SupplySide

NUTRITION SCIENCE ADVISORY BOARD

SESSIONS

• Location: Congress Center, Casanova 601, Level 1
• Speaker: George M. Pontiakos, president and CEO, BI Nutraceuticals / Zuellig Group N.A.

Contamination and adulteration of products continues to be the premiere issue plaguing the natural products industry as a whole. When price becomes the foremost concern for a manufacturer, above the safety and quality of the material, suppliers are encouraged to adulterate in order to meet pricing targets. This session will highlight recent high-profile cases of adulteration, discuss the impact of those cases on the industry as a whole and provide attendees with valuable information on how they can avoid a similar fate. Topics to be covered include techniques for proper species identification of materials; defined processes for traceability to ensure raw materials are compliant to specification, unadulterated and free of harmful residual pesticides or toxic chemicals; the liability of adulteration for the supplier and the customer; what companies should do to protect their products and their reputation, such as partnering with suppliers that practice GMPs and have established testing and traceability programs; and how to effectively work with the industry’s regulatory agencies.

• Location: Congress Center, Casanova 601, Level 1
• Speaker: George A. Burdock, Ph.D., president, Burdock Group

FDA has been very clear in its intention to fully prosecute its mandate to protect consumers from mislabeled and unsafe products and fraudulent claims. A focal point of the agency’s attention has been on claims and the lack of support and/or inappropriateness of the claim for the category of product, even as the lines separating drugs, foods and supplements continue to blur. During this session, Dr. Burdock will illustrate the regulatory divisions between product categories and how minor changes in the language of the labeling describing the product, can cause a product to change categories (such as from a food to a drug). FDA regards these categories as having a high level of organization and separated by precise boundaries, and considers deviations from the prescribed limits as violative actions with products subject to seizure and, under the Responsible Corporate Officer doctrine, the corporate officers are exposed to possible civil and criminal penalties. FDA’s position is that if manufacturers wish to market a regulated product, they must acquaint themselves with the regulations. Dr. Burdock will provide a step-by-step tutorial on how to distinguish one category from another and the regulatory and safety requirements, and allowed claims for each. This lecture is a “must see” for anyone involved in regulations, product labeling or claims.

• Location: Congress Center, Casanova 601, Level 1
• Speakers: Darryl Sullivan, immediate past president, AOAC Intl.; director of scientific affairs – analytical chemistry, Covance Laboratories; Barry Titlow, CEO, Compound Solutions Inc.

In response to the dietary supplement good manufacturing practice (GMP) regulations from FDA, there have been a number of new techniques developed for ID testing of dietary supplement ingredients. These methods have involved chemical, chromatographic, IR, UV, MS and NMR techniques. Many of these methods are currently being used in laboratories without adequate validation or standardization. The key components of method validation will be discussed along with suggestions on what should be done in the laboratory in order to standardize some of these tests. AOAC International has initiated a program to help analysts understand the components that are required for validating an ID method. This program will be presented as a useful tool for understanding the principals of full validation for an ID method. Since important decisions are being made based on the results of these ID tests, it is important that we understand their limitations and how we can evaluate these through adequate laboratory validation and standardization. Another factor to consider is the cost of ease of use of an ID method. A balanced approach to good science, cost effectiveness, specificity and ease of use is recommended.

• Location: Congress Center, Casanova 601, Level 1
• Moderator: Mark C. Roman, Ph.D., president, Tampa Bay Analytical Research Inc.
• Speakers: Paula N. Brown, M.Sc., director, Integrative Bioscience Research Cluster, British Columbia Institute of Technology; James Harnly, Ph.D., research chemist, U.S. Department of Agriculture

One of the key provisions of the dietary supplement good manufacturing practice (GMP) regulations promulgated by FDA in 2007 is the requirement to perform 100-percent identity testing of dietary ingredients. There are a number of approaches to identity determination already in use, including microscopic evaluation and thin-layer chromatography, but new technologies are constantly being developed. Advances have been made in DNA fingerprinting as well as chemical fingerprinting of plants over the past several years. Other approaches include FTIR, UV-visible spectrophotometry (UV-Vis), LC/MS and NMR. An attractive feature of the newer methods is the ease with which they can be interfaced with advanced statistical techniques and pattern-recognition software. This capacity should make validation of the new identity methods much easier.

