By Len Monheit
When I first read the release issued by four industry trade associations (AHPA, CHPA, CRN and Natural Products Association) about the Standardized Information on Dietary Ingredients (SIDI) protocol, I was a bit perplexed not only as to what it was describing from a system standpoint, but also the scope of its objectives. I feel a lot more knowledgeable now after several key conversations, including one this week with Dr. Andrew Shao, CRN's V.P. of Scientific and Regulatory Affairs.
This project to standardize information exchange on dietary ingredients, comes in response to many factors, and if deployed successfully, represents potential benefits not only for ingredient companies, but also for other value chain partners (including even retailers) seeking to streamline processes and get better understanding of product inputs.
Current practice involves the completion of a questionnaire by a vendor and some sort of qualification process. As each vendor has their own questionnaire and qualification criteria, this can be very inconsistent, but also it means that vendors are completing multiple questionnaires in many different formats, and in many cases, the information requested may not be appropriate or relevant, or information that should be asked, is omitted. So completion of these multiple questionnaires is an issue for the suppliers, while review and consideration of these multiple page documents becomes a manufacturer’s issue. Change control, especially as we consider GMP impact, is another area of concern.
The intended goal of the SIDI system is to eliminate the resource requirement of the questionnaire-based system, in completion, evaluation and cost of error, to ensure that appropriate, meaningful information is provided for each ingredient, and to enhance consistency. The SIDI presentation (one place this is available is at www.crnusa.org/SIDI) also makes the point that rapid retrieval and then accessibility by FDA are also system benefits. Retailers and consumers also potentially benefit, the former in a desire to know more about what goes into the products they buy, and the latter in potential improvements in product safety or quality as buying practices improve.
Under the proposed system, ingredient data sheets, in a standard format, would be sent to manufacturers instead of questionnaires. Far from commoditizing the ingredient offering, if prepared properly, and if the ingredient properties are well defined and understood, these sheets can differentiate unique products or even unique knowledge of a product – in a standard, accepted format. If manufacturers are willing to replace questionnaires with this system, then for the ingredient companies, one would think this is a ‘no-brainer’. If manufacturers, as intended in the SIDI system, compel their suppliers to use this format, then adoption of this system is only a matter of time.
That leads to an interesting consideration. In any new system proposal, there has to be several factors for a conversion to be successful. First, there has to be a sponsor. Second, there has to be pain (felt and acknowledged) by system users. Third, there has to be a driver for (culture) change (often a regulatory or legislative driver). There also needs to be a mechanism for change to be implemented (a process consideration – who, how, what), and there needs to be a communicative consideration (how are we doing, what are the next steps, what’s going right and wrong, what are the goals).
The SIDI proposal has several advantages. First, as a collaborative effort on the part of AHPA, CHPA, CRN and the Natural Products Association, and through the efforts of the working group that has developed it, already it has some level of both endorsement and implied acceptance in the industry. On this issue, presumably most will acknowledge there is pain, in many cases significant pain, and with a bit of labor up front, ultimately that pain will be reduced – for both manufacturers as well as suppliers. The issue of a change driver is a bit unclear, and is probably the most important aspect of this concept. While compliance becomes easier, this system itself is not required for compliance. If manufacturers do in fact make the use of this system a supplier obligation, the driver is in force – all it requires is manufacturer commitment, solidarity - and a deadline. The process consideration appears well in hand with obvious phase-in issues (once again deadlines or target dates etc), and the communicative consideration should be adequate with the four trade associations actively engaged and communicating on an ongoing basis. In addition, the creation of other documents (site quality review and supply chain security) will provide lots of opportunity for ongoing communication and status reports. (These documents are targeted to be finalized by the first part of 2007)
So, what do I think?
Well, first let me backtrack a bit to previous columns and comments. Industry as a whole needs to get the value chain asking more and better questions and the system of supply and related quality issues needs to be much more transparent in order for us to be a better industry (liberally paraphrased)
It seems to me that this system, while certainly not a total solution to all industry’s problems, takes measurable steps towards doing exactly that. In fact, anything that has a chance of improving buying practices will have a significant impact. (One can’t help but wonder what will happen when that (offshore perhaps) low-cost supplier, despite mandatory SIDI requirements, comes up a bit short on documentation or refuses to participate – although that certainly happens in the current environment too)
I’m encouraged by what I see – in several ways. First of all, the collaborative effort behind this makes adoption more likely. Secondly, the system has obvious benefits at multiple stages of the value chain – suppliers and manufacturers benefit and should be able to quantify much of the benefit. Finally, industry has to take both initiative and responsibility to make itself better including practices towards self-regulation. I see this as one such step.