Click the video below for information about our top-notch Nutrition I & II Education Tracks.
NUTRITION SCIENCE ADVISORY BOARD
Jon Benninger, Vice President, Business Development, Health & Nutrition Network, VIRGO Mark Blumenthal, Founder and Executive Director, American Botanical Council (ABC) Shane Durkee, Director, Global Medical Nutritionals and Innovation/New Technology, Bayer Consumer Care AG Guru Ramanathan, Ph.D., Senior Vice President, Scientific Affairs, General Nutrition Corp. (GNC) Daniel J. Stein, Principal Scientist, Bausch & Lomb
Sessions
Tuesday, October 11
10-10:50am
The Clinical Trial Advantage
In light of the current FDA and FTC crack-down on claims, and with the lack of clinical trial regulations...
In light of the current FDA and FTC crack-down on claims, and with the lack of clinical trial regulations on how to substantiate claims, how does a company design a clinical study to get past the barriers and market effectively? Attend to hear Dr. Evans address this concern. Shapiro will provide insight into the challenges companies are facing in order to make sure they have done all their homework when it comes to marketing products with claims, as well as which companies are being targeted and how to prevent and deal with FDA warning letters. And Todd will address how to maximize return on investment (ROI) of a clinical study and how companies use clinical studies to market products more effectively.
There is no longer such a thing as a product bound only for the domestic market. In order to maximize profits...
There is no longer such a thing as a product bound only for the domestic market. In order to maximize profits, a company must either market internationally themselves or license another company to take on international territories. Failure to plan for international product approval is a plan for failure. Off-the-shelf procedures and protocols to satisfy criteria required by one regulatory domain may actually preclude approval for marketing the product in another country. Conducting more studies than necessary to satisfy multiple regulatory domains may not only be an unnecessary and expensive duplication of effort, but it engenders the risk of producing conflicting results. A company can maximize its future marketing efforts only by exploring its options well in advance, and a comprehensive, international plan is needed. Successful transplantation of a product and claim from one regulatory venue to another requires planning in the early stages with the eventual goal in mind, as opposed to lurching from one requirement to another performing unnecessary tests and making commitments in one regulatory dossier that may hinder approval in another strategic market.
The Top 10 Issues Confronting the Global Supplement Industry and What Industry Should Be Doing about Them
Attend this session to hear an overview of the top 10 issues confronting the global supplement industry and...
Attend this session to hear an overview of the top 10 issues confronting the global supplement industry and what industry should be doing about these issues. Venardos will highlight the following: ensuring product quality—the struggle to achieve cGMPs (current good manufacturing practices), and addressing the 483s and warning letters; the IADSA global industry guidance; substantiating product claims in the United States and European Union; issues associated with FDA’s new dietary ingredient (NDI) guidance; post-marketing surveillance and signal analysis; the ongoing challenge of Prop 65; discrimination and protectionism as they impact international commerce in Mexico, Europe, Japan, Russia and Argentina; botanicals and herbs; self-regulation vs. federal agency enforcement; and an update on congressional dealings.
Location:
Congress Center, Murano 3301, Level 3
Speaker:
John P. Venardos, senior vice president, worldwide regulatory, government and industry affairs, Herbalife Ltd.
1-1:50pm
Working with Contract Manufacturers in Today’s Industry
ow does one evaluate, choose, monitor and work with contract manufacturers in today’s environment of GMP...
How does one evaluate, choose, monitor and work with contract manufacturers in today’s environment of GMP inspections, regulatory enforcement, economic adulteration and other factors? What happens to your company if your contract manufacturer fails a GMP inspection, receives an FDA Warning Letter or 483, or discovers an issue affecting your product or others made in their facility? How can you ensure your company is GMP compliant when you work with contract manufacturers? How does working with contract manufacturers impact any risks or exposure you might have? In this session, two industry leaders will discuss these critical issues to help you avoid the pitfalls and secure the benefits outsourcing all or some of your manufacturing can provide.
Joint Health Clinical Trials – How to Support Joint Health Claims without Arthritis
Joint health ranks among the top concerns of the aging baby boomers and represents an unmet need for this...
