Joint Committee on Dietary Supplements

  • 1.  Irreparably defective

    Posted 11-07-2023 01:28 PM

    Hi Rachel 

    Please clarify, is the "irreparably defective"173 task group going to continue to meet? And is the 455 JC going to implement anything before the 173 TG finishes hashing out the various issues this topic raises?

    Because it sounded to me like it may have been decided to discontinue the 173 TG and only have the issue continue under the 455 JC, and/or to have the 455 JC implement provisions related to "irreparably defective" without waiting for the 173 TG to complete its work....?

    If so then I want to object to that course of action. There are several people on the 173 JC who have relevant knowledge & experience to contribute and we shouldn't have to join a whole different JC (455) to ensure our concerns are heard.

    To my knowledge the 173 "irreparably defective" TG met once and identified various things to be done, but I'm not aware of those items being completed. (I may have missed a subsequent TG meeting? but I haven't seen anything coming out of the TG that seemed like it completed the identified work) The TG should not be discontinued until the TG has finished its work or until the members of the TG are satisfied with the course of action that will be implemented.

    And of course it would be ill-advised (IMO) for the 455 JC to implement anything without the input of the experts on the 173 JC.

    Besides getting very clear about the scope of "irreparably defective," which from what I've seen is currently being *badly misinterpreted* by members of industry, I think there are various other provisions that should be considered. 

    • Rather than mandating that all "irreparably defective" materials must be destroyed, there should be an explicit option for the vendor to arrange delivery of the material within X time period to an appropriate alternate user of the material. 
      • For example, if rose petals are somehow contaminated then they may not be suitable for the food supply but they could well be suitable for use by a company that makes potpourri or perfume. They could also be usable by a different food company with a different manufacturing process that addresses the contamination.
    • It may also be a good idea to identify and define a category of "reparably defective" materials for which the vendor is explicitly provided the opportunity to take the material back or arrange remediation of the problem on behalf of the buyer (e.g., sending material out to be steam sterilized or whatever).

    contamination bad enough to constitute an actual public health risk, the steps proposed above would presumably be subject to approval by FDA under the RFR provisions; I don't know the details of how FDA handles those cases.)

    I continue to think that NSF can play a constructive role in helping to *appropriately focus* the efforts of the "irreparably defective" proponents in the industry, so that the outcome serves to actually protect public health while also not causing pointless economic costs to industry and consumers. However, from my point of view the project is not at all close to reaching that goal so far.

    Please confirm the status of the 173 TG and please confirm whether the 455 JC plans to implement any provisions related to "irreparably defective" prior to completion of work by the 173 TG?



    Staci Eisner
    Cortex Scientific Botanicals
    541-973-2252 x225

  • 2.  RE: Irreparably defective

    Posted 11-07-2023 01:55 PM
    Hi Staci, I hear you, understand your concerns, and want to reassure you of my intent:

    1) This will continue by Health Business Strategies in NSF 173. I started with 173, knowing that, one day, it'd need to advance it to 455.  That day is now.

    2) I share your frustration w/my not moving this forward faster. Competing issues + limited bandwidth has slowed my progress. Yes, I am extremely frustrated too. Life happens.

    3) All that said, and with the additional resources now supporting the IDA concept that is constructively wrapped in linguistic precision that most/all stakeholders will support, will really help move this to it intended effect, while carefully avoiding the concerns voiced by Michael and a few others. 

    Education is mission critical. 

    Thanks for your questions/constructive feedback.

    Cheers!~  Michael

    On Nov 7, 2023, at 10:28 AM, Staci Eisner via NSF Standards <> wrote:


    Michael D. Levin
    Health Business Strategies, LLC
    12042 SE Sunnyside Rd
    Clackamas, OR 97015