• Location: Congress Center, Casanova 601, Level 1
• Moderator: Leila G. Saldanha, Ph.D., R.D., scientific consultant, Office of Dietary Supplements, National Institutes of Health
• Speakers: Robin J. Marles, Ph.D., director, bureau of clinical trials and health sciences, Health Canada; Bradford Williams, manager, Division of Dietary Supplement Programs, Food and Drug Administration

Assuring that a dietary supplement or ingredient does not present a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or under ordinary conditions of use can be challenging. Data collection and a transparent expert evaluation process are keys to assuring consumer safety. Dr. Robin Marles of Health Canada’s Natural Health Product Directorate will present an overview of the safety evaluation process developed and utilized by the United States Pharmacopeia’s Expert Committee-Dietary Supplements during the USP’s 2005-2010 revision cycle. The second part of the safety equation is embodied in the dietary supplement GMP. FDA's Brad Williams will provide an overview of the GMP provisions most pertinent to safety and provide suggestions on implementing those provisions within your facility.

• Location: Congress Center, Casanova 601, Level 1
• Speakers: Mike Bradley, director scientific affairs – nutrition, Perrigo Co. of South Carolina; Anthony Palmieri, marketing segment head – infant nutrition and medical foods – human nutrition and health North America, DSM Nutritional Products Inc.; Harry B. Rice, Ph.D., director of regulatory and scientific affairs, Untied Natural Products Alliance

For both dietary supplement manufacturers and ingredient suppliers, the supplier qualification process is costly, complex and not well defined in the GMP regulation. Proper supplier qualification is also necessary to help manufacturers trace their products’ lineage through the supply chain, a requirement in proposed food safety legislation. However, the absence of formal and detailed guidance from FDA on supplier qualification leaves the industry and the agency vulnerable. Due to resource limitations, a risk-based approach is the only feasible way to properly qualify suppliers. Thus, the industry’s five trade groups through the Joint SIDI Working Group have set out to develop a voluntary supplier qualification guideline. Some of the most critical aspects of a supplier qualification program include assessing the supplier’s change management, documentation and recordkeeping, certificates of analysis, GMP compliance, and more. The Joint SIDI Working Group is in the process of developing a broad voluntary guideline that encompasses these aspects and which dietary supplement manufacturers can use to help develop their own supplier qualification programs. This session will provide attendees with a broad understanding of the requirements for and important aspects of supplier qualification, the importance of taking a proactive approach to develop “best practices” standards and up-to-date progress made by the Working Group.

• Location: Congress Center, Casanova 601, Level 1
• Speaker: Steven French, managing partner, Natural Marketing Institute

Consumers are changing many long-held societal norms, and this behavior opens the door to disruptive innovation. They are breaking the mold, “just saying no” and balking at tradition – creating entirely new market sectors for health and wellness products. Join NMI trend expert Steve French as he presents this disruptive perspective for marketers of health, wellness and sustainability with a sneak preview of brand new consumer data. Four main trends will be explored: (1) Personal ROI: Consumers are demanding greater value from every product or service they buy, stemming from the desire to make the most of everything we have, including the investment of time and money; (2) Pure & Simple: New trends in purity and simplicity are evident as we move to simpler inputs, focused messaging, cleaner labeling, streamlined design and easy delivery. This “less is more” trend is resonating with values-driven consumers, natural and eco-friendly enthusiasts and convenience shoppers – purity and simplicity is now the ultimate sophistication; (3) Meaningful Green: GREEN has penetrated the consciousness and purchasing behavior of consumers across the globe with almost every company and product claiming at least a small place at the sustainability table - the challenge now is in achieving meaningful differentiation, as GREEN initiatives must be distinctive, memorable and measurable if they are to impact environmental, social and economic dimensions; and (4) Health Care Revolution: New economic realities are motivating many to take greater steps towards proactive Health Care rather than Sick Care and greater responsibility for their own health and wellness.