Joint health ranks among the top concerns of the aging baby boomers and represents an unmet need for this population. Most of the claims for joint health rely upon studies conducted on people with osteoarthritis using endpoints like the WOMAC. The Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA) have made it clear that diseased populations and disease endpoints in clinical trials are reserved for drugs. So how do you design, run and analyze studies for joint health that are compliant with these regulations? Dr. Udani will review the causes of joint discomfort and the underlying mechanisms of action. This will lay the groundwork for a detailed discussion on clinical trial design for joint health and joint function, which maximizes the effect of dietary supplements and remains compliant with changing global regulations.
Location:
Congress Center, Murano 3301, Level 3
Speaker:
Jay Udani, M.D., C.P.I., assistant clinical professor, UCLA School of Medicine; CEO and medical director, Medicus Research LLC; medical director, Northridge Hospital Integrative Medicine Program
3-3:50pm
Cardiovascular Disease Predictors and Biomarkers
The American Heart Association estimates nearly 81 million Americans have one or more types of cardiovascular...
The American Heart Association estimates nearly 81 million Americans have one or more types of cardiovascular disease (CVD). There are several historically-used measurements for identifying if an individual is at risk for developing CVD, including levels of LDL and HDL cholesterol, total cholesterol, high blood pressure, triglycerides and high-sensitivity C-reactive protein (hsCRP). However, there are other biomarkers, including oxidized LDL and the oxidized LDL/HDL cholesterol ratio, that are actually being shown in clinical research to be more sensitive indicators for discriminating between individuals with and without coronary artery disease than traditionally measured biomarkers. This presentation will review what defines a biological marker; types of biomarkers including natural history markers, drug activity markers and surrogate markers; why biomarkers are used; and select cardiovascular biomarkers and how they are indicators of arterial vulnerability. Attendees will walk away with a strong understanding of emerging cardiovascular biomarkers, the increasingly important role they play in identifying those at risk for cardiovascular disease, and the potential for using biomarkers to support product claims.
Finalizing FDA’s Operating Procedures for GRAS Determinations—Finally?!!
Administrative procedures presently governing FDA’s voluntary GRAS notification program date to the...
Administrative procedures presently governing FDA’s voluntary GRAS notification program date to the publication of the proposed rule in 1997, which has not yet been finalized. In early 2010, GAO published a detailed evaluation of FDA’s administration of the GRAS program, and was critical of the fact FDA had not issued final regulations by which the GRAS program was to be administered. FDA reopened the comment period to obtain updated feedback as an important step to be taken in finalizing the GRAS operating procedures. What feedback has been provided to FDA? What practices currently in place are expected to remain unchanged? What changes in GRAS operations are anticipated? Will confidentiality considerations be modified? Will the substantive treatment of notified substance identification or estimates of dietary consumption be altered? How will GRAS procedural changes impact the regulated food industry? A review and analysis of these and other issues will be discussed to enable ingredient suppliers and formulated food manufacturers to develop a “road map” to better navigate anticipated regulatory changes.
Product Endorsements: How to Legally use Testimonials and Endorsements to Market and Advertise Products
This session will start by defining consumer testimonials and expert endorsements, followed by a discussion of...
This session will start by defining consumer testimonials and expert endorsements, followed by a discussion of the recent increased focus by regulatory agencies, such as FDA and FTC, on testimonials and endorsements. The FTC Guides on the Use of Endorsements and Testimonials, with an emphasis on appropriate disclaimer and relative claims of achieved benefits and the specific content of testimonials, including recent warning letters from FDA that identify testimonials as including improper disease claims, will be addressed. This session will then shift focus to obligations of companies to properly monitor distributors, affiliate marketers, and other third-parties using testimonials to market the company’s products. Recent actions by FTC, including the April lawsuits against acai berry manufacturers, the March settlement with Legacy Learning Systems, and other FTC actions will be highlighted. This session will conclude with tips on how to successfully and legally use endorsements and testimonials in advertising.
EU legislation will have global impact on international business. EU legislation covers all areas of the natural...
