AOAC Stakeholder Panel on Dietary Supplements: Chondroitin Working Group. Meeting Minutes Friday, June 20, 2:00 p.m. EDT

Transcription

1 Stakeholder Panel on Dietary Supplements: Chondroitin Working Group Friday, June 20, 2:00 p.m. EDT Jana Hildreth, Blaze Science Industries (Chair) Brian Fischer, NBTY Gabriel Giancaspro, USP Martha Jennens-Clough, Covance David Ji, Analytical Laboratories Anaheim James Neal-Kababick, Flora Research Institute Catherine Rimmer, NIST Shauna Roman, Reckitt Benckiser Aniko Solyom, GAAS Corporation John Szpylka, Silliker Jason Williams, Galbraith Labs John Woods, Thorne Research Seong-Jae Yoo, Pharmavite LLC Weiguo Zhang, Synutra International Staff Scott Coates Christopher Dent Dawn Frazier Deborah McKenzie I. Welcome and Introductions II. Purpose of Standard Method Performance Requirements (SMPRs) Coates explained the Alternative Pathway / SMPR system for methods to become Official Methods of Analysis (OMA). The standard is developed by a working group and voted on by a stakeholder panel. Future methods will need to meet that standard in order to achieve OMA status. III. Chair s Recommendations for Working Group At last meeting we came up several fitness for purpose methods were developed. Hildreth said she believes the group should focus on the purity method (#4) ensuring that what is going into products is actually Chondroitin. IV. Applicability Statement Coates requested that the group provide more information on what a purity method means to help him put together a straw-man SMPR. A detailed applicability statement is required. The group agreed that a quantitative method is needed to measure Chondroitin, but that a screening method to look for adulterants is also important, so two SMPRs may be required. Coates will develop two strawman SMPRs for the group to work from. 6/20 SPDS Chondroitin Working Group v0.1 06/26/14

2 V. Timescales Frazier told the group that the expectation is for this working group to present its SMPR(s) to the Stakeholder Panel on September 5, Allowing for a one month comment period, this makes the deadline for a draft SMPR July 25, VI. Adjourn The meeting adjourned at approximately 3:00 p.m. JUNE 20, 2014 SPDS CHONDROITIN WORKING GROUP: ACTION ITEMS Develop straw-man SMPRs based on this discussion Coates Schedule next Working Group meeting Dent 6/20 SPDS Chondroitin Working Group v0.1 06/26/14

3 Stakeholder Panel on Dietary Supplements: Chondroitin Working Group Wednesday, July 2, 2014, 2:00 p.m. 4:00 p.m. EDT Jana Hildreth, Blaze Science Industries (Chair) Joseph Betz, NIH Brian Fischer, NBTY Gabriel Giancaspro, USP Martha Jennens-Clough, Covance James Neal-Kababick, Flora Research Labs David Kennedy, Phenomenex Punam Patel, Pharmavite Shauna Roman, Reckitt Benckiser Brian Schaneberg, Starbucks Aniko Solyom, GAAS Corporation Jason Williams, Galbraith Laboratories John Woods, Thorne Research, Inc. Seong-Jae Yoo, Pharmavite Weiguo Zhang, Synutra International Garrett Zielinski, Covance Staff Scott Coates Christopher Dent Dawn Frazier Deborah McKenzie I. Introduction and Roll Call Roll call was taken and the meeting commenced at 2:00 p.m. EDT. II. Review of Draft SMPR Documents Coates reminded the group of its earlier decision to move forward with two sets of Standard Method Performance Requirements (SMPRs), one for detection of adulterants and one for the determination of total Chondroitin sulfates. The group discussed the need for the second SMPR and agreed that although there are already methods for total Chondroitin out there, without an SMPR they cannot become Official Methods of Analysis (OMAs) and therefore the second SMPR is necessary. a. Screening SMPR The group proceeded to review the straw-men SMPR for screening methods. All agreed to remove glucosamine from the target list and to add over-sulfated Chondroitin to Annex I. Definitions: The group reviewed the definitions section. Betz said he will send the definition for adulterants to Coates. Giancaspro offered to put together a sentence to help clarify the structure figure of Chondroitin. SPDS Chondroitin Working Group Telecon, July 2, 2014 v0.1

4 Method Performance Requirements - Single Laboratory Validation: Coates stated that the POD of 95% could be pooled from a combination of target compounds and matrices. There were no objections to this suggestion and the change was made under Matrix Studies. For Low Concentration the group agreed that 5% target test concentration is too high this was discussed and all agreed to a target test concentration of 2%. Additional matrices were also added, specifically chews and gummies. Method Performance Requirements - Multi Laboratory Validation: Under High Concentration Coates agreed to develop language for selectivity. LPOD: 5% was changed to 2% as with the low concentration section. Reference Materials: Reference materials were discussed. What reference materials can be used for adulterants? The group suggested tabling this issue for now and revisit this before the standard is put up for public comment. Maximum time to result was then addressed. The group believed that more research is needed on this issue. Kababick volunteered to provide more information on this. Annex I was then revisited. Hildreth stated that she will do more research on this and get back to the group. for Hildteth. III. Adjourn The discussion was concluded and the meeting adjourned at approximately 4:00 p.m. EDT. JULY 2, 2014 SPDS CHONDROITIN WORKING GROUP: ACTION ITEMS Send definition of adulterants to Coates Betz Clarify structure figure for Chondroitin Giancaspro Develop language around selectivity. Coates Gather more information on maximum time to analysis. Kababick Gather more information for Annex I Hildreth Make changes discussed above to straw-man SMPR document SPDS Chondroitin Working Group Telecon, July 2, 2014 v0.1