• Location: Congress Center, Casanova 601, Level 1
• Speaker: David Sprinkle, research director, Packaged Facts

With health and wellness established as a top driver for consumer choices, and with the nutritional industry poised for growth as the economic downturn of 2008/09 recedes, this discussion examines key trends in consumer preferences for supplements, fortified food and beverages, and specialty formats such as energy shots and beauty drinks. This session will draw on consumer surveys, retail sales-tracking data, new product introduction statistics and analysis of social media streams to discuss best-selling products across the competitive landscape and current pathways/obstacles to nutritional product success.

• Location: Congress Center, Casanova 601, Level 1
• Speakers: James R. Coughlin, Ph.D., president, Coughlin & Associates; Peg Carew Toledo, Esq., partner, Mennemeier, Glassman & Stroud LLP

California passed a law titled The Safe Drinking Water and Toxic Enforcement Act of 1986, commonly referred to as “Proposition 65.” Foods and dietary supplements are known to contain numerous listed Prop 65 chemicals, and it is the obligation of manufacturers and sellers of these products to assess whether their products comply with Prop 65’s legal and regulatory requirements. Foods and dietary supplements have been one of the major targets of Prop 65 enforcement activities in the last several years. For example, there has been litigation involving lead in dietary supplements; acrylamide in French fries, potato chips and cereal; and mercury in fish. Indeed, in the last two years, California plaintiffs have initiated over 230 Prop 65 cases involving dietary supplements and foods. This presentation will discuss the current state of the scientific, regulatory and legal issues surrounding foods/beverages, functional foods and dietary supplements under Prop 65. It will provide sufficient background on Prop 65 such that the presentation will be interesting and informative to both the Prop 65 novice and those who have significant experience dealing with Prop 65 issues.

• Location: Congress Center, Casanova 601, Level 1
• Speakers: Rick Kingston, PharmD, president, regulatory and scientific affairs and senior clinical toxicologist, SafetyCall Intl. PLLC, and clinical professor of pharmacy, University of Minnesota; Garry Pay, Esq., vice president and assistant general counsel, Twinlab Corp., an IdeaSphere Co.

Every supplement manufacturer receives allegations of expected or unexpected side effects or adverse events potentially caused by the use of their products. Some of these incidents may compel a consumer to seek compensation for medical reimbursement and possibly monetary awards for pain and suffering. Aside from meeting mandatory regulatory reporting requirements, how does the manufacturer evaluate these incidents and any allegations of injury to determine options aimed at successful resolution with the consumer and ultimately manage and prevent product liability related litigation? This session is designed to provide a roadmap for the supplement manufacturer in dealing with these issues, addressing consumer and regulator concerns and expectations, and prevent unnecessary damage to the company and the brand.

• Location: Congress Center, Casanova 601, Level 1
• Speaker: Travis T. Tygart, CEO, U.S. Anti-Doping Agency

In this session, Travis Tygart, CEO of the U.S. Anti-Doping Agency (USADA), discusses his organization’s efforts to ensure drug-free competition in sports, including his organization’s concerns with dietary supplements. USADA works with the Olympics, Major League Baseball, the National Football League and most other sports organizations, and recently launched the “Supplement Safety Now” campaign seeking changes to the way dietary supplements are regulated. In addition to USADA’s concerns, Tygart will discuss the current state of doping in sports and how the dietary supplement industry and anti-doping agencies can work collaboratively to protect the health of all athletes and the integrity of America’s playing fields.