The CRN (Council for Responsible Nutrition) 2004 Annual Conference on Dietary Supplements, held October 24-27, just outside of Washington, DC, has to be considered a success.
With almost 140 registered attendees, active participation and coverage of both domestic and international issues and a keynote speaker (Dr. Lester Crawford, D.V.M., Ph.D., Food and Drug Administration Acting Commissioner) who delivered a message industry has been waiting ten years to hear, the stage was set. But more than an industry and issue event, this gathering was a tribute, a send-off to a universally respected individual whose contributions to the association as well as to industry have been immense, and it was only fitting that in her last annual conference before retiring as CRN President, Dr. Annette Dickinson should introduce a new relationship with the Food and Drug Administration (FDA), but also new policies and new leaders.
First the Program:
An opening reception at the National Air and SpaceMuseum's StevenF.Udvar-HazyCenter followed the event golf tournament. The presence of FDA's Dr. Barbara Schneeman (Director of the Center for Food Safety and Applied Nutrition’s (CFSAN) Office of Nutritional Products, Labeling, and Dietary Supplements) at the reception was perhaps an indicator of FDA's intention to engage industry at every opportunity.
The CRN members meeting included an overview of current regulatory challenges and CRN activities, including the defeat of California SB 779, which if it had passed, would have set up an adverse event reporting (AER) system that would have been untenable for the industry. The drive and need to establish a mandatory serious AER system at the federal level was noted as were internal association endeavors to both build and measure trust and credibility including the latest results of the CRN Consumer Confidence Survey and ongoing product stewardship efforts. The banning of ephedra and the signing of Bill S. 2195 to restrict anabolic steroids were identified as industry milestones and the monitoring of global regulatory developments was re-emphasized.
In the State of the industry address by Annette Dickinson, CRN President and Byron Johnson, Chairman, CRN Board of Directors, the significance of FDA's ban on ephedra was noted. In this action, FDA used the powers it possessed under DSHEA to ban the product, proving that the law, if enforced, worked. This notion would prove to be key for when FDA representatives presented a bit later.
The significance of the legislation restricting anabolic steroids was also noted, since these products, and the companies producing and promoting them, were removed from the industry. Commenting on enforcement action, the presenters noted the focus on New Dietary Ingredients (NDI's) and the scheduled FDA meeting to discuss New Dietary Ingredient notifications would set the stage for ongoing enforcement action. The releasing of a final GMP rule would establish an opportunity for industry to leverage its abiding by such a rule, creating a boost in consumer confidence and easier identification of what were termed "industry renegades".
Concluding, Dickinson and Johnson noted the goal to make supplements " the accepted healthy lifestyle choice".
By far the highlight of Day 1's program was the presentation entitled "DSHEA: Ten Years Later - FDA's Perspective", by Lester D. Crawford, D.V.M., Ph.D., Food and Drug Administration Acting Commissioner. In his address, Dr. Crawford outlined the agency's current priorities and objectives, identifying supplement GMP's and enforcement activities as critical. Most importantly, he stated, in a view that was later echoed by other FDA staff, the commitment to "demystify the process", "operate with transparency, consistency and predictability" and to satisfy the intent of DSHEA legislation by full implementation.
Later in the first day, Dr. Robert Brackett (Director, FDA's Center for Food Safety and Applied Nutrition) and Dr. Susan Walker (Director, Division of Dietary Supplement Programs, Office of Nutritional Products, Labeling, and Dietary Supplements further outlined FDA's activities and priorities.
Two afternoon concurrent sessions dealt with 1) The Benefits and Risks of Sports Nutrition Supplementation and 2) The Growing role of the Office of Dietary Supplements (ODS).
The first session was presented by Dr. Ron Maughan, visiting professor in the School of Sport & Exercise Sciences at Loughborough University in Leicestershire in the UK, a fellow of the American College of Sports Medicine and secretary of the Sports Nutrition Group established by the International Olympic Committee Medical Commission. Dr. Maughan spoke about the role of nutrtional supplementation in sports, noting that performance benefits were small, if any, and that certain categories, especially those related to immune and recovery were likely of the most interest. He recommended a breakdown of supplements and supplement use by functional category, additional policing (by industry and the sports community) and an expanded research and educational effort.