5 Stakeholder Panel on Dietary Supplements: Chondroitin Working Group Friday, July 11, 2014, 1:00 p.m. 3:00 p.m. EDT Jana Hildreth, Blaze Science Industries (Chair) Joe Betz, NIH Brian Fischer, NBTY Gabriel Giancaspro, USP Martha Jennens-Clough, Covance David Ji, Analytical Laboratories in Anaheim Aniko Solyom, GAAS Corporation John Szpylka, Silliker John Woods, Eppendorf Weiguo Zhang, Synutra International Staff Scott Coates Christopher Dent Dawn Frazier I. Welcome and Introductions The meeting commenced at 1:00 p.m. EDT and roll call was taken. II. Review of 7/2 Items items were reviewed. Giancaspro has provided clarity around the structure figures, new action for to incorporate this new information into the SMPR. Betz had provided a definition for adulterants which Coates has incorporated into the latest draft of the Chondtoitin SMPR. Betz advised that a footnote will be needed, stating that this definition has been modified from the original law (21-CFR). III. Completion of SMPR for Screening Methods Discussion continued on the SMPR for Screening Methods. The group agreed to modify the title from detection of to screening for. The changes from the last meeting were reviewed and accepted. Spzylka recommended including journal references on top of the OMA references, action for to add these. Annex I was then reviewed and a discussion on over-sulfated polysaccharides ensued. for Giancaspro to provide examples of over-sulfated polysaccharides which will then be put in parenthesis in the annex For reference materials the group agreed to cite NIST and USP information. for to find the appropriate references. IV. Review of Straw Man SMPR for Quantitative Methods / Total Chondroitin SPDS Chondroitin Working Group 07/11/2014 Teleconference v0.1

6 Definition of chondroitin was modified as per the change to the screening SMPR. Analytical range for the SLB was changed to 1-10% for low, and >10-100% for high. With an LOQ of 1%, and repeatability set at 3 for low and 2% for high. Recovery was changed to % for low and % for high. In the multi-lab study, reproducibility was changed to 6% low and 4% high. The group agreed to make reference materials consistent with the wording in the screening method and to include a reference for Appendix K under Validation Guidance. In Annex I: Chondroitin Sulfate Compounds to be Evaluated, Solyom agreed to develop a list of compounds to discuss at the next meeting. V. Next Working Group Meeting staff agreed to send out the next appointment notice shortly. VI. Adjourn July 11, 2014 SPDS Chondroitin Working Group: ACTION ITEMS Add reference to law that adulterants definition was adapted from Provide examples of over-sulfated polysaccharides Giancaspro Add J references to MPR table Find appropriate USP/NIST references for reference materials Develop list of compounds for Annex I Solyom SPDS Chondroitin Working Group 07/11/2014 Teleconference v0.1

7 Stakeholder Panel on Dietary Supplements: PDE5 Inhibitors Working Group Friday, July 18, 2014, 1:00 p.m. 2:00 p.m. EDT Staff i. Welcome and Introductions Roll call was taken and the meeting commenced at approximately 1:00 p.m. ii. iii. iv. Review of Adulterants SMPR Coates reviewed the changes made to the SMPR since the last meeting. Giancaspro advised that the letter B needs to be replaced with a β in the structure figure. The group noticed other minor formatting changes, action for to correct any format issues. Review of Total Chondroitin SMPR. Coates reviewed the changes made to the Total Chondroitin SMPR since the last meeting. Under Validation Guidance the group added the phrase Candidate methods should be challenged with materials known to interfere with the assay. This was done in lieu of listing the potential materials. The group determined that Annex I was not necessary and removed it. Annex II, Matrices, then became Annex I. The group also agreed that concentrates and extracts were no both needed in the Annex, and Concentrates was removed. Next Steps Coates reviewed the next steps in the process. The SMPRs will be posted on the website for a public comment period for one month. Coates, as Chief Scientific Officer, will review the comments in conjunction with Hildreth. If necessary, another working group meeting will be held at that time to reconcile the comments. After that, Hildreth will present the final SMPR to the Stakeholder Panel on Dietary Supplements at the September 5, 2014 meeting for approval and adoption as an standard. v. Adjourn The meeting adjourned at approximately 2:00 p.m. EDT. JULY 18, 2014 SPDS Chondroitin Working Group: ACTION ITEMS to make final edits and make SMPRs ready for public comment period SPDS Chondroitin Working Group 7/18 V0.1