Marc Ullman, Esq., partner, Ullman, Shapiro & Ullman LLP; Anthony L. Young, Esq., partner, Kleinfeld, Kaplan and Becker LLP

Four years ago at Focus on the Future, beverages were the centerpiece of the conference. And beverages continue to be a growing natural foods segment. A number of startup beverage companies are now part of Pepsi and Coca Cola; energy beverages feed the market; and now shots are up and coming—what a party! In mid-December, FDA issued a draft guidance document entitled "Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients and Labeling for Beverages and Other Conventional Foods." Who invited this to the party? Attend this session to hear Anthony Young discuss the FDA's draft guidance for conventional foods, and how the guidance may be seeking to put the brakes on structure/function and ingredient content claims for beverages. Marc Ullman will discuss how FDA's December draft guidance affects dietary supplement beverages (oops, maybe you cannot say beverage), and how to address the FDA draft guidance. Important regulatory wisdom for those who are in these segments or who are contemplating entry into these segments will be provided.

• Location: Meadowlands Expo Center – Room A
• Speaker: John F. Gay, executive director and chief executive officer, Natural Products Association

The dietary supplement industry looked very good striking out Washington Senators McCain and Dorgan, whose legislation could have crippled the industry, but there are some heavy hitters like Energy & Commerce Committee Chairman Henry Waxman still waiting to take a swing at DSHEA. Also in the lineup is Congress' Government Accountability Office, which is conducting an investigation of the marketing of supplements. Come hear NPA executive director and CEO John Gay give a scouting report on the opposition. What are the issues, who are we likely to face, and when might they be stepping up to the plate?

• Location: Meadowlands Expo Center – Room A
• Speaker: Carl Reynolds, senior advisor, dietary supplement programs division, Center for Food Safety and Applied Nutrition, Food and Drug Administration

Attend this session to hear FDA’s senior advisor at CFSAN provide the latest update on the agency’s initiatives pertaining to good manufacturing practices (GMPs). Dietary supplement companies with 20 or more employees were mandated to comply with the FDA’s final rule on GMPs last June. Don’t miss this opportunity to hear firsthand what FDA has encountered as a result of this mandate.