By Len Monheit
This year’s CRN Annual Conference on dietary supplements was an interesting event from a number of perspectives from the production and execution of the event itself, to the networking and information gathering opportunities that it presented.
Although overall attendance at this event may have declined a bit over recent years, for Council for Responsible Nutrition (CRN) members and other regulars, this event, held this year in Scottsdale, Arizona, provided an opportunity to interact, in some cases, the only public opportunity, with movers and legends, as well as a top notch slate of presenters including riveting keynotes. The social calendar was also quite active, this year featuring a games night (CRN zone), a ‘Ranch Roundup’ and a Casino Royale evening, with all the accoutrements one would expect each of these to offer.
Let’s get into the substance of the event itself and some of the messaging delivered.
The first day of presentations began with a well-choreographed member meeting and business session, providing a perspective on industry issues and consumer’s behaviors, as well as CRN-involved initiatives such as SIDI, the Life…Supplemented PR campaign and the NAD ad review program (all would be dealt with in more detail later in the program)
The take home messaging, at least to me, was the importance of building bridges of trust (with practitioners, consumers, and along the value chain) and judging by the very frequency with which the word was used, a new focus for CRN in reaching and impacting consumers.
The first keynote was delivered by Robert Brackett, Director, Center for Food Safety and Applied Nutrition, FDA, presenting FDA perspectives and realities (including headcount and budget decline) and the agency approach to decision making and prioritization including focus on food defense and safety, improving nutrition, as well as supplement and cosmetic safety, leading to activities such as education and the development of nutritional ‘symbol’ systems. Specifically in the supplement realm, priorities include contaminants (especially drug ingredients, metals such as lead, and pesticides) with the agency intending to do more ingredient and finished product sampling and possibly devoting more resources on already identified problems and issues. These would include New Dietary Ingredients (NDIs), many of which are currently used without the required notification (possible guidance document to be expected in 2008) and a focus at the food-dietary supplement boundary, especially beverages. (Dr. Brackett noted that the law (DSHEA) was not intended to cover the practice of placing conventional-like products in the dietary supplement realm) and indicated that the agency would further explore this as a policy and safety issue. A further agency priority would be the use of illegal disease claims in the marketing of supplements.
As far as GMPs were concerned, Dr. Brackett noted that training of inspectors would certainly be required, hinting that industry help might be solicited and appreciated , confirming the obvious – that a lot of work was yet required, as well as huge additional resources. From an enforcement perspective, he noted that the agency would rely primarily on voluntary corrections but that the agency would focus on a few ‘big splash’ examples, and even consider legal options such as criminal prosecution.
Brackett went on to describe a projected reorganization of the FDA into several offices to make more efficient the use of some resources including analytical and electronic, and making changes to consolidate like and related functions such as compliance and enforcement. (and all food safety into one office.)
In all, while the presentation was not paradigm shaking, it was informative and somewhat useful.
The afternoon session for the first day dealt with more detail on the Standardized Information on Dietary Ingredients (SIDI) protocol, which CRN and other associations are trying to assist gain in use and popularity, the NAD (National Advertising Division of the Council of Better Business Bureau’s) advertising self-regulatory initiative which has now questioned some 20 advertisements and a series of scientific presentations covering botanicals, enzymes and carotenoids.
The Day 2 keynote address was high-energy, interactive and entertaining. Paul Stoltz, co-author of ‘The Adversity Advantage’ spoke about the issue of adversity and individual behaviors associated with confronting it. Attendees not only gained insight into their own triggers and responses, but also had the opportunity to pelt John Venardos with colored ‘nerf’ balls, truly one of the highlights of the conference.
The next session on Day 2 involved presentation, in some detail, of CRN’s Life…supplemented PR campaign and its objectives, a program which, according to the presenters, was “not science based, but based on science,” with an overall objective to increase mainstream consumption of supplements. The program includes a personal Wellness Scorecard, available on the website at www.lifesupplemented.org, and ultimately will include web advertising and viral communication initiatives and site sponsorships in the hope of increasing awareness – and ultimately supplement consumption. The program (ultimately a minimum of three years all told) also includes a survey on practitioner supplement use and in all has been underwritten thus far to the tune of over one million dollars.
