By Len Monheit
How often do we, with the best of intentions, set off on a mission, usually about half way through, that despite those best intentions, we have not even partly succeeded in executing. Perhaps, it’s a failure to anticipate and plan for contingencies, maybe it’s a change in priority, frequently it’s simply a failure to execute, and sometimes, the opposition (or the inertia) is just too strong.
Last week, CFSAN issued its Program Priorities Report Card for 2005. The agency gave itself a 78% (87 out of 111) on its program priority accomplishments, tied for the lowest rating since 1999. In a year where it said it was hampered by resource cuts, it successfully ‘completed’ 3 “A” list goals involving dietary supplements, with the 87 list items completed being the lowest total since 2000. ("A" List accomplishments represent specific objectives that the agency feels are critical to the mission of either the Center, the Agency or the Administration.). Specifically related to Dietary Supplements:
- Held Public Meeting on 75-day Pre-notifications for New Dietary Ingredients.
- Developed a Strategy for Implementing DSHEA.
- Published Dietary Supplement Labeling Guidance for Industry.
As it turns out, two of these ‘accomplishments’ occurred in November 2004, the other in April 2005.
It becomes obvious that dietary supplements are not a priority. With general food safety and security looming as health threats, nor should they be, certainly when considered from a risk perspective. And we should be quite happy that the relative safety of supplements is not perceived to be a major issue or crisis. We might also read into the report text that, despite what might be the best of intentions, the supplements agenda is not likely to move fast if at all, as further FDA cuts have been announced. If industry is to take control of its own destiny, it must do so with minimal, if any, guidance and support from FDA.
So what does this mean?
First of all, the final GMP regulation, if issued, will essentially be at best, a reference piece of paper. Even if FDA had enforcement intention (there’s that ‘intention’ word again), the agency’s ability is severely compromised by both resources and the prioritization scheme. And enforcement will itself is suspect. Wouldn’t it be much better for the agency to let the industry continue its divisive and self-destructive path, so long as public health is not compromised?
Last year, FDA signaled it intention to clarify the procedure and policies surrounding New Dietary Ingredients. About as far as the agency got was Item #64. – Held a Public Meeting. In the absence of this clarification and fulfilling of intent by the FDA, companies are generally taking one of two tacks – either erring on the side of caution and submitting NDI applications, just to be sure, or anticipating that it will be some time before clarification is achieved, assuming in the meantime, a free-for-all market, and just plain, avoiding the issue entirely.
Now let’s take examine from an industry perspective. One would presume that fundamentally, there is every intention to be compliant. Business logic suggests though, that despite these intentions (what a nasty word), there are envelopes to be pushed, and advantage to be gained by being aggressive, utilizing ambiguity and gray areas strategically to secure market advantage. And for those that have no intention of even trying to be compliant, (and we know that there are definitely far too many currently operating in the supplements environment) there is almost no risk and huge reward for every day they manage to stay in operation. Here, intentions are quite straightforward – make money while you can.
Let’s swing across the border and take a look at Canada, from the perspective of regulatory intention. The Natural Health Products Directorate was formed to deal appropriately with products that were recognized as being different and separate from food or drug. Whether you like the principle of the regulations or not, whether you feel that they are too food-like or drug-like, that was the intent of the regulations. And the products are treated differently, so in that measure of reaching intention, the regulations deserve good, if not full, marks.
Part of the intention of the regulations was to allow consumers access to safe and effective products. One can argue convincingly that the site and product license mechanism assures a measure of safety, and so there are currently some 1000 plus products on the market that have met the intent of the regulations. Over 10,000 license applications in the queue, NHPD moving back some of the priority dates by an additional year, and announcing that companies should not be placing ‘NPN pending’ on their labels all hint at serious problems and challenges, despite well-meaning regulatory intent. Although some would argue that the Directorate is improving both turnaround times and communication, it is evident that part of the intent of the regulation, access to products, is not currently being fulfilled. It is even more disconcerting in that the current environment is stifling Canadian will and ability to innovate. If relatively simple products are challenging to present to the market, what hope is there for innovative, cutting edge ones? What prospect for return on investment? Perhaps even more threatening is the rumbling that ‘functional food and beverage’ product approvals, an area where Canada already lags behind much of the world, is currently the subject of branch level review with all energy drink submissions on hold pending this review.
Sources indicate that despite the science continuum, which begins with natural, health conferring ingredients, all judgments and decisions relating to functional foods and beverages will in the future reside with entirely within Canada’s ultraconservative Foods Directorate, and not involve the Natural Health Products Directorate, a move that in principle would seem to be totally at odds with the intent of Canada’s Natural Health Products regulations in the first place. The impact on health, or rather the potential wasted, would be enormous. One wonders at the intent of those making these decisions.
Examining this landscape brings rise to an interesting issue. In most courtrooms, intent has a bearing not only on the seriousness of the crime, but also on the sentence. If that is to be true in our business environment, then certainly part marks must go to the regulators and the sentences should be less harsh. One might argue though that in the hard cold business environment, intentions count for nothing and we are all measured for results, and therefore so should be the regulators. In this case, the results suggest dismal failure since, despite intentions, on both sides of the border, intentions are fundamentally not being met.
There is one other area that must be measured and that is effect on human health, presumably a major intention of our industry. Here, industry and the regulators get mixed reviews. Both are striving towards high product safety, and would seem to be doing exceptionally well. On the flip side though, one objective is the bringing to market of effective, health-impacting products and of changing human health conditions. In Canada, that objective is ironically being stifled by the regulatory environment, and in the US, comments about lack of industry regulation, and the inability to make substantiated comments about products and ingredients prevent market growth and a serious positive impact on human health. So, we are falling far short of our potential for impacting human health, and that should be a concern to us all.
CFSAN’s 78% performance measurement is a signal, as are its 2006 indicated priorities. In Canada., NHPD’s many thousands backlog of unprocessed product license applications is also a signal, a signal that despite intentions, execution ability is flawed. While in government, a 78% success rate might be tolerable or at least accepted, in business, it can mean the difference between success and failure. It’s obvious then that it’s up to industry to deliver on its intentions, individually and collectively. One of our biggest tasks though, is to make sure that we’re crystal clear on our intentions.
We must decide if the fundamental intention is exclusively to make money or if the clause ‘while positively impacting human health’ goes along with it. I’m not to much of an idealist to understand and appreciate the first part, I happen to think the qualifier is important too.