EU legislation will have global impact on international business. EU legislation covers all areas of the natural products industry, from food supplements, functional foods, herbals, botanicals and health claims. Marketing products in a changing legal environment has its complexities as well as opportunities, and getting the latest update is important to know how to maximize those opportunities. What is happening in Europe is being closely watched by authorities across the globe, including the United States, and will impact your business from source to store. Last is the chairman of the leading UK trade association, the Health Food Manufacturers Association, which is at the heart of helping to defend our industry and fight for workable, appropriate legislation with the authorities in the UK and EU. Hear about the latest campaigns to help protect your interests in Europe and how to make your voice heard in the process.
Location:
Congress Center, Murano 3301, Level 3
Speaker:
Martin Last, chairman, Health Food Manufacturers Association; founder, MPL Marketing Services Ltd.
Noon-12:50pm
Dietary Supplement cGMPs: One Year after Full Compliance—What have We Learned?
It’s clear from audit reports and the number of warning letters that the dietary supplement industry is still...
It’s clear from audit reports and the number of warning letters that the dietary supplement industry is still struggling with how to comply with cGMPs (current good manufacturing practices). Do we really have a good understanding of the final rule? Does one size fit all companies? In this session, we will review the top five problem areas: Quality personnel responsibilities, raw material vendor qualification, master manufacturing records and testing of raw materials and finished products with an emphasis on suggested ways to become compliant regardless of company size. One size does not fit all; there are different ways to achieve the same goal.
Location:
Congress Center, Murano 3301, Level 3
Speaker:
Joy A. Joseph, president and founder, Joys Quality Management Systems
Thursday, October 13
9-9:50am
FDA Update on GMP Inspections
Hear firsthand from FDA about the current state of industry’s cGMP compliance based on a growing number of...
Hear firsthand from FDA about the current state of industry’s cGMP compliance based on a growing number of FDA inspections, 483s and warning letters. What areas seem to be the most problematic for industry? Is the situation improving? Learn from the experiences of others to help ensure your FDA cGMP inspection goes well.
Location:
Congress Center, Murano 3301, Level 3
Speakers:
Bradford W. Williams, manager, Division of Dietary Supplement Programs, Food and Drug Administration (FDA)
10-10:50am
Yes, the Industry is Watching Your Advertising!
If your dietary supplement advertising crosses the “legal” line, yes there is someone watching! In addition...
If your dietary supplement advertising crosses the “legal” line, yes there is someone watching! In addition to FTC and FDA, the two largest dietary supplement trade associations each have voluntary programs that review advertising for these products and “police” outrageous, misleading or illegal claims. The Council for Responsible Nutrition (CRN) is in the fifth year of its program with the National Advertising Division that has reviewed over 100 ads and produced written decisions on the accuracy of these claims. The Natural Products Foundation maintains its own Truth in Advertising program, alerting companies that make drug-like claims for their supplement products and referring noncompliant cases to FTC and FDA for their own investigation. Come hear the heads of these associations discuss their efforts to self-police the industry and improve consumer confidence in supplement ads. Find out what kinds of claims are likely to draw their attention, how to avoid these advertising pitfalls, and what has happened to some of these cases. Learn why some firms cooperate with these programs and what has happened to others who thumbed their noses at voluntary programs—at their own peril!
Location:
Congress Center, Murano 3301, Level 3
Speakers:
John F. Gay, executive director and CEO, Natural Products Association Steven Mister, Esq., president and CEO, Council for Responsible Nutrition
11-11:50am
Warning Letters, cGMPS and Recalls—Trending Upward
Over the last year, FDA has sent numerous warning letters to dietary supplement manufacturers, and more...
Over the last year, FDA has sent numerous warning letters to dietary supplement manufacturers, and more of them address serious cGMP (current good manufacturing practice) deficiencies. GMP violations at over-the-counter (OTC) drug manufacturers are up as well, and one of the largest, McNeil – PPC, a division of Johnson & Johnson, is now operating under an FDA consent decree. Recalls of OTC drugs and other products manufactured by McNeil have filled the news over the past year and a half. At the same time, dietary supplement recalls associated with salmonella contamination appear more frequently. Attend this session for a discussion of how these events impact the dietary supplement industry and what companies can do to protect their franchises.