When challenged in Q and A regarding possible similarities and overlap with other industry initiatives (specifically DSEA), the response was that ‘supporters will vote with their pocketbooks’ and that it’s acceptable that industry is not speaking with one voice, so long as everyone is saying the same thing. It was also noted that PR (which is the core part of this program) is not the same as advertising (the key part of ongoing DSEA activities). Personal note – Several years ago, DSEA started with a major initiative that definitely included PR. To my knowledge the objectives (PR anyway) were never fulfilled. Perhaps CRN will fare better. As far as interacting with and surveying practitioner supplement use, I think those findings might be quite useful. The key metric here though will be developing tactics to influence practitioner supplement use, and ultimately translate this use (existing and future) into an ongoing dialogue and exchange of information.
The day’s sessions went on to include a discussion of international issues including science and Policy for Maximums for Nutrients in supplements and a presentation by Basil Mathioudakis, of the Health and Consumer Protection Directorate, General European Commission, dealing with EU Directives and Codex Guidelines involving food supplements. For CRN to invite and engage such a senior EU regulator is significant, and to have him participate and contribute throughout the entire conference is noteworthy.
The final day began with another keynote presentation, ‘Breakfast with… Dr. David Katz’ (www.davidkatzmd.com) , featuring Dr. Katz, board certified in Internal Medicine, director of the Yale Prevention Research Center, nutrition columnist to O, The Oprah Magazine, and Medical Contributor for ABC News among other highlights and achievements.
My general thoughts - First of all, I have never before attended a presentation with as many resonating sound bites. Secondly, interacting with high profile practitioners like this has got to be an industry focus. Thirdly, despite his apparent knowledge of both the state of science and the principles of integrative medicine, Dr. Katz, in Q and A admitted that his primary source for determining which products were ‘better than others’, was Consumerlab.com. Obviously industry has much work to do in assisting key influencers if this is the only way they can determine which products to buy. Also obviously, a certain pall came over the audience when this was mentioned, given CRN’s history with Consumerlab.com.
Back to the presentation - Dr. Katz noted that regarding most products, “epidemiology equivocates” noting specifically Vitamin A, which has both positive and negative attributions (the vaccine for measles doesn’t work in individuals with low levels of Vitamin A) and folic acid which is strongly supported by its ability to decrease the incidence of neural tube defects, but poses a challenge since supplementing with it might mask Vitamin B12 deficiency. Dr. Katz spoke specifically about chromium and the rising incidence of diabetes, and the emerging linkage between diabetes and cardiovascular disease, wondering whether, as the incidence of diabetes in children continues to rise, whether there soon will be more incidence of CVD in children as well.
Regarding the call for science to support the use of supplements, Dr. Katz noted that sometimes you cannot conclude, you must make a leap of faith. “The lack of science is not evidence of absence”, he noted. He went on to observe the connection between the evolution of dietary patterns and nutrient profiles, talking about the ratio of omega-3 fatty acids to omega-6 fatty acids, the loss of Vitamin E from diets over generations meaning that we could be under-supplementing currently (and are definitely under-consuming), discussing what it really means to be a 21st century hunter-gatherer and the ideal nutritional profile, leading predictably to a few remarks about nutrigenomics. “A lot of what we know in life comes from observational data and common sense, but we do need a science-based model to answer the challenges.” Katz observed. “Human need goes on after the science runs out.” Inevitably, according to Katz, in real life, we need to move away from the evidence, “yet we train practitioners to only use Randomized Clinical Trials. There’s a tyranny of evidence in modern medicine”, he concluded, “Evidence is a tool in your toolkit, not the bars of the cage.” “For that matter, even with a gold standard clinical trial – is it relevant on an individual basis”, he challenged.
Dr. Katz fielded a few interesting questions. One involved his own personal supplement use and whether he was consistent in the guidance he offered to his patients with Katz answering affirmative. When questioned regarding how he made his personal decisions on brands, as noted earlier, he referred to Consumerlab.com as his guidance in this area, much to the chagrin of those in the audience.
The final day’s program went on to include a discussion of quality in the global supply chain with a focus on China including some of the forces at work leading to a general focus of conformity over quality, and the formal conference concluded with an industry leaders’ forum.
In summary, some personal takeaways and observations:
- Definitely a worthwhile, well-organized event
- Keynote speakers were excellent and thought provoking from both a personal and professional standpoint.
- My AQ (Adversity Quotient) is above average
- We’ve received confirmation that FDA will enforce the GMPs at least in part, by a couple of carefully selected, high profile enforcement actions
- We need to engage more practitioners like Dr. David Katz
- Despite past efforts that have been less than successful, CRN is initiating a PR campaign to promote supplement use. One hopes that this effort delivers better results than previous attempts. I can’t help wondering though – Is that the best use of millions of industry dollars?
- Anything is possible in the CRN golf tournament