By Len Monheit
By most accounts, Natural Products Expo West last week in Anaheim was an excellent event. The buzz on the floor was positive, the business environment seemed good, a few people observed less than an anticipated number of retailers, but most that I spoke with accomplished their business objectives, whether on the natural foods side of the show, or even on the SupplyExpo show floor, which for some, was a first time success. I think, for most, it was evident that SupplyExpo itself has arrived as a legitimate event - at least for the first two days, Friday and Saturday.
My overall impression of the show floor, especially on the supplements aisles, was of a growing maturity and professionalism - the environment seemed much less like a flea market, where you could buy just about anything for a buck, and more like a polished industry, struggling to present competitive advantage.
On the issues and trends side, I'm struck both by level of awareness, and at the same time, lack of awareness. Sounds contradictory, doesn't it? Let me explain. Let's start with the regulatory priorities.
GMP's are 'imminent'. I've heard anything from 45 days to six months, this time "guaranteed". I'm not sure this year, whether the fact translated to anything different in show floor behavior. Behind the scenes a few companies have taken steps to severely trump any GMP requirements (and in fact, have been doing so for years), while others know that quite quickly industry standard lingo will state 'GMP approved', 'GMP manufactured', without any meaning (or any legality) to the terms, and that GMP becomes an endpoint and not the beginning it could potentially be, and as I believe it must be. And we all know that unless something changes drastically with the FDA, enforcement of GMP’s will be a joke. This means that it is industry’s responsibility to determine just what quality assurance really will stand for. Otherwise, not only will a huge opportunity be lost, but GMP itself will be reduced to 'Great Marketing Program'.
Now let’s switch the focus to another pressing industry dialogue - New Dietary Ingredients (NDI’s). The comment period over, according to Dr. Susan Walker of the FDA, enough responses and comments were received by FDA to crash the server.
Well, at least we know the interest in NDI’s is there and this issue has made the corporate agenda.
What does it all mean?
According, again, to Dr. Walker, the intention of the questions FDA asked and responses it received was not to generate a guidance document or to engage the 'rule-making' process. So what other possible outcomes could there be? Well, possibly this is for clarification on what types of enforcement would be high priority and obvious, while others would be more contested and ambiguous. (That would be a good thing). Possibly it would be to establish clarity in definitions. (That too would be good thing, but a lofty ideal.) Possibly the intention would be to establish a long term dialogue with industry that would lead to process definition and collaboration to reduce squandering of resources so that more NDI submissions, in a relative sense, would be accepted. (also a good thing). Possibly, it is to raise the issue to top of mind for industry companies that are knowingly not in compliance with the current NDI requirements. Yes, there are ambiguities, and it is uncertain what the final decision will be on changes to 'old dietary ingredients' that make them new ones, and so several cases are currently right up in the air.
We’re now seeing at least three types of industry behavior. The first group is trying to understand the evolution of the NDI process and gauge what FDA is really looking for and moving their submissions in that direction. The second group is aware they are not in compliance, whatever the interpretation, and is doing one of two things, frantically building their safety dossier, so that they can say something like 'well now that you ask us for it, here it is', with the other half of the knowingly non-compliant ducking the radar in a ‘business as usual’ approach. The final behavior is the 'agency will decide' stance. These companies believe they have an argument to be compliant (whether believing they are grandfathered as an 'old ingredient', 'an equivalent product received no objections', the product was in the food supply, etc.) In this environment, they have determined that now is not the time to put through a submission or to challenge the interpretation. The net outcome of most of these behaviors is sort of 'wait and see', but one must ask, "wait and see what?" I think most in the industry acknowledge that many products in the industry cannot be justified by any interpretation of the NDI-related regulations.
This leads to the question of enforcement, prompted by an interesting comment that Marc Ullman from the law firm, Ullman, Shapiro & Ullman made at his NDI presentation to the AHPA (American Herbal Products Association) members meeting last Thursday.
To paraphrase, Mr. Ullman was suggesting that as FDA was looking for manufacturing process information at increasing levels in NDI submissions, in order to satisfy itself that the product would reasonably be expected to be safe, an opportunity was created, if the NDI process were actively enforced by the FDA. Ullman went on to argue that if the complete manufacturing process information was submitted, and the information submitted was the basis for FDA having no objections, and if companies stipulated that this information was confidential and it was redacted, then, only a specific manufacturing process could therefore produce the NDI to which FDA had 'no objections', therefore granting that product an Intellectual Property related proprietary position in the marketplace, which would theoretically deter unscrupulous competition from using the NDI of the original supplier as the basis for promoting their own products. It's an interesting argument, a positive step to justify investment not only in manufacturing processes but also in the cost of compliance. Unfortunately, the argument and possibility hinges on FDA enforcement - uncertain at best.
Another point raised at the same meeting was the benefits of pre-submission meetings and dialogue with the FDA.
Switching gears to other observations, with the launch of the Flax Lignan Information Bureau, (http://www.flaxlignaninfo.com/) another commitment to retail and consumer education commenced. In this case, funded by Acatris, the resource has been constructed to provide information about flax lignans and the emerging science to support the use of these products.
In general, at Expo as a whole, ingredient supplier presentations, by all accounts, were very well attended, presumably indicating a hunger on the part of the retail audience to learn, not only the marketing message behind these products, but also the science. (Several of these presentations had well in excess of 100 attendees. At Nutracon a few days earlier, the Sterling Rice Group, in a presentation entitled 'Fortified Foods Change Focus: Challenges and Opportunities' had commented on increasing consumer interest and attention to messaging, identifying that as a supplier, there was an opportunity to educate (without preaching), that a wellness/treatment balance appeared to be getting some traction, that consumer expectations are increasing, specifically relating to both quality and efficacy. What I found most interesting, especially since it was the first time I ever heard this specifically expressed, consumers are beginning to understand the concept of efficacious dose. If this is in fact true, this is significant for supplements, foods and all of our related industries.
For the past few years, we've been watching the emergence and relative disappearance of the 'low carb' fad, trying to identify the sustainable trend that could be marketed going forward. Some would call it part of a 'lesser evil shift' and this is certainly borne out by an examination of the show floor, as well as the presentations, through Nutracon and running throughout Expo. Gluten-free, smart carbs, carb control, slow carbs and many other terms were all in evidence. It also became quite apparent that the general trends of nutritional awareness, and an increase in knowledge of metabolism have emerged over the past few years. One of the outcomes of this evolution, despite critics who exclaimed that the concept was too technical, is an awareness of the term 'glycemic index' and a basic understanding of what it means in terms of food choices. I think, based on my own show observations, that this term and concept will stick around.
In other developments, just prior to the actual show opening, a strategic relationship between NSF International and the American Herbal Pharmacopoeia (AHP) was announced. NSF, over recent years, has been aggregating quality assurance, testing and certification programs, including QAI and the Institute for Nutraceutical Advancement.
It's been a busy week back, but these have been some of the musings I've had - so far.