Day 2 began with "Inside Washington, and a Special Report from California", providing attendees an update on current legislative issues, concerns and activities. Jay Hawkins from lobbyist, The Alpine Group, noted that the dust from the election might take weeks to settle, the House will likely be aggressive with legislation, and new legislators in Washington will need to be quickly reached with the industry's message. From California, Randy Pollock from Livingston & Mattesich commented on the recently defeated AER bill (expected to be re-presented in some form next year) and also noted the high turnover of representatives creating both opportunities and challenges for the industry.
Next up was a presentation by Bart Moore from Atlantic Media entitled ,"Where Appearance is Everything, Lessons on Strategic Public Image Management" including knowing the audience and how they form their opinions and the fact that an image can be managed proactively.
Dr. Phil Waddington, Director General, Natural Health Products Directorate, Health Canada presented next, describing the Canadian regulatory model including pre-market approval and enforcement priorities.
The afternoon concluded with a panel discussion entitled, "Creating Momentum for Self-Regulation of Claims".
The concluding day of the event began with "Building Bridges, forging alliances", with several speakers from outside the industry describing information needs and perspectives as well as future communication opportunities. Speakers in this panel discussion included Mary Ann Johnson, (University of Georgia), Marilyn Speedie (University of Minnesota) and David Schardt (Center for Science in the Public Interest).
Dr. Johnson spoke of the perspectives and perceptions among the medical community dealing with various demographics, encouraging industry to expand its dialogue and relationships with groups such as the American Academy of Pediatrics and those involved in Gerontology, and to work with thse groups to develop evidence-based information resources and ongoing communication regarding the benfits of supplementation, measured against specific end-points. She suggested that this ongoing dilaogue include presentations at conferences, workshops and other collaborative opportunities.
Dr. Speedie spoke about the College of Pharmacy perspective, also calling for openness and education of The Pharmacist community, and noting the University of Minnesota's desire to be involved in Adverse Event Reporting mechanisms for dietary supplements through Dr. Rick Kingston's Center for Dietary Supplement Safety.
David Schardt's presentation was of a slightly different nature, although he too urged dialogue. He noted CSPI's support for multi-vitamins, omega-3's, phytosterols, glucosamine, chondroitin and saw palmetto, and observed that there are efficacy and quality concerns, as well as 'safety issues' that prevent more vocal support. Schardt noted herb-drug interactions and inadequate infromation for consumers regarding product safety and urged industry to work with independent organizations (he suggested the Insititue of Medicine) to review product efficacy, and to aggressively undertake interaction research.
The General sessions then concluded with "Doing Business Internationally: It Takes More Than a Village", which included presentations by F. Edward Scarbrough, USDA's U.S. Manager for Codex, Sindy Straessen, EU Policy Taskforce, CRN UK and Herbalife International describing the complex EU regulatory environment and some of its implications, and Mark Mansour, Morgan Lewis Counselors at Law.
An excellent networking venue was combined with breaking information and the chance, through interaction, to put the message into context. Several rather full days allowed participants to cover most relevant industry issues in a good facility, close to Washington, a fact which led to excellent participation from Washington and was good for travel.
Certainly an event highlight was the dinner and Magic show. Jason Randall 'wowed' the crowd in a phonomenal magic performance that included solid entertainment, good spirited 'ribbing' and tricks that left participants buzzing for days afterwards. And as the show unfolded, so too did the tribute and appreciation for CRN's departing President, Annette Dickinson.The CRN staff, board and membership all applauded Dickinson's efforts, style and achievements in an appropriate send-off.
The 130+ attendees represented CRN member companies and other interested participants. Suppliers, finished products companies and service providers were all represented, and among the finished product companies, most distribution channels were present including direct, practitioner and mass/natural channels.
The over-riding message included the optimism of more positive relationships with regulators, a more proactive agenda with legislators, and as importantly, as she prepared to retire, gave testimony to CRN President Annette Dickinson's efforts over the past 31 years and the credibility and respect she and CRN have obtained in that time, from regulators, legislators, media, CRN members and the industry. Also part of the take-home message was the fact that the next CRN President might need different skills and capabilities, would need to rely heavily on CRN's acumulated expertise, and would lead a very credible organization - but would have a daunting task ahead.