By Len Monheit
Dietary supplements regained major headline status with the release of the US Institutes of Medicine (IOM) report entitled "Use of Complementary and Alternative Medicine (CAM) by the American Public". Quite predictably, media headlines immediately picked up on the IOM's call for additional regulations for dietary supplements, and even noted the report's argument that dietary supplements, subject of a 30 page chapter in the 300 page report, should go through the same safety and efficacy process as other medical treatments. CRN, AHPA and NNFA have all issued releases regarding this report, with the CRN release referring to an 'Unwarranted Hatchet Job on Supplements'.
The argument made by the report focuses on quality, safety and efficacy, and comments on the inadequacy of research, recommending additional allocations. It notes the lack of supplement GMP's without demonstrating an understanding of the fact that in the absence of supplement GMP's, food GMP's, in their entirety, apply to the industry. Noting the lack of a pre-approval process, the report seems to ignore the fact that New Dietary Ingredients are subject to a pre-approval process with the US FDA.
Evident in the communication about the report, are many of industry's current dilemmas, and the broad coverage and pickup indicates that despite regulatory and legislative progress in the last year or so, battles are yet to be waged, the security of DSHEA is not assured, and in order to broaden its support base among consumers and medical practitioners, fundamental issues must be addressed and challenged at every opportunity.
Let's take NDI's.
The current open comment period regarding New Dietary Ingredients and the process of clarifying submission requirements, while extremely valuable, both as a dialogue with FDA, and for its potential impact on examining the status of post-1994 ingredients, and new forms of pre-1994 ingredients, will not ultimately do much to change the perception of a lack of 'any' pre-approval process for supplements. Without a registration system that covers both safety and efficacy of ingredients and finished products, the argument cannot be eliminated. True, efficacy must be established in order to present structure-function claims, and true, there is a mechanism where both the FTC and FDA have a role with unsubstantiated claims, but these are both post-market activities, and according to current dialogue, will be dealt with on a risk-based approach. So, to fundamentally dismantle the perception of no pre-approval for efficacy and a compromised at best, safety pre-approval mechanism is almost impossible.
Now for GMP's.
The release of supplement GMP's will not fundamentally change the perception that poor quality products are on the market - at least without significant GMP enforcement. Companies in this industry have been applying NNFA GMP's and NSF and other programs for some time now, and while these programs and third party quality assurance activities in many cases have some market benefit, fundamentally, supplement GMP's will only give a framework and authority for the FDA and industry. By themselves, published GMP's will do little or nothing to raise confidence about supplement safety or quality. Theoretically, if GMP's were to have any effect on confidence, the current food GMP's should have already generated that effect.
What about efficacy?
The other challenge for industry is to demonstrate product efficacy. When I spoke several months ago as an industry representative at a symposium organized by the World Anti-Doping Association (WADA), researchers in sports nutrition were as concerned with efficacy as they were with safety. And it's not only the research community that is fundamentally concerned, it's a significant portion of an increasingly cynical mainstream population. Combine this issue with, at least for many supplements, an alleged preventative impact which is extremely difficult to measure, especially in the short-term, and you have an almost insurmountable challenge. Most of us have heard the argument that without an Intellectual Property and patent position, clinical trials are difficult, if not impossible to justify. If the preventative effects you're alleging to prove take ten to fifteen years to manifest, just what are you supposed to do? The argument gets a lot weaker for products with shorter term, measurable impact, and this is where the IOM report, calling for additional allocations towards research, does make some sense. Somehow, the infrastructure and programs involved in supplements and natural products research must be expanded.
Incidentally, as I write this, the "2nd Natural Health Product Research Conference and Trade Show: Integrating Basic and Clinical Research", will be held February 11-13 in Vancouver, BC. To register, visit http://www.nhpresearch.bcit.ca/registration.html.
Fundamentally, you can't challenge or change someone's convictions. All you can do is present to them observations and facts that work to undermine the logic of their convictions and beliefs. And you must be persistent and consistent. For many in our target audience, their perceptions are, in fact, convictions.
Ultimately, if the argument above is logical, then the only recourse to change perception is to either re-evaluate DSHEA, or for industry to examine other steps, systems and processes that will ensure companies with products on the market are compliant, that the safety record of the industry is well-documented, that non-compliant companies are easily recognized in all of products, practices and claims, and that a platform of confidence can be established that deals with all aspects of quality, safety and efficacy. And this platform must be widely presented, broadly understood, simple, endorsed and enforced.
Absent and conspicuous by its absence in the last few weeks is any dialogue surrounding Adverse Events and AER's. Last year very much on the radar and the subject of bi-partisan Senate support, industry was called upon to take proactive steps to put forth a proposal for a viable AER system that would do several things. First of all, it would begin to answer allegations that there was no accountability mechanism for serious adverse events proven to be due to the use of supplements. Secondly, it would become a tool, if established properly, to document industry's safety record. Perhaps there is momentum and dialogue behind the scenes, because I certainly hope the opportunity for industry to proactively present a system it has totally bought into, to regulators, legislators, media and consumers, is not squandered.
In addition, given the likely absence of enforcement will or ability, industry self-policing as well as third party assurance systems, have never been more important. Critical to these activities is a mechanism explaining these systems and their impact on the supplements market, the products that reach or do not reach the marketplace and the story they tell.
It is unfortunate that the IOM report is as skewed as it is. It is unfortunate too that the report's audience and both media and consumers are likely to be influenced by its tone, assumptions and conclusions.
I did find it interesting to read an article from USA Today entitled, "Non-traditional medicine is no fad". The article, unlike many others reporting the release of the IOM report, also includes comments from ABC's Mark Blumenthal and CRN's Judy Blatman, and attempts to put the IOM report into context and balance its perspective. This article also refers to a study published in the January/February issue of the medical journal Alternative Therapies in Health and Medicine.) This study suggests that the use of CAM (all categories) is steady between 1997 and 2002.
With some proactive measures to address the concerns above, where could these numbers be?