February 22, 2010
Presumably the hype has moderated at least a bit, and we can now truly consider the implications of the Dietary Supplement Safety Act of 2010, introduced by Senator McCain a few weeks ago. Predictably, the pending legislation set off a firestorm both in and outside of industry, and also predictably, industry’s detractors were quick to jump on the bandwagon, while those fearing an organized attack on the existing regulatory environment quickly mobilized their support.
So just where do we currently stand on this issue? How vulnerable are we?
First of all, industry experts have stated that the chance of the legislation passing ‘as is’ is quite remote. Far more problematic they say, is the chance that some of this language gets inserted into other legislation, almost as an afterthought, and hence becomes ‘law’. So that’s presumably something to watch out for.
Examining the suggested legislation, it’s probably worthwhile to let at least a bit of logic prevail. Starting with the AER piece where all AERs instead of just serious AERs become reportable, presumably, at some point in the dialogue, someone would engage the FDA to determine whether they can cope with this in any fashion, which they obviously can’t. But, more needless processes than this have become entombed in law and so industry must gear for a logical battle on this front.
The second burning issue in the proposed legislation has to do with the approved list of ingredients replacing the grandfather provision of DSHEA. Travis Tygart, USADA and the sports community have vehemently (and consistently) argued the necessity of this provision, claiming they say, that ambiguity in the current environment enables unscrupulous retailers to offer suspicious ingredients that may have a link to grandfathered products, but were certainly not in commerce as ingredients pre-DSHEA. This is a real issue, and one that all who investigate will recognize as a safety threat. It’s for that very reason that industry has eagerly awaited FDAs planned guidance document on NDIs (New Dietary Ingredients) so that some of the ambiguity can be explored and hopefully removed. Unfortunately though, the guidance/response process is not likely to be without its disagreements and a protracted process once we actually see that initial guidance and can discern FDAs thinking in this area, might allow for more momentum to accumulate behind this Act’s ‘approved list.’ This would be extremely dangerous, as I personally see this as one leg of the proposed legislation that industry justifiably opposes, but that could garner enough public and legislative attention to become a serious threat. And if the grandfathered ingredient provision of DSHEA is changed in this fashion, the industry as we know it will dramatically change, as will all the parameters for new product development.
Now, let’s face a bit of reality. As FDA issues their guidance document and the interpretation of just what does constitute a New Dietary Ingredients becomes clear, and hopefully, somewhat agreed upon between FDA and industry, some of the products currently on the market will have to undergo a New Dietary Ingredient submission process. At least through the guidance process, industry has a seat at the table (or maybe it’s in the next room, but it’s a seat anyway) , and for this reason industry should be pushing for action on this subject by FDA to begin this dialogue – full stop. It may be that the best way to diffuse this argument in the proposed legislation is to be actively engaged in bettering the existing system – which has serious flaws, ambiguities and interpretive differences. With this ‘issue’ removed from the hit list of the sports community, and the specific ambiguity that they are concerned with being effectively dealt with, the drive of McCain’s legislation loses an important engine.
Let’s take a step back on this issue. Should the legislation have come as a shock? Did we have warning that the Supplement Safety now initiative would get aggressive?
We certainly did and so this legislation, in that context, was quite predictable. Strategically, it was even more so, and from at least two separate viewpoints. The first is ‘why not try for legislation, however poor or flawed the inherent logic, in order to table all one’s desires?’ If it ‘passes, great, but even if not, you’re controlling the dialogue, the headlines, and when it’s the sports community and athletes, the message resounds and takes on a will of its own that helps further the cause. The second issue (and I actually think this may be even more important in this case) is to gauge industry’s readiness and ability to fight an objective, logical campaign on real issues, and to support ‘reasonable change’. For if we as industry are seen to be unreasonable on this issue, we’d better prepare for the worst, as public sympathy could very well not be on our side.
Stay tuned for the next chess move in this campaign. This legislation is the sports community’s latest salvo, and probably not even the anticipated full-out declaration of war. For us to deal with it improperly could be devastating.
In two weeks at SupplyExpo, you can discuss and debate these and other developments at booth 112 in a Sunday session entitled: ‘Regulatory Issues to Watch’, March 14, 2010 in Anaheim.
Side note: Muddying the waters has been recent requests by GAO for documentation illustrating presence in commerce, prior to 1994 of several herbal ingredients. Apparently, these actions are at the request of the Senate Committee on Aging, and have dealt with rather ‘innocuous’ products such as peppermint and echinacea. Those industry experts I’ve spoken with cannot confirm a motivation behind these requests but since the process to get GAO involved is protracted, it’s timing now when this legislation is brewing is coincidental.
Second side note: At a UNPA GMP seminar last week, I spoke with several colleagues whose experiences confirmed that FDA’s inspection approach may not alter industry’s product quality dilemma adequately. This could also impact momentum behind the sports community’s call for more active legislation. More on that in a future editorial.
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